SOCRA Audits, Monitoring, and Inspections 2

Question 1

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?

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

No minimum notice is required by regulation

Answer

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

Question 3

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

Accepted Answer

Triggered by a specific concern or complaint about site conduct

Answer

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

Question 4

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?

Accepted Answer

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

Answer

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

Question 5

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

Accepted Answer

The monitoring visit report (MVR)

Answer

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

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Audits, Monitoring, and Inspections 2