Dr Dhruva Kumar Sharma

Department of Pharmacology

SMUSMIMS

Saturday the 19th Of July 2014

Evolution of Good Clinical

Practices

An overview

2

PROTOCOL

bull Nazi war crimes

bull Tuskegee syphilis trial

bull Thalidomide disaster

bull Jews chronic disease trial

bull Neuremberg trial code

bull Declaration of helsinki

bull Belmonte report

bull ICHGCP Guidelines

3

Good Clinical Practice (GCP) Meaning

4

Good Clinical Practice (GCP) is an international

ethical and scientific quality standard for designing

conducting recording and reporting trials that involve the

participation of human subjects

Compliance with this standard provides public

assurance that the rights safety and well-being of trial

subjects are protected consistent with the principles that

have their origin in the Declaration of Helsinki and that

the clinical trial data are credible

bull The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU) Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

5

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

Evolution of Good Clinical

Practices

An overview

2

PROTOCOL

bull Nazi war crimes

bull Tuskegee syphilis trial

bull Thalidomide disaster

bull Jews chronic disease trial

bull Neuremberg trial code

bull Declaration of helsinki

bull Belmonte report

bull ICHGCP Guidelines

3

Good Clinical Practice (GCP) Meaning

4

Good Clinical Practice (GCP) is an international

ethical and scientific quality standard for designing

conducting recording and reporting trials that involve the

participation of human subjects

Compliance with this standard provides public

assurance that the rights safety and well-being of trial

subjects are protected consistent with the principles that

have their origin in the Declaration of Helsinki and that

the clinical trial data are credible

bull The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU) Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

5

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

PROTOCOL

bull Nazi war crimes

bull Tuskegee syphilis trial

bull Thalidomide disaster

bull Jews chronic disease trial

bull Neuremberg trial code

bull Declaration of helsinki

bull Belmonte report

bull ICHGCP Guidelines

3

Good Clinical Practice (GCP) Meaning

4

Good Clinical Practice (GCP) is an international

ethical and scientific quality standard for designing

conducting recording and reporting trials that involve the

participation of human subjects

Compliance with this standard provides public

assurance that the rights safety and well-being of trial

subjects are protected consistent with the principles that

have their origin in the Declaration of Helsinki and that

the clinical trial data are credible

bull The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU) Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

5

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

Good Clinical Practice (GCP) Meaning

4

Good Clinical Practice (GCP) is an international

ethical and scientific quality standard for designing

conducting recording and reporting trials that involve the

participation of human subjects

Compliance with this standard provides public

assurance that the rights safety and well-being of trial

subjects are protected consistent with the principles that

have their origin in the Declaration of Helsinki and that

the clinical trial data are credible

bull The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU) Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

5

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

bull The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU) Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

5

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

History

Why Do We Need Guidelines

Why Are We Regulated

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

Nazi Medical War Crimesduring World War II

bull Experiments conducted by Nazi physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected

bull Typically the experiments resulted in death disfigurement or permanent disability and as such are considered as examples of medical torture

Nazi Medical War Crimes

Medical experiments were performed onthousands of concentration campprisoners and included deadly studies andtortures such as-

Injecting people with gasoline and liveviruses

Immersing people in ice water

Forcing people to ingest poisons

9

Incisions made by

medical personnel

that were purposely

infected with bacteria

dirt and slivers of

glass

Victim of a tuberculosis medical experiment

10

Prisoner in a compression chamber

11

An experiment to

determine

altitudes at which

aircraft crews

could survive

without oxygen

Immersing people in ice water

bull With the intent of discovering means to prevent and treat hypothermia

bull 280 to 300 victims

bull One study forced subjects to endure a tank of ice water for up to five hours

12

9

Incisions made by

medical personnel

that were purposely

infected with bacteria

dirt and slivers of

glass

Victim of a tuberculosis medical experiment

10

Prisoner in a compression chamber

11

An experiment to

determine

altitudes at which

aircraft crews

could survive

without oxygen

Immersing people in ice water

bull With the intent of discovering means to prevent and treat hypothermia

bull 280 to 300 victims

bull One study forced subjects to endure a tank of ice water for up to five hours

12

Victim of a tuberculosis medical experiment

10

Prisoner in a compression chamber

11

An experiment to

determine

altitudes at which

aircraft crews

could survive

without oxygen

Immersing people in ice water

bull With the intent of discovering means to prevent and treat hypothermia

bull 280 to 300 victims

bull One study forced subjects to endure a tank of ice water for up to five hours

