11 “So You Think You Know GCP...” Professional Development Session S049 Sunday, 15 April 2012.

11

“So You Think You Know GCP ...”

Professional Development Session S049

Sunday, 15 April 2012

22

Presenters

• Jill Matzat, RN, BSN, CCRA– President, Medical Research

Management, Inc. and CRA Solutions, Inc.

• Paul Below, MS, CCRA– Contract Clinical Project Leader, American

Medical Systems, Inc.– Principal, P. Below Consulting, Inc.

and GCP Training Specialists

, CCRT

, CCRT

33

Disclosure

• Neither Jill nor Paul have a relevant financial relationship in relation to this educational activity

4

Background

• This presentation was developed to correct numerous errors and myths about Good Clinical Practice overheard by the presenters throughout their clinicalresearch careers

55

Are you sure this Are you sure this is right? I’ve is right? I’ve

never been asked never been asked to document it to document it

this way before.this way before.

Are you sure this Are you sure this is right? I’ve is right? I’ve

never been asked never been asked to document it to document it

this way before.this way before.

Yes, you have to do Yes, you have to do it this way. It’s an it this way. It’s an FDA requirement.FDA requirement.

Yes, you have to do Yes, you have to do it this way. It’s an it this way. It’s an FDA requirement.FDA requirement.

5

66

I never heard of this FDA I never heard of this FDA requirement before but it requirement before but it

must be true. He is the must be true. He is the monitor and he should monitor and he should

know …know …

I never heard of this FDA I never heard of this FDA requirement before but it requirement before but it

must be true. He is the must be true. He is the monitor and he should monitor and he should

know …know …

I wouldn’t I wouldn’t count on itcount on itI wouldn’t I wouldn’t count on itcount on it

6

77

Learning Objectives

• Define Good Clinical Practice (GCP)

• Differentiate between GCP requirements (stated in regulation) and recommendations (stated in guidance documents) in several key areas

• Identify several circumstances where “industry best practices” exist that go above and beyond what the FDA requires or even recommends

8

What is Good Clinical Practice (GCP)?

• Good Clinical Practice (GCP) is a unified standard for designing, conducting, recording, and reporting trials that involve human subjects

• GCP is composed of many parts that cannot be foundin any one book or place

99

Sample TitleSample Text

9

GCP

Other Federal Regulations

FDA Regulations(21 CFR)

State Law

Local Law (Institutional

and IRB Policies)

FDA GuidanceDocuments

InternationalStandards

Sponsor SOPs

IndustryBest Practices

1010


10

GCP


State Law


and IRB Policies)



Sponsor SOPs


• Informed Consent (21 CFR 50)• Institutional review boards (21 CFR 56)• Financial disclosure (21 CFR 54)• Electronics records and signatures (21 CFR 11)• Investigational new drugs (21 CFR 312) and application to

market a new drug (21 CFR 314)• Investigational device exemptions (21 CFR 812) & premarket

approval of medical devices (21 CFR 814)

• Informed Consent (21 CFR 50)• Institutional review boards (21 CFR 56)• Financial disclosure (21 CFR 54)• Electronics records and signatures (21 CFR 11)• Investigational new drugs (21 CFR 312) and application to

market a new drug (21 CFR 314)• Investigational device exemptions (21 CFR 812) & premarket

approval of medical devices (21 CFR 814)


1111


11

GCPState Law


and IRB Policies)



Sponsor SOPs



• Nuclear Regulatory Commission regulations for the medical use of radioactive substances (10 CFR 35 and 21 CFR 361)

• Department of Transportation regulations for the shipment of hazardous materials (49 CFR)

• HIPAA Privacy Rule (45 CFR 160-164) for the use and disclosure of protected health information

• “Common Rule” (45 CFR 46) - Human subjects protection rules for federally funded research

• Nuclear Regulatory Commission regulations for the medical use of radioactive substances (10 CFR 35 and 21 CFR 361)

• Department of Transportation regulations for the shipment of hazardous materials (49 CFR)

• HIPAA Privacy Rule (45 CFR 160-164) for the use and disclosure of protected health information

• “Common Rule” (45 CFR 46) - Human subjects protection rules for federally funded research

Other FederalRegulations

1212


12

GCP


State Law


and IRB Policies)


