Single logo
LoginSign Up

Clinical Trial Site Audit Checklist

A comprehensive checklist for auditing clinical trial sites to ensure compliance with regulatory standards, data integrity, and patient safety in pharmaceutical research.

Clinical Trial Site Audit Checklist

by: audit-now
4.2

Get Template

About This Checklist

The Clinical Trial Site Audit Checklist is an essential tool for ensuring compliance, quality, and safety in pharmaceutical research. This comprehensive checklist addresses key aspects of clinical trial management, from protocol adherence to data integrity, helping to streamline the audit process and maintain regulatory standards. By utilizing this checklist, pharmaceutical companies can enhance their clinical trial operations, mitigate risks, and improve overall research outcomes.

Learn more

Industry

Healthcare

Standard

ICH GCP E6(R2) - Good Clinical Practice

Workspaces

Research Facilities

Occupations

Clinical Research Associate
Quality Assurance Auditor
Clinical Trial Manager
Regulatory Affairs Specialist
Clinical Operations Director
1
Is the site compliant with GCP guidelines?
2
Describe any data integrity issues identified during the audit.
3
How many patient safety incidents were reported?
Min: 0
Target: 0
Max: 100
4
Is the site compliant with regulatory requirements?
5
What are the key observations made during the audit?
6
Has source data been verified for accuracy?
7
How many data entry errors were identified?
Min: 0
Target: 0
Max: 50
8
Is the audit trail for data changes available?
9
What corrective actions have been taken to address previous findings?
10
When was the last data review conducted?
11
Is the informed consent process compliant with regulations?
12
How many adverse event reports were filed?
Min: 0
Target: 0
Max: 100
13
Is there a safety monitoring plan in place?
14
Describe the mechanism for collecting participant feedback.
15
When was the last training for staff on participant protection conducted?
16
Is the site management compliant with established protocols?
17
What is the staff turnover rate at the site?
Min: 0
Target: 0
Max: 100
18
Are emergency protocols established and communicated?
19
Describe the communication plan for stakeholders.
20
When was the last site evaluation conducted?
21
Is the documentation for protocol adherence complete?
22
How many essential documents are missing?
Min: 0
Target: 0
Max: 50
23
Is there a version control system in place for trial documents?
24
Describe the process for reviewing trial documentation.
25
When was the last documentation audit performed?

FAQs

The checklist covers key areas such as protocol compliance, informed consent procedures, investigator qualifications, drug accountability, data management, and safety reporting.

The frequency of audits may vary depending on the study's complexity and duration, but typically, sites should be audited at least once during the course of a trial, with more frequent audits for high-risk or complex studies.

Clinical trial site audits are usually conducted by qualified auditors from the sponsor company, contract research organizations (CROs), or independent auditing firms specializing in pharmaceutical research.

Non-compliance issues can lead to corrective and preventive actions (CAPAs), suspension of patient enrollment, or in severe cases, termination of the site's participation in the trial and potential regulatory actions.

By providing a structured approach to evaluating all aspects of clinical trial conduct, this checklist helps identify areas for improvement, ensures consistency across sites, and promotes adherence to regulatory requirements and industry best practices.

Benefits of Clinical Trial Site Audit Checklist

Ensures compliance with Good Clinical Practice (GCP) guidelines

Improves data quality and integrity in clinical trials

Enhances patient safety and protection

Streamlines the audit process for increased efficiency

Helps identify and address potential issues before they escalate