12

Prisoner in a compression chamber

11

An experiment to

determine

altitudes at which

aircraft crews

could survive

without oxygen

Immersing people in ice water

bull With the intent of discovering means to prevent and treat hypothermia

bull 280 to 300 victims

bull One study forced subjects to endure a tank of ice water for up to five hours

12

Immersing people in ice water

bull With the intent of discovering means to prevent and treat hypothermia

bull 280 to 300 victims

bull One study forced subjects to endure a tank of ice water for up to five hours

12

bull In 1946 an American military tribunal opened criminal proceedings against 23 leading German physicians Doctors Trial

bull Sixteen of the doctors were found guilty

bull Seven were sentenced to death

bull Development of the Nuremberg Code of medical ethics

13

THE DOCTORS TRIAL

The Tuskegee Syphilis Study

bull Research participants was the long-term study of black males conducted at Tuskegee Alabama by the United States Public Health Service

bull (1930s-1970) - examination of the natural history of untreated syphilis

bull More than 400 African-American men with syphilis participated

bull The men were recruited without informed consent and in fact were misinformed that some of the procedures done in the interest of the research (eg spinal taps) were actually special free treatment

The Tuskegee Syphilis Study

bull In the 1940s penicillin was found to be effective in the treatment of syphilis

bull The study continued however and the men were neither informed of nor treated with the antibiotic

bull The first accounts of this study appeared in the national press in 1972

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

The Jewish Chronic Disease Hospital Study

bull In 1963 studies were undertaken at New Yorks Jewish Chronic Disease Hospital to understand whether the bodys inability to reject cancer cells was due to cancer or debilitation

bull Previous studies had indicated that healthy persons reject cancer cells promptly and the researchers allegedly believed that the debilitated patients would also reject the cancers but at a substantially slower rate compared to healthy participants

The Jewish Chronic Disease Hospital Study

bull Further patients were not told that they would receive cancer cells because the researchers felt it would unnecessarily frighten them

bull It was found that the study had not been presented to the hospitals research committee and that the physicians responsible for the patients care had not been consulted

bull The researchers were found guilty of fraud deceit and unprofessional conduct

The Willowbrook Study

bull Institutionalized children as participants in research is demonstrated in a series of studies conducted from 1963 through 1966 at the Willowbrook State School a New York institution for mentally defective children

bull In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances newly admitted children were deliberately infected with the hepatitis virus

bull In some cases parents found they were unable to admit their children to Willowbrook unless they agreed to their childrsquos participation in the studies

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Tuskegee Syphilis Study

bull In the 1940s penicillin was found to be effective in the treatment of syphilis

bull The study continued however and the men were neither informed of nor treated with the antibiotic

bull The first accounts of this study appeared in the national press in 1972

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

The Jewish Chronic Disease Hospital Study

bull In 1963 studies were undertaken at New Yorks Jewish Chronic Disease Hospital to understand whether the bodys inability to reject cancer cells was due to cancer or debilitation

bull Previous studies had indicated that healthy persons reject cancer cells promptly and the researchers allegedly believed that the debilitated patients would also reject the cancers but at a substantially slower rate compared to healthy participants

The Jewish Chronic Disease Hospital Study

bull Further patients were not told that they would receive cancer cells because the researchers felt it would unnecessarily frighten them

bull It was found that the study had not been presented to the hospitals research committee and that the physicians responsible for the patients care had not been consulted

bull The researchers were found guilty of fraud deceit and unprofessional conduct

The Willowbrook Study

bull Institutionalized children as participants in research is demonstrated in a series of studies conducted from 1963 through 1966 at the Willowbrook State School a New York institution for mentally defective children

bull In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances newly admitted children were deliberately infected with the hepatitis virus

bull In some cases parents found they were unable to admit their children to Willowbrook unless they agreed to their childrsquos participation in the studies

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Jewish Chronic Disease Hospital Study

bull In 1963 studies were undertaken at New Yorks Jewish Chronic Disease Hospital to understand whether the bodys inability to reject cancer cells was due to cancer or debilitation

bull Previous studies had indicated that healthy persons reject cancer cells promptly and the researchers allegedly believed that the debilitated patients would also reject the cancers but at a substantially slower rate compared to healthy participants