Sponsor SOPs



• FDA Information Sheets

• ICH Guidelines for Good Clinical Practice (1997)

• Investigator Responsibilities (2009)

• Adverse Event Reporting to IRBs (2009)

• FAQs on the Form FDA 1572 (2010)

• Risk-Based Approach to Monitoring (Draft, 2011)

• FDA Information Sheets

• ICH Guidelines for Good Clinical Practice (1997)

• Investigator Responsibilities (2009)

• Adverse Event Reporting to IRBs (2009)

• FAQs on the Form FDA 1572 (2010)

• Risk-Based Approach to Monitoring (Draft, 2011)


1313


13

GCP


State Law


and IRB Policies)


Sponsor SOPs



• Ethical Doctrines: Declaration of Helsinki Nuremberg Code

• Clinical Research Guidelines: ICH Guidelines for GCP (E6) ICH Guidelines for Safety Reporting (E2A) ISO 14155 – Medical Devices

• EU Directives

• Country-Specific Requirements

• Ethical Doctrines: Declaration of Helsinki Nuremberg Code

• Clinical Research Guidelines: ICH Guidelines for GCP (E6) ICH Guidelines for Safety Reporting (E2A) ISO 14155 – Medical Devices

• EU Directives

• Country-Specific Requirements


1414


14

GCP



and IRB Policies)



Sponsor SOPs


FDA Regulations(21 CFR) • Age of consent

• Legally authorized representatives

• Clinical research registration

• Medical records privacy

• Gene research

• STD/HIV reporting

• Gifts to practitioners

• Age of consent

• Legally authorized representatives

• Clinical research registration

• Medical records privacy

• Gene research

• STD/HIV reporting

• Gifts to practitioners

State Laws

151515

GCP


State Law



Sponsor SOPs



• Institutional Policies: Internal Protocol Review Committee Approval Investigational Product Storage / Dispensing Personnel Training Requirements

• IRB Policies: Protocol Deviation Reporting Requirements SAE Reporting Requirements Frequency of Continuing Review and Reporting Format Informed Consent Requirements

• Institutional Policies: Internal Protocol Review Committee Approval Investigational Product Storage / Dispensing Personnel Training Requirements

• IRB Policies: Protocol Deviation Reporting Requirements SAE Reporting Requirements Frequency of Continuing Review and Reporting Format Informed Consent Requirements


and IRB Policies)

1616


16

GCP


State Law


and IRB Policies)





• CRF Completion Guidelines

• SAE Reporting Requirements

• Regulatory Document Organization

• Sponsor-Specific Form Completion

• Source Documentation Practices

• Investigator Signature Requirements

• Investigational Product Storage and Accountability Requirements

• CRF Completion Guidelines

• SAE Reporting Requirements

• Regulatory Document Organization

• Sponsor-Specific Form Completion

• Source Documentation Practices

• Investigator Signature Requirements

• Investigational Product Storage and Accountability Requirements

SponsorSOPs

1717

Sample Text

17

GCP


State Law


and IRB Policies)



Sponsor SOPs


• Good Documentation Practices

• GCP Training Requirements

• Site SAE Reporting Requirements

• Investigational Product Storage

• Handling Lost to Follow-Up Subjects

• Curriculum Vitae Requirements

• Form 1572 and Clinical Investigator Agreement Requirements

• Good Documentation Practices

• GCP Training Requirements

• Site SAE Reporting Requirements

• Investigational Product Storage

• Handling Lost to Follow-Up Subjects

• Curriculum Vitae Requirements

• Form 1572 and Clinical Investigator Agreement Requirements


1818


18

GCP



State Law


and IRB Policies)



Sponsor SOPs


191919

Learning all of the parts of GCP can take some time and may seem daunting to those new to the

clinical research industry

2020

Time to Test Your GCP Knowledge

2121

• The following slides are a series of questions to test your knowledge of GCP

• You will be able to submit your answers by text messaging orthrough the web

• All answers areanonymous (no oneis identified by name or phone number)

21

2222

How to Vote by Text Message

Example Question: What is your favorite color?

• Red (72612)

• Blue (72613)

• Green (72614)

• Orange (72615)

To vote, text the corresponding keyword to 22333 NOTE: Standard carrier text messaging rates apply but there are no additional fees to participate in the quiz

2323

How to Vote Through the Web

Example Question: What is your favorite color?

