Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12
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Transcript of Sandra Maddock & Brandy Smith BioEnterprise Presentation 9.6.12
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We have studied clinical research and
regulatory compliance issues since 1999.
The Difference is in the Details
Drugs vs. DevicesPresented by:
Brandy SmithSandra Maddock
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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Articles recognized in the official US Pharmacopoeia, official Homoeopathic Pharmacopoeia of the US, or official National Formulary
• intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
• intended to affect the structure of any function of the body
(FDC Act, Section 201)
Overview of Drugs and DevicesDrugs
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An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article… which is –
• intended for use in the diagnosis of disease… in cure, mitigation, treatment, or prevention of disease
• intended to affect the structure of any function of the body… not achieved through chemical action… or being metabolized
(FDC Act, Section 201)
Overview of Drugs and DevicesDevices
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Class Description
Class I Least risky, general controls adequate; no clinical trial needed
Class II Intermediate risk, special controls needed (510k)
Class III Substantial risk devices, pre-market approval needed (IDE)
Overview of Drugs and DevicesDevice classifications
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Drugs
Chemical/ metabolic action
Distributed systemically
May impact metabolism of other drugs
Larger number of study subjects needed to identify side effects
Clinical Trial Always Required
Devices
Not metabolized
Acts locally
Effects structure
Smaller number of study subjects needed
Clinical trial needs are based on risk classification of device
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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• In situations of a drug, a clinical trial will always be required
• However, not all devices will need to undergo a clinical trial
• The determination of whether or not a device clinical trial is required is based on a risk stratification
Determining the Need for a Clinical Trial
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Drugs
21 CFR 312“IND”
All Drugs require Clinical Trials
Devices
Intermediate Risk
Clinical trial MAY be required
Substantial Risk
Clinical Trial Required
Assess Risk Classification
Determining the Need for a Clinical Trial
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Devices
Intermediate Risk
Clinical trial MAY be required
Substantial Risk
Clinical Trial Required
Assess Risk Classification
Determining the Need for a Clinical Trial
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Class Description
Class I Least risky, general controls adequate; no clinical trial needed
Class II Intermediate risk, special controls needed (510k)
Class III Substantial risk devices, pre-market approval needed (IDE)
}Minima
l RiskIntermediat
e RiskSubstantial
Risk
No Clinical
Trial Required
MAY Require Clinical
Trial
REQUIRES Clinical
Trial
Risk Classification
Determining the Need for a Clinical TrialRisk Stratification
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Class Description
Class I Least risky, general controls adequate; no clinical trial needed
Class II Intermediate risk, special controls needed (510k)
Class III Substantial risk devices, pre-market approval needed (IDE)
}Minima
l RiskIntermediat
e RiskSubstantial
Risk
No Clinical
Trial Required
MAY Require Clinical
Trial
REQUIRES Clinical
Trial
Risk Classification
Determining the Need for a Clinical TrialRisk Stratification
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Drugs
21 CFR 312“IND”
All Drugs require Clinical Trials
Devices
Intermediate Risk
Clinical trial MAY be required
Substantial Risk
Clinical Trial Required
Assess Risk Classification
Determining the Need for a Clinical TrialRisk Stratification
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Drugs
21 CFR 312“IND”
All Drugs require Clinical Trials
*Clinical Trials Always Required for New Drugs*
Determining the Need for a Clinical TrialRisk Stratification
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Clinical TrialsDrugs
Phase PurposePhase I Normal healthy volunteers
Determine metabolism and pharmacologic actionsAim= safety and tolerance
Phase II Patients with the disease or conditionSmall SampleAim= safety and effectiveness
Phase III Patients with the disease or conditionLARGER populationAim= safety and effectiveness
Phase IV Post approval studiesObtain additional information regarding risks, benefits, and optimal use
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Clinical TrialsDevices
Study PurposeAlthough there are “phases” in device research, they are not as delineated as drugsPilot May conduct pilot study (strategic decision or FDA request)
Single-center or small number of multi-center sitesSmall number of subjectsSafety and tolerance
Pivotal Larger number of subjectsLarger number of sitesSafety and effectiveness
Continued Access
During PMA review of pivotal data, the FDA may grant continued use of the device and allow more subjects to be enrolled
Post Market Strategic decision or FDA’s requestMethod to collect long-term data
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Feature Drug DeviceRate of technology change Low HighInfluence of physician technique Low HighPopulation size Large SmallAble to visualize performance Low HighAbility to blind treatments Easy DifficultUse of randomization High LowPhases Clear Less Clear
(pilot/pivotal)
Clinical TrialsDrugs and Devices
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 21CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; SPONSOR AND SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;IRB SOPs; It’s Complicated!
