Investigator Responsibilities & Reporting Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigator Responsibilities & Reporting flashcards as text
How long must clinical investigators retain study records after the completion or discontinuation of the clinical investigation under FDA regulations?
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.
A sub-investigator at a clinical trial site wants to enroll a relative as a research subject. What is the BEST course of action?
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.
What is the investigator's responsibility when the IRB requests modifications to the study protocol before granting approval?
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.
An investigator conducting a multi-site trial identifies that another site is not following GCP. What is their responsibility?
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.
Which of the following constitutes a 'serious breach' of GCP that an investigator must report to the sponsor immediately?
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.
What is an investigator's responsibility regarding investigational product (IP) accountability?
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.
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?
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.