• Red

• Blue

• Green

• Orange

To vote, go to:PollEv.com/ACRP2012

NOTE: Standard carrier data usage charges apply but there are no additional fees to participate in the quiz

2424

Informed Consent

Questions

2525

FDA Regulations (21 CFR 50) specify the following:

Question Keyword

The ICF must be signed and dated by the subject 118968

The ICF must be signed and dated by the person obtaining consent

118969

The ICF must be signed and dated by the Principal Investigator 118970

The ICF must be signed by a child subject if the IRB determines that assent is required

118972

All of the above 118973

Question

25

2626


Question Keyword



118969



118972


Text your answer (keyword) to 22333 or go to PollEv.com/ACRP2012 to vote

Question

26

2727

Poll Results

2828


Question Keyword



118969



118972


Specified in 21 CFR 50.27aSpecified in 21 CFR 50.27a

Answer

28

2929

• The ICF must be signed and dated by the person obtaining consent – Specified by ICH GCP (4.8.8).

• The ICF must be signed and dated by the Principal Investigator – Not specified by FDA Regulation or Guidance but sometimes required by IRBs.

• The ICF must be signed by a child subject if the IRB determines that assent is required – The method of documenting assent is determined by the IRB (21 CFR 50.55) and does not necessarily have to be by child signature.

Explanation

3030

FDA Guidance (Guide to Informed Consent Info Sheet & ICH GCP) specifies the following:

Question Keyword

The ICF should be written at a 6th grade reading level 41600

When it is anticipated that consent interviews will be conducted in a foreign language, a translated ICF should be prepared

41604

A subject who can understand and comprehend spoken English, but is physically unable to talk or write, should not be enrolled in a clinical trial

41704

All study personnel involved in the informed consent process should be trained in Human Subjects Protection

41740


Question

3131

Poll Results

3232

FDA Guidance (Guide to Informed Consent Info Sheet & ICH GCP) specifies the following:

Question Keyword

The ICF should be written at a 6th grade reading level 41600

When it is anticipated that consent interviews will be conducted in a foreign language, a translated ICF should be prepared

41604

A subject who can understand and comprehend spoken English, but is physically unable to talk or write, should not be enrolled in a clinical trial

41704

All study personnel involved in the informed consent process should be trained in Human Subjects Protection

41740


Answer

32

However, the Guide to Informed Consent indicates that if a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the ICF and must rely on oral translation.

However, the Guide to Informed Consent indicates that if a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the ICF and must rely on oral translation.

3333

• The ICF should be written at a 6th grade reading level – No specific grade level requirement is defined. Instead, the FDA Information Sheets say:

“The IRB should ensure that technical and scientific terms are adequately explained or that common terms are substituted. The IRB should ensure that the informed consent document properly translates complex scientific concepts into simple concepts that the typical subject can read and comprehend.”

Similarly, ICH (4.8.6) specifies that the consent language should be “as non-technical as practical and should be understandable to the subject.”

Explanation

33

3434

• A subject who can understand and comprehend spoken English, but is physically unable to talk or write, should not be enrolled in a clinical trial – They can be enrolled if an impartial witness is present during the entire informed consent discussion.

• All study personnel involved in the informed consent process should be trained in Human Subjects Protection – Required for NIH studies but not currently specified by FDA.

Explanation

34

3535

Financial DisclosureQuestion

3636


Question Keyword

Part- or full-time employees of the sponsor may not participate as Clinical Investigators in that sponsor’s trials

47817

Clinical Investigators may not have a proprietary interest (i.e., patents, royalties) in the tested product in a trial

47914

Clinical Investigators may not receive more than $25,000 a year in “payments of other sorts” (i.e., grants, consulting fees, speaker honoraria)

47915

In general, financial disclosure is not required for large open safety studies conducted at multiple sites

48364

None of the above 48393

Question

36

3737

Poll Results

3838


Question Keyword

Part- or full-time employees of the sponsor may not participate as Clinical Investigators in that sponsor’s trials

47817

Clinical Investigators may not have a proprietary interest (i.e., patents, royalties) in the tested product in a trial

47914

Clinical Investigators may not receive more than $25,000 a year in “payments of other sorts” (i.e., grants, consulting fees, speaker honoraria)

47915

In general, financial disclosure is not required for large open safety studies conducted at multiple sites

48364


Answer

Specified in 21 CFR 54.2e. Financial disclosure applies to any study of a drug or device in humans submitted in a marketing application that the applicant or FDA relies on to establish efficacy or any study in which a single investigator makes a significant contribution to the demonstration of safety.

