Audits are conducted by the Education and Compliance Support for Human Subject Research (ECS-HSR) Division at the request of the IRB and other institutional offices. The following are examples of reasons an audit may be requested:
- Concerns with a modification, continuing review or reportable new information submission,
- Complaint filed by an employee or research subject, or
- Concerns regarding the conduct of the informed consent process.
The reason for an audit dictates the extent of the review such as the number of subject records and specific data points. This decision is made on a case-by-case basis and may change as the audit progresses.
During an audit, the ECS-HSR may review the following:
- Enrollment, screening and/or randomization logs,
- Informed consent documents for enrolled subject,
- Original source documents such as
- Medical records (e.g., lab results, x-rays, MRI reports, clinical and office notes, etc.)
- Case report forms that are used to record original data
- Electronic research data (e.g., downloaded data from a mobile/wearable device, etc.)
- Study product accountability records,
- Regulatory binder/file, and
- Standard operating procedures (SOPs).
A report summarizing the audit findings is generated by the ECS-HSR and provided to the appropriate parties. Audit reports are discussed at the Compliance Activity Review Subcommittee (CARS) and/or the IRB Executive Committee.
For guidance on audits or inspections being conducted by federal regulatory agencies (e.g., FDA, NIH, DOD), visit the Human Research Protection Office, where there is also an FDA inspection checklist and helpful tips to assist in preparation.