Training Program Title
Worksheet: Audit Readiness
CTSA Hub Administered
Training Program Description
Having plans in place to outline procedures, documentation and key roles and responsibilities is vital when preparing for an FDA audit.
One way your site can prepare is to develop an audit-readiness checklist. This provides a guide for staff to use to ensure your processes are followed.
The audit readiness checklist includes:
- Collecting info for your inspection
- Notifying key staff
- Preparing your site for an audit
- Gathering and delivering documents
Clinical research, Clinical trial, Audits, Monitoring
Digital Commons Disciplines
Cost to Access
Study and Site Management
Principal Investigators; Clinical Research Professionals (other than PI)