Specified in 21 CFR 54.2e. Financial disclosure applies to any study of a drug or device in humans submitted in a marketing application that the applicant or FDA relies on to establish efficacy or any study in which a single investigator makes a significant contribution to the demonstration of safety.

38

3939

• Part- or full-time employees of the sponsor may not participate as Clinical Investigators in that sponsor’s trials – This is allowed but financial disclosure is required.

• Clinical Investigators may not have a proprietary interest (i.e., patents, royalties) in the tested product in a trial – Same as above.

• Clinical Investigators may not receive more than $25,000 a year in “payments of other sorts” (i.e., grants, consulting fees, speaker honoraria) – Same as above.

Explanation

39

4040

• Sponsors may include individuals as Investigators who have these financial interests but they have to explain any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments (21 CFR 54.4a)

• FDA then decides if the steps are adequate to ensure the reliability of the study (21 CFR 54.5a)

• Interestingly, there is no requirement for financial disclosure by monitors or other sponsor personnel who have the capacity to bias the data

Explanation

40

4141

IRBQuestion

4242


Question Keyword

An IRB must be composed of five (5) members 9820

An IRB must have at least one female member 9855

If an IRB regularly reviews research involving prisoners, a prisoner representative should be included on the board

9858

An IRB member that has a conflicting interest in a project under review may not participate in the IRB's review proceedings

10017


Question

42

4343

Poll Results

4444


Question Keyword

An IRB must be composed of five (5) members 9820

An IRB must have at least one female member 9855

If an IRB regularly reviews research involving prisoners, a prisoner representative should be included on the board

9858

An IRB member that has a conflicting interest in a project under review may not participate in the IRB's review proceedings

10017


Answer

44

4545

• An IRB must be composed of five (5) members – Must have at least 5 members (21 CFR 56.107a).

• An IRB must have at least one female member – The FDA Regulations (21 CFR 56.107b) specify:

“Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender.”

Explanation

45

4646

• If an IRB regularly reviews research involving prisoners, a prisoner representative should be included on the board – Consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with those subjects (21 CFR 56.107a).

• An IRB member that has a conflicting interest in a project under review may not participate in the IRB's review proceedings – These individuals can participate in order to provide information requested by the IRB (21 CFR 56.107e).

Explanation

46

4747

MonitoringQuestion

4848

FDA Guidance (ICH GCP) specifies the following:

Question Keyword

A monitoring report should be submitted to the sponsor after each site visit or trial-related communication

92521

Monitors should not make any notations or corrections on the CRF pages

93121

Monitors should ensure that all corrections to the CRF are completed with a single line through the incorrect entry and initiated and dated by the completer

93342

Monitors should attempt to meet in person with the Investigator at every visit to discuss the progress of the trial

93345


Question

48

4949

Poll Results

5050

FDA Guidance (ICH GCP) specifies the following:

Question Keyword

A monitoring report should be submitted to the sponsor after each site visit or trial-related communication

92521

Monitors should not make any notations or corrections on the CRF pages

93121

Monitors should ensure that all corrections to the CRF are completed with a single line through the entry and are initiated and dated by the completer

93342

Monitors should attempt to meet in person with the Investigator at every visit to discuss the progress of the trial

93345


Answer

Specified in ICH 5.18.6aSpecified in ICH 5.18.6a

50

5151

• Monitors should not make any notations or corrections on the CRF pages – Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator (ICH 4.9.3).

• Monitors should ensure that all corrections to the CRF are completed with a single line through the entry and are initiated and dated by the completer – Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (ICH 4.9.3).

Explanation

51

5252

• Monitors should attempt to meet in person with the Investigator at every visit to discuss the progress of the trial – There are several sections of ICH that address the monitors responsibility to communicate with the Investigator but the frequency of these communications is not specified (ICH 5.18.4). This is often specified in sponsor SOPs.