Sponsor
Sponsor Requirements
Good Clinical Practice
FDA Regulations
ICH Guidelines
Protocol RequirementsInvestigator
Agreements
ISO14155
NIH Guidelines
IRB Requirements
Internal Policies
CRO/Monitor
Research Site
Regulatory OverviewWhat you need to know
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Sponsor
FDA Regulations
Research Site
• Investigator(s)• Research Coordinator(s)• Other Research Administration• Institutional Review Board (IRBs)
CRO/Monitor
Regulatory OverviewOur Focus
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• Requirements for conducting clinical studies
• Outlines responsibilities of the sponsors, investigators, and IRBs for conducting trials involving human subjects
Regulatory OverviewCode of Federal Regulations
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Titles
Chapters
Parts
Subparts
Paragraphs
Sections
Regulatory OverviewCode of Federal Regulations
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Title: CRF Title 21
Chapter: Food and Drugs
Part: 50 Protection of Human Subjects
Subpart: B Informed Consent of Human Subjects
Section: (a) – Basic Elements of Informed Consent
Section Paragraph: (1) Statement that the study involves research…
Regulatory OverviewCode of Federal Regulations
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Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial DisclosuresPart: 11 Electronic Records/Electronic Signatures
Regulatory OverviewCode of Federal Regulations
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Minute to Win It!
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Fill in the blanks….Regarding record maintenance, an investigator must maintain accurate, complete and current records, including:
21 CFR 812.140 (1)All _____________ with another ____________, an _______, the sponsor, a monitor, or ______, including required ________________.
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Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial DisclosuresPart: 11 Electronic Records/Electronic Signatures
Regulatory OverviewCode of Federal Regulations
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Title: CRF Title 21
Chapter: Food and Drugs
Part: 312 Drugs
Part: 812 Devices
Part: 50 Protection of Human Subjects
Part: 56 Institutional Review Boards (IRBs)
Part: 54 Financial DisclosuresPart: 11 Electronic Records/Electronic Signatures
Regulatory OverviewCode of Federal Regulations
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• ISO 14155 has been designed for medical devices
• ICH GCP has origins in the pharmaceutical industry
• ISO 14115 and ICH GCP complement one another as they are based on the same principles:– Patient protection– Documentations– Risk-benefit assessments– Ensuring data validity
Regulatory OverviewGlobal Perspective
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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• Regulations that drugs and devices have in common:– 21 CFR 11 (electronic records)– 21 CFR 50 (protection of human subjects)– 21 CFR 54 (financial disclosure)– 21 CFR 56 (institutional review board)
Clinical Trial SimilaritiesRegulations
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• Within 21 CFR 312 and 21 CFR 812 are many similarities:– Submit to FDA before beginning an investigation– Update annually– Amendments required when changes are made– Promotion and charging for the product– Labeling– Waivers– Product accountability
Clinical Trial SimilaritiesRegulations
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Clinical Trial SimilaritiesSponsor Responsibilities
DRUGS DEVICES
•Select qualified investigators•Provide info to investigators•Ensure proper monitoring•Ensure trial is conducted in accordance with the general investigational plan and protocols
•Maintain an effective IND with respect to the investigations
•Ensure the FDA and investigators are promptly informed of significant new adverse effects or risks with respect to the drug
•Selecting qualified investigators•Provide info to investigators•Ensure proper monitoring •Ensure trial is conducted in accordance with the general investigational plan, protocol, agreement, IRB
•Ensure IRB review and approval•Ensure IRB and FDA are promptly informed of significant new information
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DRUGS DEVICES
312.56: ….(paraphrased) Ensuring that the investigation(s) is conducted in compliance with the investigational plan, the signed agreement, and the applicable regulations….
