CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 2

Question 1

What is the purpose of a Delegation of Authority (DoA) log in a clinical trial?

Accepted Answer

To record which tasks have been assigned to qualified staff by the PI

Answer

The DoA log documents that the PI has formally assigned specific trial tasks to qualified, trained staff members and is a key GCP requirement.

Question 2

Which regulatory form is used by a sponsor to report a serious unexpected adverse reaction to the FDA during an IND study?

Accepted Answer

IND Safety Report (15-day report)

Answer

Sponsors must submit IND Safety Reports (expedited 15-day or 7-day reports) to the FDA for unexpected serious adverse reactions under 21 CFR 312.32.

Question 3

What does Form FDA 1572 (Statement of Investigator) legally commit the principal investigator to?

Accepted Answer

Agreeing to conduct the study according to the protocol and applicable regulations

Answer

By signing Form FDA 1572, the investigator commits to conducting the trial per the protocol, GCP, and relevant FDA regulations including recordkeeping and reporting obligations.

Question 4

A sponsor monitor identifies a pattern of protocol deviations at your site. What regulatory consequence could the site face?

Accepted Answer

Placement on a clinical hold or site termination

Answer

Repeated or serious protocol deviations can lead the sponsor or FDA to place the site on clinical hold or terminate its participation to protect trial integrity.

Question 5

When must a US investigational site submit a progress report to the IRB?

Accepted Answer

At least annually, or more frequently if required by the IRB

Answer

Under 21 CFR 56.108, sites must submit continuing review reports to the IRB at least annually to maintain approval for ongoing studies.

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC - Certified Clinical Research Coordinator Practice Test

CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 2