The Jewish Chronic Disease Hospital Study

bull Further patients were not told that they would receive cancer cells because the researchers felt it would unnecessarily frighten them

bull It was found that the study had not been presented to the hospitals research committee and that the physicians responsible for the patients care had not been consulted

bull The researchers were found guilty of fraud deceit and unprofessional conduct

The Willowbrook Study

bull Institutionalized children as participants in research is demonstrated in a series of studies conducted from 1963 through 1966 at the Willowbrook State School a New York institution for mentally defective children

bull In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances newly admitted children were deliberately infected with the hepatitis virus

bull In some cases parents found they were unable to admit their children to Willowbrook unless they agreed to their childrsquos participation in the studies

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Jewish Chronic Disease Hospital Study

bull Further patients were not told that they would receive cancer cells because the researchers felt it would unnecessarily frighten them

bull It was found that the study had not been presented to the hospitals research committee and that the physicians responsible for the patients care had not been consulted

bull The researchers were found guilty of fraud deceit and unprofessional conduct

The Willowbrook Study

bull Institutionalized children as participants in research is demonstrated in a series of studies conducted from 1963 through 1966 at the Willowbrook State School a New York institution for mentally defective children

bull In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances newly admitted children were deliberately infected with the hepatitis virus

bull In some cases parents found they were unable to admit their children to Willowbrook unless they agreed to their childrsquos participation in the studies

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Willowbrook Study

bull Institutionalized children as participants in research is demonstrated in a series of studies conducted from 1963 through 1966 at the Willowbrook State School a New York institution for mentally defective children

bull In order to gain an understanding of the natural history of infectious hepatitis under controlled circumstances newly admitted children were deliberately infected with the hepatitis virus

bull In some cases parents found they were unable to admit their children to Willowbrook unless they agreed to their childrsquos participation in the studies

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Willowbrook Study

This controversial case raised important questions about the adequacy and freedom of consent inadequate disclosure of the childs risk of later developing chronic liver disease

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

The Milgram Study

bull The lsquoteachersrsquo were instructed to give the lsquolearnersrsquo electrical shocks in response to incorrect answers on verbally given lsquotestsrsquo

bull Participants were deceived as to the nature of the study being told it was to test new teaching-learning techniques

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

Thalidomide tragedy

bull Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women

bull It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children

21

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

bull Within a few years of the widespread use of thalidomide in Europe Australia and Japan approximately 10000 children were born with phocomelia leading to the ban of thalidomide in most countries in 1961

22

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

bull The thalidomide tragedy marked a turning point in toxicity testing as it prompted United States and international regulatory agencies to develop systematic toxicity testing protocols

bull The thalidomide tragedy also brought into sharp focus the importance of rigorous and relevant testing of pharmaceuticals prior to their introduction into the market place (Kelsey 1988)

23

Thalidomide tragedy

Nuremberg Code-1947

bull On April 17 1947 United States Counsel for War Crimescame out with six points defining ldquolegitimate researchrdquo

bull The verdict of August 19 reiterated almost all of thesepoints in a section entitled Permissible MedicalExperiments and revised the original six points into ten

bull Subsequently the ten points became known as theNuremberg Code

24

Codes and Guidelines

Nuremberg Code (1947)

WMArsquos Declaration of Helsinki (1964)

bull Belmont Report (USA) (1979)-Tuskegee syphilis study

Council for International Organizations of Medical Sciences (CIOMS) 1993

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in 1996 Guideline on Good Clinical PracticeE6 (GCP)

Nuremberg Code (1947)

Voluntary and Informed consent-absolutely essential

Anticipate scientific benefits Useful

Animal experimentation first

Avoid physical and mental suffering

Benefits outweigh risks

No intentional death or disability

Protection from harm

Subject free to withdraw

Qualified investigators

Investigator will stop if harm occurs

Nuremberg Code (1947)

Voluntary and Informed consent-absolutely essential

Anticipate scientific benefits Useful

Animal experimentation first

Avoid physical and mental suffering

Benefits outweigh risks

No intentional death or disability

Protection from harm

Subject free to withdraw

Qualified investigators

Investigator will stop if harm occurs

THE DECLARATION OF HELSINKI-1964

Is an international standard for the conduct of clinicalresearch adopted by International Conference onHarmonization(ICH) Good Clinical Practice standards

A global ethical standard for medical research and wasapproved at the WMA General Assembly by a majority voteof 75

It is the mission of the clinical research professionals tosafeguard the health of the people

