CPI Investigator Responsibilities & Reporting 2 — Questions and Answers
Question 1: An investigator discovers a protocol deviation that did not harm the subject but was not pre-approved. What is the FIRST action to take?
- Correct the deviation silently and continue the study
- Report the deviation to the IRB and sponsor per protocol requirements (Correct answer)
- Withdraw the affected subject from the study immediately
- Amend the informed consent form before notifying anyone
Correct 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.
Question 2: Under 21 CFR Part 312, what is the investigator's obligation when they permanently discontinue or temporarily suspend a clinical investigation?
- Notify the FDA within 30 days via Form FDA 1572
- Immediately notify the IRB and the sponsor of the discontinuation (Correct answer)
- Complete all subject follow-up visits before notifying any party
- Destroy all investigational product and study records
Correct 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.
Question 3: Which of the following best describes the investigator's responsibility regarding the delegation log?
- It is optional documentation maintained only at multi-site trials
- It must list all sub-investigators and study staff with their delegated tasks and qualifications (Correct answer)
- It only needs to include licensed physicians assisting with the study
- It is maintained by the sponsor and not the investigator's responsibility
Correct 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.
Question 4: A subject enrolled in a trial is found to have falsified their eligibility criteria at screening. What should the investigator do?
- Allow the subject to continue since they are already enrolled
- Document the finding, notify the IRB and sponsor, and determine appropriate action per protocol (Correct answer)
- Immediately remove the subject and destroy their records
- Report only to the sponsor and continue the visit
Correct 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.
Question 5: In the context of CPI responsibilities, what does the term 'sponsor-investigator' mean?
- An investigator who receives financial compensation from the sponsor
- An individual who both initiates and conducts a clinical investigation (Correct answer)
- A sponsor employee who oversees multiple site investigators
- An IRB-designated investigator who approves protocol amendments
Correct 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.
Question 6: Which document must a CPI investigator sign to commit to conducting the study per GCP and applicable regulations?
- Clinical Study Report
- Form FDA 1572 (Statement of Investigator) (Correct answer)
- Investigator Brochure acknowledgment
- IRB approval letter
Correct 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.
Question 7: An investigator receives new safety information from the sponsor about an increased risk associated with the investigational product. What is the MOST immediate obligation?
- Suspend enrollment until the IRB reviews the information
- Assess the impact on enrolled subjects and notify the IRB in a timely manner (Correct answer)
- Disregard unless FDA issues a formal safety alert
- Wait for a protocol amendment before taking any action
Correct 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.
CPI Investigator Responsibilities & Reporting 2
An investigator discovers a protocol deviation that did not harm the subject but was not pre-approved.
What is the FIRST action to take?