SOCRA Audits, Monitoring, and Inspections 2 — Questions and Answers
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?
- Terminate the trial immediately at that site
- Document the findings and issue a corrective action plan requiring the PI to review all enrolled subjects (Correct answer)
- Notify the FDA before informing the investigator
- Remove all non-compliant subjects from the dataset without documentation
Correct 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.
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?
- No minimum notice is required by regulation (Correct answer)
- 24 hours
- 48 hours
- 5 business days
Correct 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.
Question 3: A for-cause audit differs from a routine audit primarily in that it is:
- Conducted by the FDA rather than the sponsor
- Triggered by a specific concern or complaint about site conduct (Correct answer)
- Required after every serious adverse event
- Performed only at the end of a trial
Correct 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.
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?
- Accept it because older versions are still valid references
- Note it as a protocol deviation and file it in the monitoring log
- Provide the current IB version, document the finding, and ensure the IRB receives the updated version (Correct answer)
- Immediately halt subject dosing until the binder is updated
Correct 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.
Question 5: Which document serves as the primary record demonstrating that a monitoring visit occurred and what was reviewed?
- The protocol deviation log
- The site initiation visit report
- The monitoring visit report (MVR) (Correct answer)
- The investigator's delegation log
Correct 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.
Question 6: An FDA inspector requests access to the sponsor's monitoring reports for a specific site. The sponsor's study team should:
- Refuse because monitoring reports are attorney-client privileged
- Provide the requested reports as FDA has authority to inspect sponsor records (Correct answer)
- Redact all CRA names before submitting
- Request a court order before complying
Correct 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.
Question 7: What is the purpose of a 'closeout' monitoring visit?
- To enroll the last subject into the study
- To ensure all trial activities are completed, documents are archived, and investigational product is reconciled (Correct answer)
- To obtain final IRB approval for the study report
- To transfer the master file to the FDA
Correct 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.
SOCRA Audits, Monitoring, and Inspections 2
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?