SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Audits, Monitoring, and Inspections 1 — Questions and Answers
Question 1: During a site monitoring visit, the Clinical Research Associate (CRA) discovers that several informed consent forms are missing the date the participant signed. What is the most appropriate immediate action?
- Backdate the consent forms to match the enrollment date
- Document the finding as a protocol deviation and notify the sponsor and IRB per protocol requirements (Correct answer)
- Ask the investigator to have participants re-sign the forms with today's date without documentation
- Ignore the finding if the participant is still active on the study
Correct answer: Document the finding as a protocol deviation and notify the sponsor and IRB per protocol requirements
Missing consent dates are a protocol deviation that must be documented and reported to the sponsor and IRB according to protocol and regulatory requirements. Backdating or undocumented corrections would constitute data falsification.
Question 2: Which document serves as the primary tool a CRA uses to guide and record findings during a routine monitoring visit?
- The investigator brochure
- The monitoring visit report (Correct answer)
- The informed consent template
- The protocol amendment log
Correct answer: The monitoring visit report
The monitoring visit report (MVR) is the formal record the CRA completes to document observations, findings, outstanding issues, and follow-up actions from each site visit. It serves as the official communication between the CRA and the sponsor.
Question 3: An FDA inspector arrives unannounced at a clinical investigator's site. What should the site staff do first?
- Refuse entry until legal counsel is present
- Contact the sponsor or CRO and ask the inspector to wait while notification is made (Correct answer)
- Begin shredding any documents that might reflect poorly on the site
- Immediately grant full access to all study files without notifying anyone
Correct answer: Contact the sponsor or CRO and ask the inspector to wait while notification is made
Sites should notify the sponsor or CRO as quickly as possible when an FDA inspection occurs. The inspector can be politely asked to wait briefly while the principal investigator and sponsor are notified, which is standard industry practice and does not obstruct the inspection.
Question 4: What is the primary distinction between a sponsor audit and an FDA inspection of a clinical trial site?
- Audits are mandatory by law; inspections are voluntary quality checks
- Audits are conducted by the sponsor or a third party to assess compliance; inspections are conducted by regulatory authorities with legal enforcement power (Correct answer)
- Inspections are conducted by the IRB; audits are conducted by the FDA
- There is no meaningful difference — both result in FDA warning letters if issues are found
Correct answer: Audits are conducted by the sponsor or a third party to assess compliance; inspections are conducted by regulatory authorities with legal enforcement power
A sponsor audit is an internal quality assurance activity without regulatory enforcement authority, while an FDA inspection is a government activity that can result in regulatory actions including warning letters, clinical holds, or import alerts.
Question 5: A CAPA plan developed after an audit finding should include which of the following components?
- Only a description of the problem identified
- Root cause analysis, corrective actions taken, preventive measures, and a timeline for completion (Correct answer)
- A list of personnel who will be terminated due to the finding
- A request to the FDA to waive the finding
Correct answer: Root cause analysis, corrective actions taken, preventive measures, and a timeline for completion
An effective CAPA plan must address the root cause of the problem, describe immediate corrective actions to fix current issues, outline preventive actions to stop recurrence, and provide a realistic timeline for implementation and verification of effectiveness.
Question 6: During source data verification (SDV), a CRA finds that the hemoglobin value recorded in the case report form (CRF) does not match the laboratory report in the medical record. What is the correct course of action?
- Correct the CRF entry directly without documentation
- Ask the site staff to make a corrected entry in the CRF following GCP guidelines — crossing out the error, entering the correct value, dating, and initialing — and document the discrepancy in the monitoring visit report (Correct answer)
- Accept the CRF value as correct since it was entered by the investigator
- Delete the laboratory result from the source document to eliminate the discrepancy
Correct answer: Ask the site staff to make a corrected entry in the CRF following GCP guidelines — crossing out the error, entering the correct value, dating, and initialing — and document the discrepancy in the monitoring visit report
GCP requires that any CRF correction be made by striking through the error, writing the correct value, and having the person making the correction date and initial it. The CRA must also document this discrepancy finding in the monitoring visit report.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Audits, Monitoring, and Inspections 1
During a site monitoring visit, the Clinical Research Associate (CRA) discovers that several informed consent forms are missing the date the participant signed.
What is the most appropriate immediate action?