CPI CPI Clinical Site Operations & Investigational Product 2 — Questions and Answers
Question 1: What is an FDA Form 1572 (Statement of Investigator), and when must it be completed?
- A form binding the PI to comply with FDA regulations, completed before initiating an IND study (Correct answer)
- A form submitted after each patient visit to the FDA
- An annual financial disclosure form for clinical investigators
- A form used to report serious adverse events to the FDA
Correct answer: A form binding the PI to comply with FDA regulations, completed before initiating an IND study
FDA Form 1572 is a legal agreement committing the PI to conduct the study per FDA regulations and is required before initiating any IND-regulated clinical study.
Question 2: A sponsor's monitor requests access to participant medical records to verify source data. What must the PI ensure is in place before allowing this access?
- A signed authorization or HIPAA waiver permitting data access for monitoring purposes (Correct answer)
- Verbal agreement from the participant at enrollment
- IRB standing approval for all future monitor visits
- Sponsor indemnification agreement
Correct answer: A signed authorization or HIPAA waiver permitting data access for monitoring purposes
Participants must authorize disclosure of their records for monitoring, auditing, and regulatory inspection purposes, typically captured in the informed consent form.
Question 3: What is the PI's responsibility when an FDA inspector arrives unannounced for a For-Cause inspection?
- Cooperate fully, provide requested records promptly, and notify the sponsor immediately (Correct answer)
- Refuse access until legal counsel is present
- Contact the IRB to reschedule the inspection
- Forward the inspector to the institution's compliance office only
Correct answer: Cooperate fully, provide requested records promptly, and notify the sponsor immediately
PIs must cooperate with FDA inspections, provide requested records, and promptly notify the sponsor of the inspection.
Question 4: What is a 'Protocol Deviation' as defined in clinical research?
- Any unplanned departure from the IRB-approved protocol (Correct answer)
- A planned change to the protocol submitted as an amendment
- A missed participant visit that is rescheduled within the window
- A sponsor-approved modification to the CRF
Correct answer: Any unplanned departure from the IRB-approved protocol
A protocol deviation is any unplanned or unintentional departure from the approved protocol that occurs during the conduct of the study.
Question 5: Which of the following is classified as a 'Major' (or significant) protocol deviation requiring immediate IRB reporting?
- Enrollment of a participant who did not meet an eligibility criterion (Correct answer)
- A participant who missed one optional questionnaire
- A blood draw performed 2 hours outside the protocol window
- A staff member completing a training module one week late
Correct answer: Enrollment of a participant who did not meet an eligibility criterion
Enrolling an ineligible participant is a major deviation because it may compromise participant safety, data integrity, and study validity, requiring prompt IRB and sponsor reporting.
Question 6: Essential documents for a clinical trial site must be retained for at least how long after the completion or discontinuation of the study, per ICH GCP E6(R2)?
- At least 2 years after the last approval of a marketing application or after discontinuation of development (Correct answer)
- Six months after the final site monitoring visit
- One year after the last participant's last visit
- Until the sponsor requests destruction
Correct answer: At least 2 years after the last approval of a marketing application or after discontinuation of development
ICH GCP E6(R2) requires essential documents be retained for at least 2 years after the last approval of a marketing application or after formal discontinuation of development.
CPI CPI Clinical Site Operations & Investigational Product 2
What is an FDA Form 1572 (Statement of Investigator), and when must it be completed?