THE DECLARATION OF HELSINKI-1964

Historical Overview-

Its origin has been found in the Nazi Disaster and hasundergone several modifications

Prior to 1947 Nuremberg Code there was noaccepted code of conduct governing the ethicalaspects of human research

World Medical Association

It is an international organization of physicians

established on September 17 1947

First general Assembly of WMA was held in Paris

France

Mission- Serve humanity by endeavoring to achieve the

highest international standards in medical education

science ethics and health care for all peoples of the world

Declaration of Helsinki 1964

Adapted from Nuremberg

Code by the World Medical Association (WMA)

First adopted in Helsinki Finland 1964

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Is an international standard for the conduct of clinicalresearch adopted by International Conference onHarmonization(ICH) Good Clinical Practice standards

A global ethical standard for medical research and wasapproved at the WMA General Assembly by a majority voteof 75

It is the mission of the clinical research professionals tosafeguard the health of the people

THE DECLARATION OF HELSINKI-1964

Historical Overview-

Its origin has been found in the Nazi Disaster and hasundergone several modifications

Prior to 1947 Nuremberg Code there was noaccepted code of conduct governing the ethicalaspects of human research

World Medical Association

It is an international organization of physicians

established on September 17 1947

First general Assembly of WMA was held in Paris

France

Mission- Serve humanity by endeavoring to achieve the

highest international standards in medical education

science ethics and health care for all peoples of the world

Declaration of Helsinki 1964

Adapted from Nuremberg

Code by the World Medical Association (WMA)

First adopted in Helsinki Finland 1964

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Historical Overview-

Its origin has been found in the Nazi Disaster and hasundergone several modifications

Prior to 1947 Nuremberg Code there was noaccepted code of conduct governing the ethicalaspects of human research

World Medical Association

It is an international organization of physicians

established on September 17 1947

First general Assembly of WMA was held in Paris

France

Mission- Serve humanity by endeavoring to achieve the

highest international standards in medical education

science ethics and health care for all peoples of the world

Declaration of Helsinki 1964

Adapted from Nuremberg

Code by the World Medical Association (WMA)

First adopted in Helsinki Finland 1964

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

World Medical Association

It is an international organization of physicians

established on September 17 1947

First general Assembly of WMA was held in Paris

France

Mission- Serve humanity by endeavoring to achieve the

highest international standards in medical education

science ethics and health care for all peoples of the world

Declaration of Helsinki 1964

Adapted from Nuremberg

Code by the World Medical Association (WMA)

First adopted in Helsinki Finland 1964

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki 1964

Adapted from Nuremberg

Code by the World Medical Association (WMA)

First adopted in Helsinki Finland 1964

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI- 2008

Ethical Principles for Medical Research Involving Human Subjects

Adopted by the 18th WMA General Assembly Helsinki Finland June 1964 and amended by the

29th WMA General Assembly Tokyo Japan October 1975

35th WMA General Assembly Venice Italy October 1983

41st WMA General Assembly Hong Kong September 1989

53th WMA General Assembly Washington 2002 (Note of Clarification on paragraph 29 added)

55th WMA General Assembly Tokyo 2004 (Note of Clarification on Paragraph 30 added)

59th WMA General Assembly Seoul October 2008

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Seven Ethical Pillars of Clinical Research

AUTONOMY

BENEFICENCE

NON ndash MALFEASANCE

FIDELITY

TRUTHFULNESS

CONFIDENTIALITY

JUSTICE

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Autonomy

Consent

Para 20 The subjects must be volunteers andinformed participants in the research project

Para 22 freely-given informed consent

preferably in writing

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 5 well-being of the human subject shouldtake precedence over the interests of scienceand society

Beneficence

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 16

bull Preceded by careful assessment ofpredictable risks and burdens

bull Attempt to avoid any act or treatmentplan that would harm the patient

Non Malfeasance

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 11

Medical research involving human subjects must be basedon generally accepted scientific principles thoroughknowledge of the scientific literature and on adequatelaboratory and where appropriate animalexperimentation

Para 15

Conducted only by clinically competent medical person

Fidelity ndash duty of care

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 27

Both authors amp investigators are obliged topreserve the accuracy of the results Negativeas well as positive results should be published

Truthfulness - Honesty

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 21

Every precaution should be taken torespect the privacy of the subject theconfidentiality of the patients information

Confidentiality

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Declaration of Helsinki

Para 30

Every patient entered into the study should be assured ofaccess to the best proven prophylactic diagnostic andtherapeutic methods identified by the study

