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“So You Think You Know GCP ...”
Northern California Chapter ACRP
March 21, 2013
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Presenter
Paul Below, MS, CCRA• Clinical Project Leader, American Medical Systems
• Trainer for ACRP
• Former President Minnesota Chapter ACRP (2004, 2010)
• Adjunct instructor for the St. Cloud State University Master’s Degree Program in Applied Clinical Research
• Recipient of ACRP’s Leadership in Clinical Research as a CRA Award in May 2011
• Recipient of ACRP’s Top Speaker Award for the 2012 Global Conference
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Disclosure
• Paul has no relevant financial relationship in relation to this educational activity
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Background
• This presentation was developed to correct numerous errors and myths about Good Clinical Practice overheard by the presenter throughout his clinicalresearch career
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Are you sure this is right? I’ve
never been asked to document it
this way before.
Yes, you have to do it this way. It’s an FDA requirement.
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I never heard of this FDA requirement before but it
must be true. He is the monitor and he should
know …
I wouldn’t count on it
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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
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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
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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
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Sample TitleSample Text
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GCP
Other Federal Regulations
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
IndustryBest Practices
• 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)
FDA Regulations(21 CFR)
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Sample TitleSample Text
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GCPState Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
IndustryBest Practices
FDA Regulations(21 CFR)
• 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
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Sample TitleSample Text
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GCP
Other Federal Regulations
State Law
Local Law (Institutional
and IRB Policies)
InternationalStandards
Sponsor SOPs
IndustryBest Practices
FDA Regulations(21 CFR)
• 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 GuidanceDocuments
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Sample TitleSample Text
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GCP
Other Federal Regulations
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
Sponsor SOPs
IndustryBest Practices
FDA Regulations(21 CFR)
• 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
InternationalStandards
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Sample TitleSample Text
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GCP
Other Federal Regulations
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
IndustryBest Practices
FDA Regulations(21 CFR) • Age of consent
• Legally authorized representatives
• Clinical research registration
• Medical records privacy
• Gene research
• STD/HIV reporting
• Gifts to practitioners
State Laws
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GCP
Other Federal Regulations
State Law
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
IndustryBest Practices
FDA Regulations(21 CFR)
• 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
Local Law (Institutional
and IRB Policies)
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Sample TitleSample Text
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GCP
Other Federal Regulations
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
IndustryBest Practices
FDA Regulations(21 CFR)
• 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
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Sample Text
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GCP
Other Federal Regulations
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
FDA Regulations(21 CFR)
• 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
IndustryBest Practices
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Sample TitleSample Text
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GCP
Other Federal Regulations
FDA Regulations(21 CFR)
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
InternationalStandards
Sponsor SOPs
IndustryBest Practices
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Learning all of the parts of GCP can take some time and may seem daunting to those new to the
clinical research industry
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Time to Test Your GCP Knowledge
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• 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)
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How to Vote by Text Message
Example Question: What is your favorite color?
• Red 3544
• Blue 3545
• Green 3546
• Orange 3546
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
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Informed Consent
Questions
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FDA Regulations (21 CFR 50) specify the following:Question Keyword
The ICF must be signed and dated by the subject 624626
The ICF must be signed and dated by the person obtaining consent
624627
The ICF must be signed and dated by the Principal Investigator 624628
The ICF must be signed by a child subject if the IRB determines that assent is required
624651
All of the above 624655
Question
24
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FDA Regulations (21 CFR 50) specify the following:Question Keyword
The ICF must be signed and dated by the subject 624626
The ICF must be signed and dated by the person obtaining consent
624627
The ICF must be signed and dated by the Principal Investigator 624628
The ICF must be signed by a child subject if the IRB determines that assent is required
624651
All of the above 624655
Text your answer (keyword) to 22333
Question
25
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2626
FDA Regulations (21 CFR 50) specify the following:Question Keyword
The ICF must be signed and dated by the subject 624626
The ICF must be signed and dated by the person obtaining consent
624627
The ICF must be signed and dated by the Principal Investigator 624628
The ICF must be signed by a child subject if the IRB determines that assent is required
624651
All of the above 624655
Specified in 21 CFR 50.27a
Answer
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• 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
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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 624669
When it is anticipated that consent interviews will be conducted in a foreign language, a translated ICF should be prepared
624727
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
624773
All study personnel involved in the informed consent process should be trained in Human Subjects Protection
624774
All of the above 624775
Question
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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 624669
When it is anticipated that consent interviews will be conducted in a foreign language, a translated ICF should be prepared
624727
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
624773
All study personnel involved in the informed consent process should be trained in Human Subjects Protection
624774
All of the above 624775
Answer
29
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.
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• 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
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• 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
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Financial DisclosureQuestion
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3333
FDA Regulations (21 CFR 54) specify the following:Question Keyword
Part- or full-time employees of the sponsor may not participate as Clinical Investigators in that sponsor’s trials
624803
Clinical Investigators may not have a proprietary interest (i.e., patents, royalties) in the tested product in a trial
624804
Clinical Investigators may not receive more than $25,000 a year in “payments of other sorts” (i.e., grants, consulting fees, speaker honoraria)
624812
In general, financial disclosure is not required for large open safety studies conducted at multiple sites
624813
None of the above 625046
Question
33
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FDA Regulations (21 CFR 54) specify the following:Question Keyword
Part- or full-time employees of the sponsor may not participate as Clinical Investigators in that sponsor’s trials
624803
Clinical Investigators may not have a proprietary interest (i.e., patents, royalties) in the tested product in a trial
624804
Clinical Investigators may not receive more than $25,000 a year in “payments of other sorts” (i.e., grants, consulting fees, speaker honoraria)
624812
In general, financial disclosure is not required for large open safety studies conducted at multiple sites
624813
None of the above 625046
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.
