CPI Investigator Responsibilities & Reporting 3 — Questions and Answers
Question 1: How long must clinical investigators retain study records after the completion or discontinuation of the clinical investigation under FDA regulations?
- 1 year after study completion
- 2 years after the date a marketing application is approved or discontinued (Correct answer)
- 5 years after study completion regardless of marketing status
- Until the IRB formally closes the study file
Correct answer: 2 years after the date a marketing application is approved or discontinued
Under 21 CFR 312.62, investigators must retain records for 2 years after the date a marketing application is approved or after investigation is discontinued.
Question 2: A sub-investigator at a clinical trial site wants to enroll a relative as a research subject. What is the BEST course of action?
- Allow enrollment since the sub-investigator can objectively evaluate the relative
- Decline enrollment or ensure an independent evaluator obtains consent to avoid undue influence (Correct answer)
- Have the relative sign a waiver of conflict and proceed normally
- Allow enrollment only if the relative provides written permission to the IRB
Correct answer: Decline enrollment or ensure an independent evaluator obtains consent to avoid undue influence
Enrolling relatives creates a coercive situation; an independent party should obtain consent or the subject should not be enrolled to protect voluntary participation.
Question 3: What is the investigator's responsibility when the IRB requests modifications to the study protocol before granting approval?
- Begin the study under the original protocol and address modifications later
- Implement the requested modifications and resubmit for IRB review before starting the study (Correct answer)
- Submit the modification requests to the FDA for final determination
- Proceed with enrollment while modifications are under review
Correct answer: Implement the requested modifications and resubmit for IRB review before starting the study
Investigators must not begin a study until the IRB has reviewed and approved the protocol, including any modifications the IRB requires.
Question 4: An investigator conducting a multi-site trial identifies that another site is not following GCP. What is their responsibility?
- Report the non-compliance directly to the FDA on behalf of the other site
- Report concerns to the sponsor so the sponsor can address the issue with the non-compliant site (Correct answer)
- No responsibility exists, as each investigator is only accountable for their own site
- Request the IRB to revoke approval from the non-compliant site
Correct answer: Report concerns to the sponsor so the sponsor can address the issue with the non-compliant site
An investigator's primary responsibility is to their own site; concerns about other sites should be escalated to the sponsor, who bears oversight responsibility across all sites.
Question 5: Which of the following constitutes a 'serious breach' of GCP that an investigator must report to the sponsor immediately?
- A minor administrative error in source documentation
- Enrollment of a subject who did not meet inclusion/exclusion criteria without prior authorization (Correct answer)
- A 2-hour delay in study drug administration not clinically significant
- A minor deviation from the visit window by one day
Correct answer: Enrollment of a subject who did not meet inclusion/exclusion criteria without prior authorization
Enrolling subjects who do not meet eligibility criteria is a serious breach that jeopardizes subject safety and data integrity, requiring immediate reporting.
Question 6: What is an investigator's responsibility regarding investigational product (IP) accountability?
- Accountability is solely the pharmacy's responsibility at institutional sites
- Maintain accurate records of IP receipt, use, and disposition, and allow sponsor access to these records (Correct answer)
- Document only IP that is dispensed to subjects; unused product need not be tracked
- Return all unused IP to the sponsor without maintaining records
Correct answer: Maintain accurate records of IP receipt, use, and disposition, and allow sponsor access to these records
Investigators must maintain complete IP accountability records including receipt, dispensing, and returns, and allow sponsor and regulatory access for audit.
Question 7: A clinical investigator is asked by a colleague outside the study to share identifiable subject data to assist with another research project. What should the investigator do?
- Share the data if the colleague is also a licensed physician
- Decline unless the subject has consented to the additional use and applicable regulatory requirements are met (Correct answer)
- Share de-identified data freely as HIPAA only restricts identifiable information
- Obtain verbal consent from the subject by phone before sharing
Correct answer: Decline unless the subject has consented to the additional use and applicable regulatory requirements are met
Sharing identifiable subject data requires explicit subject consent and compliance with HIPAA and applicable regulations; verbal permission alone is insufficient.
CPI Investigator Responsibilities & Reporting 3
How long must clinical investigators retain study records after the completion or discontinuation of the clinical investigation under FDA regulations?