Para 9

Research Investigators should be aware of the ethicallegal and regulatory requirements for research on humansubjects

Para 17

Physicians should cease any investigation if the risksoutweigh the potential benefits

Justice

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

DECLARATION OF HELSINKI -Basic Principles

1 Conform to accepted scientific principles

2 Design formulated in experimental protocol reviewed by IEC

3 Conducted by qualified and trained persons

4 Importance in proportion to inherent risk

5 Assessment of risks vs benefits

6 Safeguard subjectrsquos integrity (privacy)

7 Abstain unless hazards are predictable

8 Preserve accuracy when publishing

9 Adequately inform or right to withdraw

10 Obtain true informed consent in writing

11 Reliance on legal guardian

12 State compliance with Declaration

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

bull Tuskegee Syphilis Study (1932ndash1972)

bull Named the Belmont Report for the Belmont Conference Center where the National Commission met when first drafting the report

42

Belmont Report 1979

Belmont Report 1979

Three ethical principles related to research on human subjects

1 Respect for Persons

2 Beneficence Do no harm while maximizing benefits for research project and minimizing risks to the research subjects

3 Justice ensuring reasonable non-exploitative and well-considered procedures are administered

Overview of

ICH GCP

What is ICH

bull The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)- is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe Japan and the US to discuss scientific and technical aspects of drug registration

45

What is ICH

bull Since its inception in 1990 ICH has

gradually evolved

bull ICHs mission is to ensure that safe

effective and high quality medicines are

developed and registered in the most

resource-efficient manner

How did it evolve

The need to harmonize

bull Public disasters serious fraud and abuse of human rights

bull Trials of War criminals-Nuremberg code 1949

bull Thalidomide- Declaration of Helsinki 1964

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Overview of

ICH GCP

What is ICH

bull The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)- is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe Japan and the US to discuss scientific and technical aspects of drug registration

45

What is ICH

bull Since its inception in 1990 ICH has

gradually evolved

bull ICHs mission is to ensure that safe

effective and high quality medicines are

developed and registered in the most

resource-efficient manner

How did it evolve

The need to harmonize

bull Public disasters serious fraud and abuse of human rights

bull Trials of War criminals-Nuremberg code 1949

bull Thalidomide- Declaration of Helsinki 1964

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

What is ICH

bull The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)- is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe Japan and the US to discuss scientific and technical aspects of drug registration

45

What is ICH

bull Since its inception in 1990 ICH has

gradually evolved

bull ICHs mission is to ensure that safe

effective and high quality medicines are

developed and registered in the most

resource-efficient manner

How did it evolve

The need to harmonize

bull Public disasters serious fraud and abuse of human rights

bull Trials of War criminals-Nuremberg code 1949

bull Thalidomide- Declaration of Helsinki 1964

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

What is ICH

bull Since its inception in 1990 ICH has

gradually evolved

bull ICHs mission is to ensure that safe

effective and high quality medicines are

developed and registered in the most

resource-efficient manner

How did it evolve

The need to harmonize

bull Public disasters serious fraud and abuse of human rights

bull Trials of War criminals-Nuremberg code 1949

bull Thalidomide- Declaration of Helsinki 1964

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

How did it evolve

The need to harmonize

bull Public disasters serious fraud and abuse of human rights

bull Trials of War criminals-Nuremberg code 1949

bull Thalidomide- Declaration of Helsinki 1964

bull Belmont report 1978 (Ethical Principles and guidelines for the protection of human subjects of research)-Tuskegee syphilis study

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

History

1962 US FDA IND Guidelines

1964 Declaration of Helsinki

1968 Committee on Safety of Medicines uk

1978 GCP US FDA

1991 GCP Europe

1996 ICH GCP

1997 ICH GCP Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

When did it begin

bull Ist conf in 1990 in Brussels

3 regions participated

bull Representatives from

Industry

Academia

Ministry of

health

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

ICH parties

6 parties

bull EU bull EFPIA European federation of pharmaceutical industriesrsquo associations

bull MHLW Ministry of health Labor and welfare Japan

bull JPMA Japan Pharmaceuticals manufacturers Association

bull US FDA

bull PhRMA

bull Observers WHO TPP(canada)

bull International federation of Pharmaceutical manufacturerrsquos association

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Key objective

bull To discuss and define the minimum standards for the development and registration of investigational products

