CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 2 — Questions and Answers
Question 1: What is the purpose of a Delegation of Authority (DoA) log in a clinical trial?
- To document sponsor payments to the site
- To record which tasks have been assigned to qualified staff by the PI (Correct answer)
- To track adverse event reports sent to the IRB
- To list all protocol amendments approved during the study
Correct 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.
Question 2: Which regulatory form is used by a sponsor to report a serious unexpected adverse reaction to the FDA during an IND study?
- Form FDA 1572
- MedWatch Form FDA 3500A
- IND Safety Report (15-day report) (Correct answer)
- Form FDA 483
Correct 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.
Question 3: What does Form FDA 1572 (Statement of Investigator) legally commit the principal investigator to?
- Agreeing to conduct the study according to the protocol and applicable regulations (Correct answer)
- Certifying that all study staff hold medical licenses
- Approving the study budget on behalf of the institution
- Submitting annual reports directly to the FDA
Correct 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.
Question 4: A sponsor monitor identifies a pattern of protocol deviations at your site. What regulatory consequence could the site face?
- Automatic participant compensation
- Placement on a clinical hold or site termination (Correct answer)
- Mandatory IRB re-approval of all prior participants
- Transfer of site data to another investigator
Correct 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.
Question 5: When must a US investigational site submit a progress report to the IRB?
- Only when a serious adverse event occurs
- At least annually, or more frequently if required by the IRB (Correct answer)
- Every six months regardless of IRB requirements
- Only at the end of the study
Correct 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.
Question 6: What is the coordinator's role when a sponsor requests a protocol deviation waiver for a specific participant?
- Approve the waiver independently and document it
- Deny the waiver to maintain protocol integrity
- Facilitate IRB notification or approval as required and document the deviation (Correct answer)
- Allow the deviation only if the sponsor provides written authorization
Correct 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.
CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 2
What is the purpose of a Delegation of Authority (DoA) log in a clinical trial?