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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.

Download the Clinical Trials Guidebook 

Approvals, Training, and Documentation

Checklist

To ensure a successful clinical study, we’ve compiled a list of the necessary documents and things needed before a study can be started.

Required Approvals

Brief descriptions of the required approvals at Emory

Emory Training Requirements

Choose the training below that is appropriate for your clinical trial.

Essential Documentation

A list of essential documents that must be gathered, maintained, and periodically reviewed.

Informed Consent Process

Informed consent form, discussion, signing, and process

Learn about the Process

Eligibility

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

Organization, Reporting, and Changes

Organizational Logs

Clinical trial sponsors will often supply logs to the study team to use as supporting documentation to the case report forms or as the actual case report forms.

Reporting Requirements

Each sponsor has unique reporting requirements for events that occur during the clinical trial and that need to be reported to the sponsor by individual site PIs.

Case Report Forms

Case report forms (CRFs) are the last point of data entry in a clinical trial, and proper development and completion can affect study success.

Study Team Changes

Information on what data, documentation, or items that need to be submitted due to a change in study team members or principal investigators.