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Exam ACRP-CP Topic 1 Question 91 Discussion

Actual exam question for ACRP's ACRP-CP exam
Question #: 91
Topic #: 1
What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

Suggested Answer: C Vote an answer

An audit is a systematic and independent examination of trial-related activities and documents. Its purpose is to determine whether the study was conducted in compliance with the protocol, GCP, and regulatory requirements. Audits are usually performed by the sponsor or an independent auditor and focus on evaluating data integrity and trial conduct.
GCP guidelines define an audit as a thorough examination to ensure adherence to protocol and regulatory requirements.
"An audit is a systematic and independent examination of trial-related activities to verify compliance with the protocol and regulatory standards." Objectives:
Ensure compliance and data integrity.
Identify any gaps in trial conduct.

by Vicky at Jul 24, 2026, 06:23 AM

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