SOCRA Essential Study Documents 2 — Questions and Answers
Question 1: FDA Form 1572 (Statement of Investigator) must be signed by whom?
- The IRB chairperson
- The principal investigator only (Correct answer)
- Both the PI and all sub-investigators
- The sponsor's medical monitor
Correct answer: The principal investigator only
Only the principal investigator signs FDA Form 1572, taking personal responsibility for the conduct of the study.
Question 2: Under 21 CFR Part 312, how long must an investigator retain study records after the investigation is discontinued or completed?
- 2 years (Correct answer)
- 5 years
- 10 years
- 15 years
Correct answer: 2 years
Investigators must retain study records for at least 2 years after the last approval of a marketing application or after the investigation is discontinued.
Question 3: A sub-investigator joins the study after activation. What document must be updated immediately?
- The Investigator's Brochure
- The protocol
- The Delegation of Authority log (Correct answer)
- The IRB approval letter
Correct answer: The Delegation of Authority log
The Delegation of Authority (DOA) log must be updated to reflect any new personnel and the tasks they are delegated before they perform study activities.
Question 4: Which financial disclosure form is required from clinical investigators under 21 CFR Part 54?
- FDA Form 1571
- FDA Form 1572
- FDA Form 3454 or 3455 (Correct answer)
- FDA Form 483
Correct answer: FDA Form 3454 or 3455
FDA Form 3454 (certification of no financial interest) or Form 3455 (disclosure of financial interest) is required under 21 CFR Part 54.
Question 5: Which laboratory document must be on file at an investigative site to validate clinical laboratory test results?
- The lab director's CV
- Normal reference ranges and lab certification/accreditation documents (Correct answer)
- The sponsor's lab manual only
- A signed confidentiality agreement
Correct answer: Normal reference ranges and lab certification/accreditation documents
Normal reference ranges and laboratory certification or accreditation documents (e.g., CLIA) must be on file to validate the clinical significance of lab results.
Question 6: When an investigator fails to obtain IRB approval before enrolling subjects, this constitutes:
- A protocol deviation
- A protocol violation
- A serious breach (Correct answer)
- An adverse event
Correct answer: A serious breach
Enrolling subjects without prior IRB approval is a serious breach of GCP and regulatory requirements, reportable to the sponsor and potentially to regulatory authorities.
Question 7: What must be documented when an investigator delegates a study task to a site staff member?
- Only the staff member's name and date
- The specific tasks delegated, start/stop dates, and staff member's signature (Correct answer)
- A verbal agreement witnessed by a third party
- The sponsor's written approval of that staff member
Correct answer: The specific tasks delegated, start/stop dates, and staff member's signature
The Delegation of Authority log must capture the specific tasks delegated, effective dates, and the delegatee's signature acknowledging the delegation.
SOCRA Essential Study Documents 2
FDA Form 1572 (Statement of Investigator) must be signed by whom?