Explanation

52

5353

SourceDocumentation

Question

5454

FDA Regulations (21 CFR 312/812) specify the following:

Question Keyword

It is prohibited to use CRFs (other than questionnaires) directly as source documents

186220

Each subject’s case history should document that informed consent was obtained prior to participation in the study

186239

All source documents must be signed by the completer 186240

If a site uses electronic medical records as source documents, the EMR system must be compliant with 21 CFR part 11

186241


Question

54

5555

Poll Results

5656

FDA Regulations (21 CFR 312/812) specify the following:

Question Keyword

It is prohibited to use CRFs (other than questionnaires) directly as source documents

186220

Each subject’s case history should document that informed consent was obtained prior to participation in the study

186239

All source documents must be signed by the completer 186240

If a site uses electronic medical records as source documents, the EMR system must be compliant with 21 CFR part 11

186241


Answer

56

Specified in both 21 CFR 312.62b and 812.140a. “Case histories” include CRFs, signed and dated consent forms, and medical records (physician progress notes, individual's hospital chart and the nursing notes)

Specified in both 21 CFR 312.62b and 812.140a. “Case histories” include CRFs, signed and dated consent forms, and medical records (physician progress notes, individual's hospital chart and the nursing notes)

5757

• It is prohibited to use CRFs (other than questionnaires) directly as source documents – There is no regulation preventing this practice or from using copies of CRFs as source documents.

• All source documents must be signed by the completer – There is no requirement for this but several FDA Guidances do specify that data should be “attributable.”

Explanation

57

5858

• If a site uses electronic medical records as source documents, the EMR system must be compliant with 21 CFR part 11 – There is currently no FDA Regulation or Guidance specifying this. However, a recent FDA Draft Guidance does indicate:

“For those who use electronic signatures based upon the use of identification codes in combination with passwords, the clinical site must employ controls to ensure the security and integrity of the authorized user names and passwords (21 CFR 11.300a).” Draft Guidance on Electronic Source Documentation in Clinical Investigations (December 2010)

Explanation

58

5959

InvestigatorResponsibilities

Question

6060

FDA Guidance specifies the following:Question Keyword

A Trial Delegation List should identify the training that individuals have received that qualifies them to perform delegated tasks

187191

In device studies, the field clinical engineer’s activities should be described in the protocol and informed consent (if face-to-face contact with subjects)

187193

Investigators should develop a plan for the oversight of the clinical trial that might include the creation of specific SOPs

187214

Investigators conducting studies of drugs with potentially fatal toxicity should be readily available 24 hours/day and in reasonably close proximity to study subjects

187219


Question

60

6161

Poll Results

6262

FDA Guidance specifies the following:Question Keyword

A Trial Delegation List should identify the training that individuals have received that qualifies them to perform delegated tasks

187191

In device studies, the field clinical engineer’s activities should be described in the protocol and informed consent (if face-to-face contact with subjects)

187193

Investigators should develop a plan for the oversight of the clinical trial that might include the creation of specific SOPs

187214

Investigators conducting studies of drugs with potentially fatal toxicity should be readily available 24 hours/day and in reasonably close proximity to study subjects

187219


Answer

62

6363

Study Records Storage

Question

6464

FDA Regulations (21 CFR 312/812) and Guidance (ICH GCP) specify the following:

Question Keyword

It is the Investigator’s responsibility to inquire with the sponsor when study records no longer need to be retained

187650

In general, study records should be obtained indefinitely because it is never certain when product development will be permanently discontinued by the sponsor

187653

Sponsors should pay for the costs of records storage by Investigators

187671

For device studies, an Investigator may transfer custody of study records to anyone who will accept responsibility for them

187672


Question

64

6565

Poll Results

6666

FDA Regulations (21 CFR 312/812) and Guidance (ICH GCP) specify the following:

Question Keyword

It is the Investigator’s responsibility to inquire with the sponsor when study records no longer need to be retained

187650

In general, study records should be obtained indefinitely because it is never certain when product development will be permanently discontinued by the sponsor

187653

Sponsors should pay for the costs of records storage by Investigators

187671

For device studies, an Investigator may transfer custody of study records to anyone who will accept responsibility for them

187672


Answer

66

Specified in 21 CFR 812.140e (however, there is no comparable language in Part 312)Specified in 21 CFR 812.140e (however, there is no comparable language in Part 312)

6767

• It is the Investigator’s responsibility to inquire with the sponsor when study records no longer need to be retained – Per ICH 4.9.5, it is sponsor’s responsibility to do so. In addition, ICH 5.5.12, indicates:

“The sponsor should inform the investigators/ institutions in writing of the need for record retention and should notify the investigators/institutions in writing when the trial related records are no longer needed.”