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

The result

Many guidelines made

bull Most important- ICH GCP guidelines

bull Evolved in several steps

bull Consolidated guideline ICH E6 Sept 1997

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

ICH Guidelines examples

bull Efficacy ndash clinical trials etc

bull Safety ndash pharmacovigilance adverse drug reaction

reporting

bull Quality ndash raw materials impurities residual solvents etc

bull Multidisciplinary ndash common technical document electronic

submission coding systems

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

What is GCP

A standard for the design conduct performance monitoring auditing recording analyses and reporting of clinical trials that provide assurance that the data and the reported results are credible accurate and that the rights integrity and confidentiality of trial subjects are protected

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Why is it needed

bull To ensure the rights safety and well being of the trial subjects are protected

bull Ensure the credibility of clinical trial data

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

The ICH GCP guideline

bull Provide a unified standard for the EU Japan and USA regions to facilitate mutual acceptance of clinical trial data by the regulatory authorities in

these regions

bull 8 sections

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

ICH GCP guideline

1 Glossary

Common language for investigatorssponsorsethics committees

2Principles of Good Clinical Practice

13 tenets of ICH GCP

3Requirements for IRBIEC

Roles responsibilities and composition

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

ICH GCP guideline

4Responsibilities of the investigator

5Responsibilities of the sponsor

6Requirements for clinical trial protocol and protocol amendments

7Responsibility of the sponsor in the development of investigatorrsquos brochure

8Essential documents

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Ethical conduct as per

Declaration of Helsinki

GCP

Regulatory Requirements

Risk- Benefit

Primary concern- Subject

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Supportive data

bull Protocol

Scientifically sound clear detailed

bull Ethical Clearance

Study to be conducted in compliance to the protocol which has received EC approval

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Subject Care

Medical decisions responsibility of qualified physician

bull Qualified staff

By education training experience in their area of responsibility

bull Informed Consent

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Clinical Trial data

Recorded handled and stored to enable accurate reporting interpretation and verification

bull Confidentiality

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Investigational Product

Manufactured handled and stored as per GMP

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Principles of ICH GCP

bull Quality Assurance

Systems and procedures to ensure the Quality of every aspect of the trial

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Indian GCP guidelines

bull Released in Dec 2001(Developed by CDCSO and endorsed by DCGI)

bull In general in line with ICH GCP

bull Has Revised Schedule Y (Jan 2005) addressed discrepancies

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

bull SAFEGUARD PUBLIC HEALTH

bull ASSURE CONSUMER PROTECTION STANDARDS

bull FACILITATE AVAILABILITY OF SAFE AND EFFECTIVE PRODUCTS

bull ELIMINATE INCONSISTENT STANDARDS INTERNATIONALLY

bull FACILITATE MUTUAL ACCEPTANCE OF DATA FROM CLINICAL TRIALS

GOALS OF INTERNATIONAL HARMONIZATION OF

REGULATORY REQUIREMENTS

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Study DocumentationDuring the study

The investigator must keepndash Source documents

bull Medical records (including access to computer records)

bull Laboratory reports

bull ECGs X-rays etc

bull Any other medical records reports or notes (hospital admissions and discharges)

ndash A subject identification list

ndash Copies of all study related documentation

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Medical Records

bull In particular they should contain notes on

ndash Sufficient information to support subject eligibility

ndash This should be well documented (signed and dated)

ndash Subjectrsquos participation in the study

ndash Dates of visits

ndash Procedures investigations done

ndash Observations diagnoses

ndash Medications taken (including study medication)

ndash Adverse events

ndash Completion or withdrawal (reason) from the study

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Study DocumentationAfter the study

The sponsor needs from the investigator

ndash Final drug accountability records

ndash All used and unused supplies and medication

ndash All required documents completed

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

Conclusion

70

Thanks

ldquoWhen a doctor [goes] wrong he is

the first of criminals He has nerve

and he has knowledgerdquo

- Sherlock Holmes

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline

References

httpwwwwmanetepolicyb3htm

wwwhhsgovohrphumansubjectsguidancebelmonthtml

wwwhhsgovohrpreferencesnurcodehtml

wwwicmrnicinguidelinesGCLP

wwwcdsconicin

wwwubedurecercaBioeticadocDeclaracio_Helsinki_2013

wwwjewishvirtuallibraryorgjsourceHolocaustnazi_experiments

wwwichorgfileadminPublic_WebICHE6_R1__Guideline