Audit Tools


Self-monitoring is an important component to ensuring high quality research, especially for studies that are not routinely monitored. The Emory University Self-Monitoring Tool is a shared tool among the Emory University Clinical Trials Audit and Compliance, Office of Compliance, and the Institutional Review Board. We recommend someone outside the study do the monitoring (e.g., a buddy system among coordinators in the same department), when possible.

Self-Monitoring Tool

Self-monitoring should be implemented in studies not otherwise monitored by sponsors or contract research organizations. These are most commonly investigator-initiated studies but also include some foundation and federally-funded projects. Use the self-monitoring tool at least twice a year and more frequently in studies with high accrual or risk to subjects.  Please send your completed self-monitoring reports to the CTAC listserv at ctcompliance@emory.edu and consider the IRB reporting requirements for deviations for which you become aware.

Download the Self-Monitoring Tool

CTAC Audit Tool

We created a user-friendly checklist of the CTAC REDCap checklist that we use for our quality assurance reviews.  This tool can be used not only to prepare for CTAC reviews, but also for your own internal reviews or preparation for external audits.

Download the Audit Tool

Regulatory Documentation Checklist

We created a checklist for required essential documentation for clinical trials, in accordance with Good Clinical Practice. We advise that all items in the checklist are maintained in a regulatory binder for all FDA-regulated clinical trials.

Download the Documentation Checklist