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

The IRB chairperson

Answer

Both the PI and all sub-investigators

Answer

The sponsor's medical monitor

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

5 years

Answer

10 years

Answer

15 years

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 Investigator's Brochure

Answer

The protocol

Answer

The IRB approval letter

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 1571

Answer

FDA Form 1572

Answer

FDA Form 483

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

The lab director's CV

Answer

The sponsor's lab manual only

Answer

A signed confidentiality agreement

Question 6

When an investigator fails to obtain IRB approval before enrolling subjects, this constitutes:

Accepted Answer

A serious breach

Answer

A protocol deviation

Answer

A protocol violation

Answer

An adverse event

Question 7

What must be documented when an investigator delegates a study task to a site staff member?

Accepted Answer

The specific tasks delegated, start/stop dates, and staff member's signature

Answer

Only the staff member's name and date

Answer

A verbal agreement witnessed by a third party

Answer

The sponsor's written approval of that staff member