812.46: (paraphrased) Ensuring compliance with signed agreement, investigational plan, applicable FDA regulations, and IRB requirements....
Clinical Trial SimilaritiesSponsor Responsibilities
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DRUGS DEVICES
312.60: ….Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations....
812.110: An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
Clinical Trial SimilaritiesInvestigator Responsibilities
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Lots of Similarities!
Investigator responsibilitie
s similar
Sponsor responsibiliti
es similar
Trials organized differently
(defined phases v. pilot/pivotal), but many of the
same requirements
apply
Clinical Trial Similarities
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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Agreements
Training
Payments
Adverse Events
Clinical Trial DifferencesDifferences are in the Details
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In both drug studies and device studies, the FDA requires that the investigator comply with the agreements (21 CFR 312.56 and 21 CFR 812.46), however the agreements are not identical.
Clinical Trial DifferencesAgreements
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• The FDA Form 1572 is the agreement mandated by the FDA to be completed by all investigators involved in a drug trial.
• The agreement describes an investigator’s qualifications and specifies his or her commitment to adhering to applicable FDA regulations.
Clinical Trial DifferencesAgreements - Drugs
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Read the SMALL PRINT of the 1572, The Essential GCP Document; http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read the SMALL PRINT of the 1572
Read the SMALL PRINT of the 1572
SuperviseMaintain RecordsAdhere to protocolLearn investigator
brochureLet FDA inspect
rePort adverse eventsRetain recordsInform subjectsNotify IRBTrain staff
Clinical Trial DifferencesAgreements - Drugs
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Read the SMALL PRINT of the 1572, The Essential GCP Document; http://www.wlap.org/filearchive/cacr/CACR_CRE_ 2.ppt#256,1,Read the SMALL PRINT of the 1572
Read the SMALL PRINT of the 1572
SuperviseMaintain RecordsAdhere to protocolLearn investigator
brochureLet FDA inspect
rePort adverse eventsRetain recordsInform subjectsNotify IRBTrain staff
Clinical Trial DifferencesAgreements - Drugs
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• No standard format or specific form required• Direction provided as to what should be included in
the agreements (21 CFR 812.43)– Investigator qualifications– Commitment to conduct the study in accordance with
regulations– Commitment to supervise device use– Statement regarding involvement in research that was
terminated (if applicable)
Clinical Trial DifferencesAgreements - Devices
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Training should be approached differently when beginning a drug study versus beginning a device study.
Clinical Trial DifferencesTraining
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Drugs• Training on dispensing of product not likely to be needed• Burden of responsibility to comply with drug regimen lies with
patient/patient’s caregiver • A sponsor shall select only investigators qualified by training and
experience as appropriate experts to investigate the drug. 21 CFR 312.53
Devices• Training could be significant and might require the assistance of
engineers, product development, nurses, other physicians, etc.• Influence of physician technique can be very high depending on
the complexity of device study• A sponsor shall select investigators qualified by training and
experience to investigate the device. 21 CFR 812.43
Clinical Trial DifferencesTraining
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Product reimbursement varies quite a bit from drugs to devices.
Clinical Trial DifferencesPayments
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• Drugs are often provided free of charge to clinical sites and patients in clinical trials
• Devices expensive to produce
• Having to provide it free could cause a significant barrier to development
• For some studies, investigator could be charged for the device (then reimbursed by Medicare or private insurance) – “Category B Investigational Devices”
Clinical Trial DifferencesPayments
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Due to the systemic nature of drugs, all adverse events will need to be captured and analyzed as potentially related to the drug. Devices have a local affect, and the likelihood of an adverse event being related to the device is easier to determine. For this reason, not all negative occurrences in a device study are reportable.
Clinical Trial DifferencesAdverse Events
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AEs
ADEsUADEs
FDA UADEs
SADEs
Source: Michaels, MB, Applied Clinical Trials, August 2011, pages 36.
