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

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

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

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

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

Answer: IND Safety Report (15-day report)

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.

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

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

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.

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

Answer: Placement on a clinical hold or site termination

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.

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

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

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

What is the coordinator's role when a sponsor requests a protocol deviation waiver for a specific participant?

Answer: Facilitate IRB notification or approval as required and document the deviation

Protocol deviations must be documented, reported to the IRB per its requirements, and communicated to the sponsor regardless of whether a waiver is sought.