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• 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
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• 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
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IRBQuestion
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3838
FDA Regulations (21 CFR 56) specify the following:Question Keyword
An IRB must be composed of five (5) members 625047
An IRB must have at least one female member 625048
If an IRB regularly reviews research involving prisoners, a prisoner representative should be included on the board
625049
An IRB member that has a conflicting interest in a project under review may not participate in the IRB's review proceedings
625076
None of the above 625077
Question
38
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3939
FDA Regulations (21 CFR 56) specify the following:Question Keyword
An IRB must be composed of five (5) members 625047
An IRB must have at least one female member 625048
If an IRB regularly reviews research involving prisoners, a prisoner representative should be included on the board
625049
An IRB member that has a conflicting interest in a project under review may not participate in the IRB's review proceedings
625076
None of the above 625077
Answer
39
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• 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
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Explanation
41
• 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).
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MonitoringQuestion
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4343
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
627475
Monitors should not make any notations or corrections on the CRF pages
627539
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
627540
Monitors should attempt to meet in person with the Investigator at every visit to discuss the progress of the trial
627541
All of the above 627542
Question
43
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4444
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
627475
Monitors should not make any notations or corrections on the CRF pages
627539
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
627540
Monitors should attempt to meet in person with the Investigator at every visit to discuss the progress of the trial
627541
All of the above 627542
Answer
Specified in ICH 5.18.6a
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• 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
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• 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
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SourceDocumentation
Question
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4848
FDA Regulations (21 CFR 312/812) specify the following:Question Keyword
It is prohibited to use CRFs (other than questionnaires) directly as source documents
625078
Each subject’s case history should document that informed consent was obtained prior to participation in the study
625079
All source documents must be signed by the completer 625089
If a site uses electronic medical records as source documents, the EMR system must be compliant with 21 CFR part 11
625090
All of the above 625091
Question
48
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4949
FDA Regulations (21 CFR 312/812) specify the following:Question Keyword
It is prohibited to use CRFs (other than questionnaires) directly as source documents
625078
Each subject’s case history should document that informed consent was obtained prior to participation in the study
625079
All source documents must be signed by the completer 625089
If a site uses electronic medical records as source documents, the EMR system must be compliant with 21 CFR part 11
625090
All of the above 625091
Answer
49
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)
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• 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
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• 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
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InvestigatorResponsibilities
Question
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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
625092
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)
625093
Investigators should develop a plan for the oversight of the clinical trial that might include the creation of specific SOPs
625096
Investigators conducting studies of drugs with potentially fatal toxicity should be readily available 24 hours/day and in reasonably close proximity to study subjects
625097
All of the above 625098
Question
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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
625092
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)
625093
Investigators should develop a plan for the oversight of the clinical trial that might include the creation of specific SOPs
625096
Investigators conducting studies of drugs with potentially fatal toxicity should be readily available 24 hours/day and in reasonably close proximity to study subjects
625097
All of the above 625098
Answer
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Study Records Storage
Question
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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
625099
In general, study records should be obtained indefinitely because it is never certain when product development will be permanently discontinued by the sponsor
625114
Sponsors should pay for the costs of records storage by Investigators
625115
For device studies, an Investigator may transfer custody of study records to anyone who will accept responsibility for them
625116
None of the above 625117
Question
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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
625099
In general, study records should be obtained indefinitely because it is never certain when product development will be permanently discontinued by the sponsor
625114
Sponsors should pay for the costs of records storage by Investigators
625115
For device studies, an Investigator may transfer custody of study records to anyone who will accept responsibility for them
625116
None of the above 625117
Answer
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Specified in 21 CFR 812.140e (however, there is no comparable language in Part 312)
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• 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
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• 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
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• 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
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In Conclusion
That doesn’t sound right to me. Where
exactly is that listed in the CFR?
Yes, you have to do it this way. It’s an FDA requirement.
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In Conclusion
Well, uh …OK, maybe it’s not a
regulation but it’s what the FDA
expects.
That still doesn’t sound right. What
guidance document is that from?
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In Conclusion
I’m not sure but it doesn’t matter. It’s a
requirement of my sponsor company.
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In Conclusion
OK, that’s fine. Why didn’t you just say so in the first place? I’m happy to do it to satisfy
your company policy. You didn’t have to use those FDA excuses to justify your request.
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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
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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
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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”
Compliance Toolbox
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Thank You
• Thanks for the Northern California Chapter for the invitation to present
• Thanks also to the chapter leadership for all that they do for ACRP and the local research community
• Consider volunteering with the outstanding group – it is well worth the time!
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• Paul Below, [email protected]
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You are welcome to use these slides for your own internal training purposes but they remain the copyrighted property of the presenter. Please contact Paul for permission to reuse.