Essential Study Documents Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Essential Study Documents flashcards as text
FDA Form 1572 (Statement of Investigator) must be signed by whom?
Answer: The principal investigator only
Only the principal investigator signs FDA Form 1572, taking personal responsibility for the conduct of the study.
Under 21 CFR Part 312, how long must an investigator retain study records after the investigation is discontinued or completed?
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.
A sub-investigator joins the study after activation. What document must be updated immediately?
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.
Which financial disclosure form is required from clinical investigators under 21 CFR Part 54?
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.
Which laboratory document must be on file at an investigative site to validate clinical laboratory test results?
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.
When an investigator fails to obtain IRB approval before enrolling subjects, this constitutes:
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.
What must be documented when an investigator delegates a study task to a site staff member?
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.