Which term is a written evaluation by the sponsor's auditor of the results of the audit?

Prepare for the ICH Good Clinical Practice (GCP) Exam for Certified Clinical Research Coordinator with engaging multiple-choice questions and detailed explanations. Elevate your understanding and expertise to excel in your certification exam!

Multiple Choice

Which term is a written evaluation by the sponsor's auditor of the results of the audit?

Explanation:
In GCP, after an audit is completed, the sponsor’s auditor prepares a formal written evaluation of the audit’s findings, conclusions, and recommendations. This document is called an Audit Report. It serves as the official record of what was reviewed, what was found in terms of regulatory compliance and data integrity, and what actions are suggested to address any issues (often a corrective and preventive action plan). The other terms refer to different things: an audit is the activity itself; an audit trail is the chronological record of data changes in the system; an audit certificate is not the written evaluation of the audit results.

In GCP, after an audit is completed, the sponsor’s auditor prepares a formal written evaluation of the audit’s findings, conclusions, and recommendations. This document is called an Audit Report. It serves as the official record of what was reviewed, what was found in terms of regulatory compliance and data integrity, and what actions are suggested to address any issues (often a corrective and preventive action plan). The other terms refer to different things: an audit is the activity itself; an audit trail is the chronological record of data changes in the system; an audit certificate is not the written evaluation of the audit results.

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