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““So You Think You So You Think You Know GCP …”Know GCP …”
Session S794
Jill Matzat, RN, BSN, CCRA, CCRTPresident, Medical Research Management
& CRA Solutions, Inc.
Paul Below, CCRA, CCRTClinical Research Consultant, P. Below Consulting, Inc.
DisclosureDisclosure• Jill Matzat and Paul Below
have no relevant financial relationships in relation to this educational activity
BackgroundBackground• This presentation was developed to counter
numerous misconceptions and myths about Good Clinical Practice overheard by the presenters during their careers
• This presentation is intended to teach GCP concepts using a quiz format (audience polling is available via text message voting)
Learning ObjectivesLearning Objectives• Define Good Clinical Practice (GCP)
• Differentiate between FDA requirements (stated in regulation) and FDA recommendations (stated in guidance documents) in several key areas
• Identify several circumstances where “industry best standard” practices exist that go above and beyond what the FDA requires and even recommends
What is Good Clinical Practice?What is Good Clinical Practice?• 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
GCP
Other Federal Regulations
FDA Regulations(21 CFR)
State Law
Local Law (Institutional
and IRB Policies)
FDA GuidanceDocuments
ICH Guidelines for GCP
Sponsor SOPs
IndustryBest Practices
So You Think Know GCP …So You Think Know GCP …• The following slides are a series of questions to
test your knowledge of GCP
• You will be able to submit your answers via text messaging
• All answers areanonymous (no oneis identified by name or phone number)
How To Vote via TextingHow To Vote via TextingExample Question: What is your favorite color?
• Blue (72612)
• Red (72613)
• Green (72614)
• Yellow (72615)
To vote, text the corresponding keyword to 22333
NOTE: Standard text messaging rates apply.
Some Notes on TerminologySome Notes on Terminology• “The FDA requires” = it is specified in regulation
• “The FDA recommends” = it is specified in an FDA guidance document
Informed Consent QuestionInformed Consent Question
FDA regulations require the following:
Answer Keyword
The ICF must be signed by the subject 239432
The ICF must be signed by the person obtaining consent
239433
The ICF must be signed by the investigator 239434
Every page of the ICF must be initialed by the subject
239435
All of the above 239436
Text your answer (keyword) to 22333
FDA regulations require the following:
Answer Keyword
The ICF must be signed by the subject 239432
The ICF must be signed by the person obtaining consent
239433
The ICF must be signed by the investigator 239434
Every page of the ICF must be initialed by the subject
239435
All of the above 239436
Per 21 CFR 50.27, the informed consent form should be “signed and dated by the subject or the subject's legally authorized representative at the time of consent”
However, FDA guidance (ICH GCP) also recommends that the form be signed by the person obtaining the consent
Other ICF MisconceptionsOther ICF Misconceptions• It is acceptable for the study staff to date the
consent for the subject if they forgot to do so
• A spouse can always function as a “legally authorized representative”
• Consent forms must be written at a 6th grade reading level
Form FDA 1572 QuestionForm FDA 1572 Question
FDA guidance recommends the following:Answer Keyword
The signed 1572 must be submitted to the FDA prior to the Investigator’s participation in the trial
236113
The 1572 must be updated when new sub-investigators are added to Box #6
236114
The Principal Investigator must be a physician 236115
Only one Principal Investigator should be listed in Box #1
236116
All of the above 236117
Text your answer (keyword) to 22333
FDA guidance recommends the following:Answer Keyword
The signed 1572 must be submitted to the FDA prior to the Investigator’s participation in the trial
236113
The 1572 must be updated when new sub-investigators are added to Box #6
236114
The Principal Investigator must be a physician 236115
Only one Principal Investigator should be listed in Box #1
236116
All of the above 236117
A recent FDA Guidance Document was issued in May 2010 to clarify the agency’s expectations regarding completion the form.
Other 1572 MisconceptionsOther 1572 Misconceptions• Must be completed on a double-sided form
• Must be typed
• Study Coordinators should not be listed as Sub-Investigators in Box #6
• All rotating study staff (e.g., residents, fellows) must be listed as Sub-Investigators in Box #6
Curriculum Vitae (CV) QuestionCurriculum Vitae (CV) Question
FDA regulations require the following:
Answer Keyword
CVs must be collected for all investigators (PI and all Sub-investigators)
239968
CVs must be collected at the beginning of the study
239969
CVs must be “up-to-date” 239970
CVs must be signed and dated by the completer
239971
All of the above 239972
Text your answer (keyword) to 22333
FDA regulations require the following:
Answer Keyword
CVs must be collected for all investigators (PI and all Sub-investigators)
239968
CVs must be collected at the beginning of the study
239969
CVs must be “up-to-date” 239970
CVs must be signed and dated by the completer
239971
All of the above 239972
Per 21 CFR 312.23 (a)(6)(iii)(a), Sponsors need to include in their initial IND submission a statement of the qualifications (curriculum vitae or other statement of qualifications) of each Principal Investigator and only the names of each Sub-Investigator
FDA regulations require the following:
Answer Keyword
CVs must be collected for all investigators (PI and all Sub-investigators)
239968
CVs must be collected at the beginning of the study
239969
CVs must be “up-to-date” 239970
CVs must be signed and dated by the completer
239971
All of the above 239972
However, FDA guidance (ICH GCP) recommends that the Investigator CV be “up-to-date” (4.1.1) and be collected for all PIs and Sub-Investigators (8.2.10)
Case Report Form QuestionCase Report Form Question
FDA guidance recommends the following:Answer Keyword
CRF corrections should be dated and initialed and should not obscure the original entry
241939
When CRFs are used as source documents, they should be specified in the protocol
241940
Sponsors may make changes to the CRF data with the authorization of the investigator
241941
All of the above 241942
None of the above 241943
Text your answer (keyword) to 22333
FDA guidance recommends the following:Answer Keyword
CRF corrections should be dated and initialed and should not obscure the original entry
241939
When CRFs are used as source documents, they should be specified in the protocol
241940
Sponsors may make changes to the CRF data with the authorization of the investigator
241941
All of the above 241942
None of the above 241943All of the above are specified in ICH GCP
FDA guidance recommends the following:Answer Keyword
CRF corrections should be dated and initialed and should not obscure the original entry
241939
When CRFs are used as source documents, they should be specified in the protocol
241940
Sponsors may make changes to the CRF data with the authorization of the investigator
241941
All of the above 241942
None of the above 241943
There is nothing in FDA regulation or guidance that specifies that CRF corrections must be made with a single line through the original entry
Investigational Product Investigational Product QuestionQuestion
FDA regulations require the following:
Answer Keyword
Investigational product (IP) must be stored in a secure location with limited access
239961
IP must be environmentally monitored and controlled
239962
IP must be labeled with “Caution: New Drug (or Device) -- Limited by Federal (or United States) law to investigational use.”
