Study Self-Audit Tool

The tool is designed to review the records of a single research participant.

Before starting the audit, record the:

• Study number
• Subject ID
• Date of the audit

The tool includes questions that assess whether:

• The participant was recruited, screened, enrolled, and consented according to the IRB-approved protocol.
• Eligibility requirements were met and documented.
• Safety reviews, adverse events, and reporting requirements were completed appropriately.
• Study data are complete, accurate, and consistent with source documentation.
• Study visits, assessments, and procedures were conducted according to the protocol.
• Protocol deviations, missed procedures, withdrawals, or other issues were properly documented.

For FDA-regulated or Good Clinical Practice (GCP) studies, the tool also includes questions related to:

• Investigational product accountability and administration.
• Source documentation requirements.
• Delegation of study responsibilities.

The tool may be customized with additional study-specific questions as needed.

After completing the review, sign and date the form and document any findings along with corrective actions.

The Study Self-Audit Tool can be used in a variety of situations to help investigators assess study conduct and documentation, including:

• As part of routine study oversight. For studies that rely on Principal Investigator monitoring, the tool can be used periodically (for example, annually) to document monitoring activities and verify ongoing compliance with the IRB-approved protocol.
• To prepare for an audit, monitoring visit, or FDA inspection. Conducting a self-audit before an external review can help identify and correct issues before they are identified by auditors, monitors, or regulators.
• When assuming responsibility for an existing study. A newly appointed Principal Investigator can use the tool to assess the condition of study records and documentation before taking over responsibility for the protocol.
• When concerns arise about study conduct or documentation. The tool can help identify missing documentation, protocol deviations, data inconsistencies, or other issues that may require corrective action.

Regular use of the tool can help research teams maintain accurate study records, identify potential compliance issues early, and support high-quality research conduct.