• AE: Adverse Effect
• SAE: Serious Adverse Effect
• ADE: Adverse Device Effect
• SADE: Serious Adverse Device Effect
• UADE: Unanticipated Adverse Device Effect
• FDA UADE: Unanticipated Adverse Device Effect that is also SERIOUS
Clinical Trial DifferencesAdverse events
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• UADEs- report to Sponsor and IRB no later than 10 days after learning of the event
Clinical Trial DifferencesAdverse Events
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• Immediately conduct investigation• If UADE presents unreasonable risks to
subjects, sponsor shall terminate all investigations within 5 working days of making that decision
Clinical Trial DifferencesAdverse Events
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Key Points
• Devices have local affect, drugs systemic
• Follow different regulatory pathways• Clinical trials very similar in
requirements• Differences lie in the details:
Agreements
Training
Payments
Adverse Events
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AgendaAn Overview of Drugs and Devices
Determining the Need for a Clinical Trial
Regulatory Overview
Clinical Trial Similarities
Clinical Trial Differences
FAIR Shake™- The Regulations
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Let’s Shake Things Up
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“You can fool all of the people some of the time, and some of the people all of the time, but you cannot fool all of the people all of the time.”
- Abraham Lincoln
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You Need To Bring It!
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21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 21CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; SPONSOR AND SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;IRB SOPs; It’s Complicated!
Sponsor
Sponsor Requirement
sGood
Clinical Practice
FDA Regulations
ICH Guidelines
Protocol RequirementsInvestigator
Agreements
ISO14155
NIH Guidelines
IRB Requirements
Internal Policies
What You Need to Know
CRO/Monitor
Research Site
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Adding To The Mix…
A decision about regulatory compliance made at one site for one study may not be the right decision at another site for the
same study or at the same site for another study….
Variable
Fixedversus
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21 CFR 812 - IDEs
• 812.110: An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
Investigator
• 812.46: (paraphrased) Ensuring compliance with signed agreement, investigational plan, applicable FDA regulations, and IRB requirements....
Sponsor
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Working through the chaos
Federal RegulationsAgreementsInvestigational PlanRequirements of IRB
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• Requirements for conducting clinical studies
• Outlines responsibilities of the sponsors, investigators, and IRBs for conducting trials involving human subjects
Federal Regulations
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IDEs (Investigational Device Exemptions)
Protection of Human Subjects
IRBs (Institutional Review Boards)
Financial Disclosures
Electronic Records/Signatures11
50
56
54
812
FDA Regulations to Know
Federal Regulations
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• Describes the procedures for the conduct of clinical investigations of devices
• Sponsor responsibilities
• Investigator responsibilities
Federal Regulations21 CFR 812 - IDEs
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Federal Regulations21 CFR 812 - IDEs
• 812.110: An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
Investigator
• 812.46: (paraphrased) Ensuring compliance with signed agreement, investigational plan, applicable FDA regulations, and IRB requirements....
Sponsor
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Federal Regulations21 CFR 812 - IDEs
• Overall conduct of a study:– Labeling – Promotion– Selection of Investigators– Monitoring (securing compliance)– Record keeping – IRB approval…..
DOCUMENT IT!
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• The rights, safety, and well-being of the trial subjects should prevail over interests of science and society.
• Freely given Informed Consent should be obtained from every subject prior to clinical trial participation.
• The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality
Federal Regulations21 CFR 50 – Human Subject Protection
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• Specifies:– Consenting procedures– Elements to include in an informed consent– Documentation of informed consent– Exceptions of informed consent– Safeguards for children/wards
Federal Regulations21 CFR 50 – Human Subject Protection
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• Sponsor obligations:– Ensure informed consent process at site level is
compliant with regulatory requirements
DOCUMENT IT!
Federal Regulations21 CFR 50 – Human Subject Protection
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• IRBs – Institutional Review Boards (Ethics Committees) Review and approve research studies involving human subjects
• 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA
•
Federal Regulations21 CFR 56 - IRBs
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An IRB has the authority to: • Approve research• Require modifications in research• Disapprove research• Require additional elements of informed consent
are provided• Waive the requirement for a signed informed
consent
Federal Regulations21 CFR 56 - IRBs
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• Sponsor’s obligations:– Ensure IRB is operating in compliance with 21 CFR 56– Ensure site is following IRB procedures
DOCUMENT IT!
