New Tools Available: Study Self-Audit Tool and CITIHub

The new Study Self-Audit Tool is now available on the OHSRP website.

This tool helps investigators and study teams review study records and procedures for compliance with the IRB-approved protocol. It provides a structured checklist for evaluating documentation and study conduct for an individual research participant and can help identify and correct issues before they become larger problems.

The tool may be particularly useful:

• As part of routine study oversight and monitoring activities
• To prepare for an audit, monitoring visit, or FDA inspection
• When a new Principal Investigator assumes responsibility for an existing study
• When concerns arise regarding study documentation or protocol compliance

The self-audit covers key areas of study conduct, including recruitment and informed consent, eligibility and safety oversight, data collection and source documentation, and protocol compliance. For FDA-regulated and Good Clinical Practice (GCP) studies, the tool also includes additional questions related to investigational product accountability and source documentation requirements.

The tool is intended to be flexible and can be supplemented with study-specific questions as needed.

Regular use of the Study Self-Audit Tool can help research teams maintain high-quality study records, identify potential compliance issues early, and ensure they are well prepared for audits, monitoring visits, or inspections.

Access the tool: Study Self-Audit Tool

NCI Center for Cancer Research has also launched CITIHub, a new website that allows NIH staff to quickly verify completed CITI training.

Using CITIHub, you can:

• Search for NIH staff members and view completed CITI training courses
• Download CITI completion certificates for regulatory files
• Verify training status without requesting certificates from study team members

This resource is intended to simplify training documentation and make it easier for study teams to maintain complete regulatory records.

Access CITIHub: The link is available on the NIH CITI Training webpage.