Clinical Trial Resources
With all of the different federal regulations, guidance documents, sponsor requirements, and Emory policies, figuring out the basic requirements for your study can be overwhelming. We are here to help you find the answers and simplify the process. We are available to visit your site at any point from scientific concept through trial development, implementation, and analysis.
Investigator-Initiated Trials
Emory investigator-initiated trials are those trials developed, designed, and conducted by Emory University investigators. We have compiled an investigator-initiated trial management checklist and sponsor-investigator trial initiation checklist to get you started on the right path.
Clinical Trial Tools
We collaborated with the Emory Institutional Review Board and Emory Office of Compliance to develop these shared, tools to help you stay organized during the course of your study. We recommend utilizing these tools before or early in enrollment as it is very difficult to create accurate logs and other documents months after events have occurred.
Audit Tools
These audit tools are available to help prepare for an upcoming audit, monitoring visit, or self-assessment.
Self-Assessment Tool
Self-assessments ensure high quality research, especially for studies that are not routinely monitored. Self-assessments can be part of a data safety monitoring plan or performed periodically by the research team.
Self-Assessment Tool Form (.DOC)CTAC Audit Tool
Helpful tool to prepare for CTAC audits, internal reviews, or preparation for external audits.
CTAC Audit Tool Form (.DOC)Documentation
Required essential documentation for clinical trials that should be maintained in a regulatory binder for FDA-regulated clinical trials.
Documentation Form (.DOC)Regulations & Guidance, and Additional Resources
Links to federal agency guidance documents, and a list of helpful websites to federal agencies, Emory Research Support Departments, and education and training.