Audit Tools
Internal self-assessments of source documents and clinical trial data are an important component to ensuring high quality research, especially for studies that are not routinely monitored. The Emory University Self-Assessment Tool is a shared tool among the Emory University Clinical Trials Audit and Compliance, Research Compliance and Regulatory Affairs, and the Institutional Review Board. We recommend someone outside the study do the assessment (e.g., a buddy system among coordinators in the same department), when possible.
Self-Assessment Tool
Self-assessments 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-assessment tool at least twice a year and more frequently in studies with high accrual or risk to participants. Consider the IRB reporting requirements for deviations during the review.
Emory University Self-Assesment 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.
Regulatory Documentation Checklist
We created a checklist for required essential documentation for clinical trials, in accordance with Good Clinical Practice. We recommend that applicable items in the checklist are maintained in a regulatory binder for all FDA-regulated and/or NIH-funded clinical trials.