SOCRA Essential Study Documents 2

Question 1

FDA Form 1572 (Statement of Investigator) must be signed by whom?

Accepted Answer

The principal investigator only

Answer

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?

Accepted Answer

2 years

Answer

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?

Accepted Answer

The Delegation of Authority log

Answer

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?

Accepted Answer

FDA Form 3454 or 3455

Answer

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?

Accepted Answer

Normal reference ranges and lab certification/accreditation documents

Answer

Normal reference ranges and laboratory certification or accreditation documents (e.g., CLIA) must be on file to validate the clinical significance of lab results.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Essential Study Documents 2