Explanation

67

6868

• In general, study records should be obtained indefinitely because it is never certain when product development will be permanently discontinued by the sponsor – The FDA Regulations and ICH GCP both have criteria for retention that are well defined. The current reality is that sites and sponsors usually plan to hold onto records for many decades.

Explanation

68

6969

• Sponsors should pay for the costs of records storage by Investigators – There is no FDA Regulation or Guidance that address this but many experienced sites now demand this as a line item in their Clinical Trial Agreements.

Explanation

69

70

In Conclusion

That doesn’t sound That doesn’t sound right to me. Where right to me. Where

exactly is that listed in exactly is that listed in the CFR?the CFR?

That doesn’t sound That doesn’t sound right to me. Where right to me. Where

exactly is that listed in exactly is that listed in the CFR?the CFR?

Yes, you have to Yes, you have to do it this way. do it this way. It’s It’s

an FDA an FDA requirementrequirement..

Yes, you have to Yes, you have to do it this way. do it this way. It’s It’s

an FDA an FDA requirementrequirement..

71

In Conclusion

Well, uh …Well, uh …OK, maybe it’s not a OK, maybe it’s not a

regulation but it’s regulation but it’s what the FDA what the FDA

expects.expects.

Well, uh …Well, uh …OK, maybe it’s not a OK, maybe it’s not a

regulation but it’s regulation but it’s what the FDA what the FDA

expects.expects.

That still doesn’t That still doesn’t sound right. What sound right. What

guidance document guidance document is that from?is that from?

That still doesn’t That still doesn’t sound right. What sound right. What

guidance document guidance document is that from?is that from?

72

In Conclusion

I’m not sure but it I’m not sure but it doesn’t matter. It’s doesn’t matter. It’s a requirement of my a requirement of my

sponsor company.sponsor company.

I’m not sure but it I’m not sure but it doesn’t matter. It’s doesn’t matter. It’s a requirement of my a requirement of my

sponsor company.sponsor company.

73

In Conclusion

OK, that’s fine. Why didn’t you just say so in OK, that’s fine. Why didn’t you just say so in the first place? I’m happy to do it to satisfy the first place? I’m happy to do it to satisfy your company policy. You didn’t have to your company policy. You didn’t have to

use those FDA excuses to justify your use those FDA excuses to justify your request.request.

OK, that’s fine. Why didn’t you just say so in OK, that’s fine. Why didn’t you just say so in the first place? I’m happy to do it to satisfy the first place? I’m happy to do it to satisfy your company policy. You didn’t have to your company policy. You didn’t have to

use those FDA excuses to justify your use those FDA excuses to justify your request.request.

7474

Learning Objectives

• Define Good Clinical Practice (GCP)

• Differentiate between GCP requirements (stated in regulation) and recommendations (stated in guidance documents) in several key areas

• Identify several circumstances where “industry best practices” exist that go above and beyond what the FDA requires or even recommends

7575

Closing Thoughts

• Much of what we do in clinical research is driven by our own industry best practices and not by FDA requirements or even recommendations

• It takes a serious effort to understand all of the component parts of GCP and to stay up-to-date with changes

• As sponsor representatives, we often act as trainers for new site staff and they rely on us to provide accurate information

7676

Closing Thoughts

• Be careful when telling an investigator site, “You have to do this because the FDA requires it” unless you are certain that it is specified by regulation – it can seem like a very heavy handed play if you are wrong

“The

FDA re

quire

s it”

The F

DA requ

ires i

t”Compliance Toolbox

7777

Your Chance to Ask Us Questions

7878

• Jill Matzat, RN, BSN, [email protected]

• Paul Below, [email protected]

• Complete poll results are available at:www.pbelow-consulting.com/gcp.html

78

You are welcome to use these slides for your own internal training purposes but they remain the copyrighted property of the presenters. Please contact Paul or Jill for permission to reuse.

79

Thank You!

11 “So You Think You Know GCP...” Professional Development Session S049 Sunday, 15 April 2012.

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Transcript of 11 “So You Think You Know GCP...” Professional Development Session S049 Sunday, 15 April 2012.