CCRC CCRC - Certified Clinical Research Coordinator Sponsor and Regulatory Relationships Questions and Answers 3

Question 1

Which of the following best describes a 'close-out visit' conducted by a sponsor?

Accepted Answer

A visit to reconcile drug supplies, archive documents, and verify study completion

Answer

A visit to enroll the last participant

Answer

A visit to conduct a final IRB inspection

Answer

A visit to announce study results to site staff

Question 2

If a sponsor places a study on clinical hold, what must the site immediately do?

Accepted Answer

Stop all study-related interventions and enrollment as directed

Answer

Continue enrollment until official written notice is received

Answer

Transfer all participants to an alternative study

Answer

Archive all records and terminate IRB approval

Question 3

How long must US clinical trial records generally be retained after study completion under FDA regulations?

Accepted Answer

At least 2 years after the last marketing application approval or the study is discontinued

Answer

2 years

Answer

5 years

Answer

10 years

Question 4

A sponsor asks the coordinator to change data in the EDC without a corresponding source document correction. What should the coordinator do?

Accepted Answer

Refuse and report the request to the PI and IRB as a potential GCP violation

Answer

Make the change as requested to keep the sponsor satisfied

Answer

Make the change and note it as sponsor-directed

Answer

Ask the participant to sign a new consent form first

Question 5

What is the primary purpose of a sponsor's audit of a clinical trial site?

Accepted Answer

To independently verify that GCP and protocol requirements are being followed

Answer

To determine whether additional funding is needed

Answer

To replace the routine monitoring visit

Answer

To interview participants about their experience

Question 6

When should a US clinical trial site register its study on ClinicalTrials.gov?

Accepted Answer

Before enrollment of the first participant, as required by FDAAA 801

Answer

Only after the study is completed

Answer

Within 30 days of IRB approval

Answer

When the sponsor requests it