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

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

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

During a close-out visit, the sponsor's CRA reconciles investigational product, ensures all data queries are resolved, and confirms the site's documentation is ready for archiving.

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

Answer: Stop all study-related interventions and enrollment as directed

A clinical hold requires the site to immediately suspend enrollment and interventions as directed by the sponsor pending FDA resolution of the safety concern.

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

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

Under 21 CFR 312.62, investigators must retain records for at least 2 years after the last marketing application approval, or if no application is filed, 2 years after study discontinuation.

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

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

Altering data without source documentation is data falsification, a serious GCP violation; the coordinator must refuse and escalate to the PI and IRB.

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

Answer: To independently verify that GCP and protocol requirements are being followed

Sponsor audits are independent evaluations that verify site compliance with GCP, the protocol, and applicable regulations, separate from routine monitoring.

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

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

FDAAA 801 requires applicable clinical trials to be registered on ClinicalTrials.gov no later than 21 days after enrolling the first participant, but best practice is prior to first enrollment.