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
An investigator discovers a protocol deviation that did not harm the subject but was not pre-approved. What is the FIRST action to take?
Answer: Report the deviation to the IRB and sponsor per protocol requirements
Protocol deviations must be reported to the IRB and sponsor promptly, even if no harm occurred, to maintain study integrity.
Under 21 CFR Part 312, what is the investigator's obligation when they permanently discontinue or temporarily suspend a clinical investigation?
Answer: Immediately notify the IRB and the sponsor of the discontinuation
The investigator must promptly notify both the IRB and sponsor when discontinuing or suspending an investigation.
Which of the following best describes the investigator's responsibility regarding the delegation log?
Answer: It must list all sub-investigators and study staff with their delegated tasks and qualifications
The delegation log documents all personnel to whom the investigator has delegated study tasks, along with their specific responsibilities and qualifications.
A subject enrolled in a trial is found to have falsified their eligibility criteria at screening. What should the investigator do?
Answer: Document the finding, notify the IRB and sponsor, and determine appropriate action per protocol
Protocol eligibility violations require notification to the IRB and sponsor, with subject management decisions guided by the protocol and oversight bodies.
In the context of CPI responsibilities, what does the term 'sponsor-investigator' mean?
Answer: An individual who both initiates and conducts a clinical investigation
A sponsor-investigator is an individual who both initiates and conducts a clinical investigation and assumes all sponsor and investigator responsibilities.
Which document must a CPI investigator sign to commit to conducting the study per GCP and applicable regulations?
Answer: Form FDA 1572 (Statement of Investigator)
FDA Form 1572 is the Statement of Investigator that formally commits the investigator to conducting the study in compliance with FDA regulations and the protocol.
An investigator receives new safety information from the sponsor about an increased risk associated with the investigational product. What is the MOST immediate obligation?
Answer: Assess the impact on enrolled subjects and notify the IRB in a timely manner
Investigators must promptly assess new safety information and report it to the IRB, as it may require consent form updates or protocol changes to protect subjects.