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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, Emory University tools to help you start your clinical trial research.

Audit Tools

These audit tools are available to help prepare for an upcoming audit and designed to ensure reliable and accurate clinical trials.

Self-Monitoring Tool

Self-monitoring is an important component to ensuring high quality research, especially for studies that are not routinely monitored.

Self-Monitoring 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.