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

Terminate the trial immediately at that site

Answer

Notify the FDA before informing the investigator

Answer

Remove all non-compliant subjects from the dataset without documentation

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

24 hours

Answer

48 hours

Answer

5 business days

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

Conducted by the FDA rather than the sponsor

Answer

Required after every serious adverse event

Answer

Performed only at the end of a trial

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

Accept it because older versions are still valid references

Answer

Note it as a protocol deviation and file it in the monitoring log

Answer

Immediately halt subject dosing until the binder is updated

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 protocol deviation log

Answer

The site initiation visit report

Answer

The investigator's delegation log

Question 6

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

Accepted Answer

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

Answer

Refuse because monitoring reports are attorney-client privileged

Answer

Redact all CRA names before submitting

Answer

Request a court order before complying

Question 7

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

Accepted Answer

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

Answer

To enroll the last subject into the study

Answer

To obtain final IRB approval for the study report

Answer

To transfer the master file to the FDA