SOCRA Knowledge 2

Question 1

Under FDA regulations, how long must clinical trial records be retained?

Accepted Answer

2 years after the last approval of a marketing application

Answer

Per 21 CFR 312.62, investigators must retain records for 2 years after the last approval of a marketing application or 2 years after investigation is discontinued.

Question 2

What is the primary function of a Data Safety Monitoring Board (DSMB)?

Accepted Answer

To independently monitor participant safety and study data integrity during a trial

Answer

A DSMB is an independent committee that monitors safety data and study conduct, with the authority to recommend modifications or termination.

Question 3

What is the purpose of an audit trail in electronic data systems?

Accepted Answer

To provide a secure, computer-generated record of all data changes with timestamps

Answer

An audit trail is a secure, computer-generated, time-stamped electronic record that allows reconstruction of events related to data creation, modification, and deletion.

Question 4

What is a protocol deviation versus a protocol violation?

Accepted Answer

A deviation is any departure from the protocol; a violation is a deviation that affects safety or data integrity

Answer

A deviation is any unplanned departure from the protocol, while a violation is a significant deviation that may affect participant safety, rights, or data integrity.

Question 5

What is the Belmont Report and why is it significant?

Accepted Answer

It identifies basic ethical principles for human subjects research: respect, beneficence, and justice

Answer

The Belmont Report (1979) identifies three core ethical principles: respect for persons, beneficence, and justice.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Knowledge 2