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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
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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.

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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?

Select the compliance status.

To ensure adherence to Good Clinical Practice standards.
2
Describe any data integrity issues identified during the audit.

Provide details of any data integrity issues.

To assess the quality and reliability of clinical trial data.
3
How many patient safety incidents were reported?

Enter the number of reported incidents.

To evaluate safety protocols and patient protection measures.
Min: 0
Target: 0
Max: 100
4
Is the site compliant with regulatory requirements?

Select the regulatory compliance status.

To verify compliance with applicable regulations.
5
What are the key observations made during the audit?

Please provide detailed observations.

To document any significant findings or concerns.

6
Has source data been verified for accuracy?

Select the verification status.

To ensure that clinical data reflects the source documents accurately.
7
How many data entry errors were identified?

Enter the number of errors found.

To assess the quality of data entry processes.
Min: 0
Target: 0
Max: 50
8
Is the audit trail for data changes available?

Indicate if the audit trail is available.

To confirm that changes to data can be tracked and reviewed.
9
What corrective actions have been taken to address previous findings?

Describe the corrective actions implemented.

To ensure that past issues have been resolved effectively.
10
When was the last data review conducted?

Select the date of the last review.

To track the frequency of data reviews and ensure ongoing quality.

11
Is the informed consent process compliant with regulations?

Select the compliance status of the informed consent process.

To ensure that participants fully understand the trial and their rights.
12
How many adverse event reports were filed?

Enter the total number of adverse events reported.

To evaluate the safety monitoring of participants during the trial.
Min: 0
Target: 0
Max: 100
13
Is there a safety monitoring plan in place?

Indicate if a safety monitoring plan exists.

To confirm that participant safety is actively monitored throughout the trial.
14
Describe the mechanism for collecting participant feedback.

Provide details about the feedback collection method.

To ensure that participants can express concerns or suggestions regarding their safety.
15
When was the last training for staff on participant protection conducted?

Select the date of the last training session.

To ensure that staff are up-to-date on best practices for participant protection.

16
Is the site management compliant with established protocols?

Select the compliance status of site management.

To ensure that site operations align with protocol requirements.
17
What is the staff turnover rate at the site?

Enter the percentage of staff turnover.

To assess the stability and experience of the site staff.
Min: 0
Target: 0
Max: 100
18
Are emergency protocols established and communicated?

Indicate if emergency protocols are in place.

To ensure preparedness for any emergencies during the trial.
19
Describe the communication plan for stakeholders.

Provide details about the communication strategy.

To ensure transparency and effective communication among all parties involved.
20
When was the last site evaluation conducted?

Select the date of the last evaluation.

To track the frequency of site evaluations for ongoing compliance.

21
Is the documentation for protocol adherence complete?

Select the documentation status.

To verify that all protocol deviations are properly documented.
22
How many essential documents are missing?

Enter the number of missing documents.

To assess the completeness of essential trial documentation.
Min: 0
Target: 0
Max: 50
23
Is there a version control system in place for trial documents?

Indicate if version control is implemented.

To ensure that the latest versions of documents are being used.
24
Describe the process for reviewing trial documentation.

Provide details about the documentation review process.

To ensure that documentation is regularly reviewed for accuracy and compliance.
25
When was the last documentation audit performed?

Select the date of the last audit.

To track the frequency of documentation audits for compliance.

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

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