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

To document sponsor payments to the site

Answer

To track adverse event reports sent to the IRB

Answer

To list all protocol amendments approved during the study

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

Form FDA 1572

Answer

MedWatch Form FDA 3500A

Answer

Form FDA 483

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

Certifying that all study staff hold medical licenses

Answer

Approving the study budget on behalf of the institution

Answer

Submitting annual reports directly to the FDA

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

Automatic participant compensation

Answer

Mandatory IRB re-approval of all prior participants

Answer

Transfer of site data to another investigator

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

Only when a serious adverse event occurs

Answer

Every six months regardless of IRB requirements

Answer

Only at the end of the study

Question 6

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

Accepted Answer

Facilitate IRB notification or approval as required and document the deviation

Answer

Approve the waiver independently and document it

Answer

Deny the waiver to maintain protocol integrity

Answer

Allow the deviation only if the sponsor provides written authorization