Clinical Trial Audit Checklist

Use the Clinical Trial Audit Checklist to verify protocols, Good Clinical Practice (GCP), and regulatory requirements for data integrity and subject safety.

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Clinical Trial Audit Checklist

Study Setup & Documentation Review

Participant Consent & Eligibility

Investigational Product (IP) Management

Trial Conduct, Safety & Data Integrity

Reporting & Follow-up

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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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Clinical Trial Audit Checklist

Use the Clinical Trial Audit Checklist to verify protocols, Good Clinical Practice (GCP), and regulatory requirements for data integrity and subject safety.

1. Has the clinical trial been formally selected for audit?

2. Has the Clinical Trial Protocol been reviewed to ensure all necessary sections are included and align with the trial objectives?

3. Is the protocol compliant with the necessary guidelines and regulations?

4. Are all required documents, such as Case Report Forms (CRFs) and study records, available and complete as per regulations?

5. Has the Data Management Plan been reviewed to ensure data integrity, confidentiality, security measures, and quality (e.g., storage, backup, access controls, archiving)?

6. Is there a clear process for trial termination that ensures all necessary approvals are obtained?

1. Have the patient consent forms been reviewed to confirm they are comprehensive, clearly written, and meet all legal and ethical requirements?

2. Are the consent forms signed and dated by the patient and reviewed by the ethics board?

3. Is the informed consent process documented appropriately?

4. Have participant eligibility criteria (e.g., age, gender, medical history, inclusion, and exclusion) been verified to ensure only eligible patients are enrolled?

1. Has the Clinical Investigational Product (IP) been inspected to ensure it is of high quality and meets necessary standards (e.g., packaging and labeling)?

2. Is the IP readily available when needed?

3. Is the IP stored at the correct temperature and humidity (storage conditions)?

1. Are all trial procedures being followed as per protocol?

2. Are there any deviations from the approved protocol?

3. Has the adherence to the clinical trial protocol and procedures been monitored (e.g., treatment administration, data collection, follow-up procedures)?

4. Is the collected data complete, accurate, and reliable (e.g., no outliers or missing data)?

5. Are adverse events being properly documented, reported, and managed in a timely manner according to reporting requirements?

6. Are there appropriate mechanisms in place to ensure participant safety?

1. Does the final clinical trial report accurately and comprehensively summarize the trial results and conclusions?

2. Have all identified issues or concerns from the audit been addressed with corrective actions?

3. Are there any outstanding concerns requiring further investigation or corrective action?

4. Has the audit report been prepared to summarize findings and recommendations?

5. Have the audit findings been presented clearly and effectively to all relevant stakeholders?