SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Audits, Monitoring, and Inspections 1

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?

Accepted Answer

Document the finding as a protocol deviation and notify the sponsor and IRB per protocol requirements

Answer

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?

Accepted Answer

The monitoring visit report

Answer

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?

Accepted Answer

Contact the sponsor or CRO and ask the inspector to wait while notification is made

Answer

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?

Accepted Answer

Audits are conducted by the sponsor or a third party to assess compliance; inspections are conducted by regulatory authorities with legal enforcement power

Answer

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?

Accepted Answer

Root cause analysis, corrective actions taken, preventive measures, and a timeline for completion

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates Audits, Monitoring, and Inspections 1