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

Accept the data as is and proceed with close-out since the subjects have completed the study

Answer

Fabricate the missing source documents based on CRF entries

Answer

Exclude the subjects' data from all analyses without documentation

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

To collect subject consent before the trial begins

Answer

To finalize the statistical analysis plan with site investigators

Answer

To obtain regulatory approvals from the FDA

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

Subjects may be enrolled using a draft ICF pending final IRB approval

Answer

The CRA may consent subjects if the PI is unavailable

Answer

The ICF does not need to be reviewed at the initiation visit if it was approved during site qualification

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

Serious Adverse Event Report

Answer

Protocol Deviation Log

Answer

Statistical Analysis Plan

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

Subjects must immediately discontinue treatment without any follow-up

Answer

Subjects may continue using the investigational product indefinitely at their own risk

Answer

The CRA makes independent decisions about subject care without consulting the sponsor

Question 6

Which of the following is considered an essential document that must be in the investigator's file at the time of site initiation?

Accepted Answer

A signed copy of the protocol and all amendments with the date of signature

Answer

The completed final clinical study report

Answer

The final regulatory submission package for NDA

Answer

Copies of all randomization codes for all subjects

Question 7

During a site close-out visit, the CRA confirms all queries are resolved. What is the FINAL step before the site is officially closed?

Accepted Answer

The site is notified in writing that close-out is complete and records must be archived for the required retention period

Answer

The CRA collects all IRB correspondence and destroys it

Answer

The PI submits a new IND for a follow-up study

Answer

The CRA transfers all site data to another active clinical site