CCRA Site Initiation, Qualification, and Close-Out Procedures 3

Question 1

During a close-out visit, the CRA finds that source documents for 3 subjects are missing. What is the MOST appropriate action?

Accepted Answer

Document the finding, notify the sponsor immediately, and work with the site to locate or reconstruct documents per GCP guidelines

Answer

Missing source documents are a GCP deviation that must be documented, reported, and investigated; data fabrication is research misconduct and regulatory fraud.

Question 2

What is the purpose of a pre-study site selection visit feasibility questionnaire sent to potential sites?

Accepted Answer

To gather initial information about site capabilities, patient population, and staff resources to determine suitability

Answer

Feasibility questionnaires help sponsors efficiently screen multiple sites to identify those most likely to meet enrollment targets and protocol requirements before investing in an on-site visit.

Question 3

Which of the following statements about the informed consent process at site initiation is CORRECT?

Accepted Answer

Only the IRB-approved version of the ICF may be used to consent subjects

Answer

Only the IRB/IEC-approved, current version of the informed consent form may be used; using unapproved or outdated versions is a serious GCP and regulatory violation.

Question 4

After the Site Initiation Visit, what document does the CRA typically produce to summarize the visit findings and outstanding action items?

Accepted Answer

Site Initiation Visit Report / Follow-Up Letter

Answer

The CRA generates a visit report or follow-up letter summarizing actions taken, training completed, and any outstanding issues with assigned responsibilities and target completion dates.

Question 5

A site is being closed out after early study termination by the sponsor. The site still has 5 active subjects on treatment. What must the CRA ensure?

Accepted Answer

Subjects must be discontinued from the study drug under medical supervision with appropriate follow-up per the sponsor's instructions and IRB notification

Answer

ICH-GCP requires that when a trial is terminated early, subjects must be properly discontinued with medical oversight, appropriate follow-up, and notifications to IRBs and regulatory authorities.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Site Initiation, Qualification, and Close-Out Procedures 3