Audits, Monitoring, and Inspections Flashcards

When a sponsor auditor discovers that a site has been enrolling subjects who do not meet key inclusion criteria, what is the MOST appropriate immediate action?

Answer: Document the findings and issue a corrective action plan requiring the PI to review all enrolled subjects

The auditor should document findings thoroughly and work with the site through a CAPA process, which includes the PI reviewing all enrolled subjects to assess impact.

Under 21 CFR Part 312, what is the minimum notice period a sponsor must provide to an investigator before conducting a routine site audit?

Answer: No minimum notice is required by regulation

FDA regulations do not mandate a minimum advance notice period for sponsor audits; sponsors set their own notice policies per SOPs.

A for-cause audit differs from a routine audit primarily in that it is:

Answer: Triggered by a specific concern or complaint about site conduct

For-cause audits are initiated in response to a specific signal such as data anomalies, whistleblower complaints, or unusually high enrollment rates.

During a monitoring visit, the CRA finds that the investigator's brochure (IB) version in the regulatory binder is two versions old. What should the CRA do?

Answer: Provide the current IB version, document the finding, and ensure the IRB receives the updated version

The CRA should supply the current IB, document the discrepancy as a finding, and confirm the IRB has approved the updated version as required.

Which document serves as the primary record demonstrating that a monitoring visit occurred and what was reviewed?

Answer: The monitoring visit report (MVR)

The monitoring visit report documents the date, scope, findings, follow-up actions, and confirms what source documents and data were reviewed.

An FDA inspector requests access to the sponsor's monitoring reports for a specific site. The sponsor's study team should:

Answer: Provide the requested reports as FDA has authority to inspect sponsor records

Under 21 CFR Part 312.58, the FDA has authority to inspect sponsor records including monitoring visit reports, and sponsors must provide access.

What is the purpose of a 'closeout' monitoring visit?

Answer: To ensure all trial activities are completed, documents are archived, and investigational product is reconciled

A closeout visit confirms all data are clean, investigational product is accounted for, and the site can properly archive trial records.