Federal Regulations21 CFR 56 - IRBs
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• Protect the integrity and reliability of clinical data
• FDA considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias
• The FDA works with the applicant/sponsor to minimize potential bias
Federal Regulations21 CFR 54 – Financial Disclosure
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If financial interests raise questions about data integrity the FDA may:
• Initiate audits of the data from that investigator
• Request further analyses of data
• Request applicant to conduct additional studies
• Refuse the data
Investigator to Sponsor Sponsor to FDA
Federal Regulations21 CFR 54 – Financial Disclosure
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• Sponsor’s obligations:• Collect accurate investigator financial information before study
participation (21 CFR 812.43)• Report COI to FDA at time of application• Obtain updates throughout the study and for one year after all
study data is submitted
DOCUMENT IT!
Federal Regulations21 CFR 54 – Financial Disclosure
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• Describes How:– Electronic records, electronic signatures,
and handwritten signatures executed to electronic records are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Federal Regulations21 CFR 11 – Electronic Records
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• To ensure the authenticity, integrity and confidentiality of electronic records, controls include:
– Tracking of data entry with an audit trail (paper or electronic)
– Documented verification of data entry accuracy
– Unique electronic signatures
Federal Regulations21 CFR 11 – Electronic Records
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• Sponsor’s obligation:– Know the requirements of 21 CFR 11– Ensure site and internal (sponsor) compliance
DOCUMENT IT!
Federal Regulations21 CFR 11 – Electronic Records
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Working through the chaos
Federal RegulationsAgreementsInvestigational PlanRequirements of IRB
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• Statement of investigator’s commitment to:– Conduct the investigation in compliance with FAIR– Supervise device use– Obtain informed consent– Other items as agreed upon with sponsor…
Agreements
DOCUMENT IT!
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Federal RegulationsAgreementsInvestigational PlanRequirements of IRB
Working through the chaos
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• Inclusion / Exclusion
• Required Testing
• Procedural Requirements
• Randomization Processes
• Follow-up Requirements
Investigational Plan
DOCUMENT IT!
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Federal RegulationsAgreementsInvestigational PlanRequirements of IRB
Working through the chaos
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Requirements of IRB
• Informed consent procedures
• Adverse event reporting requirements
• Renewal timelines
• Etc.
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Case Study #1
You are monitoring a site when you notice that an investigator routinely signs the consent forms days after the patients sign them. You’re not sure what to do. The manager of the brand new research coordinator tells you that this is no big deal and there is nothing to address.
She said “It’s not in the regs…..” Is she right?
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Federal RegulationsAgreementsInvestigational PlanRequirements of IRB Could be specified by the IRB
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Case Study #2A monitor notes that all of the IRB approvals were on file at a site, but some of the correspondence back and forth regarding the approvals was missing. The RC refused to locate the missing documentation.
The monitor insists “It’s in the Regs….” Is the monitor correct?
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Federal Regulations
AgreementsInvestigational PlanRequirements of IRB
FDA requires that all correspondence with an IRB be maintained (21 CFR 812.140)
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Case Study #3You have a site that routinely takes case report forms (CRFs) into the exam room while seeing patients. While much of the information you need for the study is included in the patient’s regular assessment, they write the other data directly onto the CRF. You think they need a separate source, but you’re not sure.
You dig into the regulations and find what???
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Federal RegulationsAgreementsInvestigational PlanRequirements of IRB
Could be in an agreement
Could be in an investigational plan
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Sandra MaddockCEO and President
John LehmanDirector of Business Development
Meet Our Team
Brandy SmithDirector of Clinical Monitoring Services
Mary LewisClinical Auditor
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More Information for You
Download our Whitepapers
Drugs vs. Devices
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• FDA’s official website:• www.fda.gov
• GCP Guidances and Information Sheets• http://www.fda.gov/oc/gcp/guidance.html
• Informed Consent• A Guide To Informed Consent:
• http://www.fda.gov/oc/ohrt/irbs/informedconsent.html• Protection of Subjects:
• http://www.fda.gov/cdrh/devadvice/ide/informed_consent.shtml• Running clinical trials
• http://1.usa.gov/ILt1tc
References