239963
All unused IP must be returned to the sponsor at the end of the trial
239964
Text your answer (keyword) to 22333
FDA regulations require the following:
Answer Keyword
Investigational product (IP) must be stored in a secure location with limited access
239961
IP must be environmentally monitored and controlled
239962
IP must be labeled with “Caution: New Drug (or Device) -- Limited by Federal (or United States) law to investigational use.”
239963
All unused IP must be returned to the sponsor at the end of the trial
239964
Labeling requirements are specified for drugs in 21 CFR 312.6 and for devices in 21 CFR 812.5
FDA regulations require the following:
Answer Keyword
Investigational product (IP) must be stored in a secure location with limited access
239961
IP must be environmentally monitored and controlled
239962
IP must be labeled with “Caution: New Drug (or Device) -- Limited by Federal (or United States) law to investigational use.”
239963
All unused IP must be returned to the sponsor at the end of the trial
239964
The only language in the device or drug regulations related to IP storage concerns investigational drugs that are controlled substances (21 CFR 312.69, “storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited …”)
FDA regulations require the following:
Answer Keyword
Investigational product (IP) must be stored in a secure location with limited access
239961
IP must be environmentally monitored and controlled
239962
IP must be labeled with “Caution: New Drug (or Device) -- Limited by Federal (or United States) law to investigational use.”
239963
All unused IP must be returned to the sponsor at the end of the trial
239964
21 CFR 312.59 indicates sponsors “may authorize alternative disposition” for unused investigational drugs
21 CFR 812.110 indicates that investigators can “otherwise dispose of the device as the sponsor directs”
Emergency Use of IP Emergency Use of IP QuestionQuestion
If IP is used in a life-threatening situation prior to obtaining informed consent, what is the required time frame to report this to the IRB?
Answer Keyword
Promptly 241377
Within 24 hours 241378
Within 3 calendar days 241379
Within 3 working days 241380
Within 5 working days 241381
Text your answer (keyword) to 22333
If IP is used in a life-threatening situation prior to obtaining informed consent, what is the required time frame to report this to the IRB?
Answer Keyword
Promptly 241377
Within 24 hours 241378
Within 3 calendar days 241379
Within 3 working days 241380
Within 5 working days 241381
Reporting requirements for all products are specified in 21 CFR 50.23: “shall be submitted to the IRB within 5 working days after the use of the test article”
Regulatory Document Regulatory Document QuestionQuestion
FDA regulations require that the following documents be signed by the investigator:
Answer Keyword
Trial Delegation Log 241496
Completed and final case report forms 241497
Financial disclosure forms 241498
Protocol signature pages 241499
All of the above 241500
None of the above 241501
Text your answer (keyword) to 22333
FDA regulations require that the following documents be signed by the investigator:
Answer Keyword
Trial Delegation Log 241496
Completed and final case report forms 241497
Financial disclosure forms 241498
Protocol signature pages 241499
All of the above 241500
None of the above 241501
The only document specified by FDA regulation that must be signed by the investigator is the Form FDA 1572 (for drugs) or the Investigator Agreement (for devices)
Closing ThoughtsClosing Thoughts• Most FDA requirements are vague and open to
some interpretation
• Most of what we do in clinical research is driven by our own industry best practices and not FDA requirements or even recommendations
• 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
Poll ResultsPoll Results• Complete poll results are available at:
www.pbelow-consulting.com/ACRP2011.html
Your Chance to Ask Us QuestionsYour Chance to Ask Us Questions
Contact InformationContact Information• Jill Matzat
jmatzat@cra-training.comCome visit Jill at the Medical Research Management booth in the exhibit hall
• Paul Belowpaul@pbelow-consulting.com
Paul presents again on Monday at 4:15 pm (S831 - You've Discovered Fraud - Now What Do You Do?)
Poll results available at www.pbelow-consutling.com/ACRP2011.html
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