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Clinical Trial Guidebook

The FDA GCP guidance incorporates the best practices for meeting the requirements of the federal regulations and will help the Investigator optimize compliance with the regulations. The purpose of this Clinical Trials Guidebook is to pull together some of the requirements of federal regulations, federal guidance, state and local laws, and Emory policies and translate them into practical instructions that are applicable to all clinical trials at Emory.

Informed Consent Process

Informed consent form, discussion, signing, and process

Learn about the Process


Eligibility requirements and maintaining eligibility

Learn about Eligibility

Ensuring Safety in Clinical Trials

Adverse Events

Documenting and reporting adverse events in a clinical trial.

Scope and Best Practices

Data and Safety Monitoring Plans

To assure the safety and welfare of subjects all clinical trials at Emory are required to have a data and safety monitoring plan (DSMP).

Required Components of DSMP

Corrective and Preventive Action Plans

How to prevent deviations and evaluate risk.

CAPA Information