Investigator-Initiated Trials

Emory investigator-initiated trials are those trials developed, designed, and conducted by Emory University investigators. Maintaining compliance can be a challenge since these trials are not overseen by a sponsor and monitoring team.

Investigator-Initiated Trial Management Form

This form contains a list of activities for initiation and maintenance of investigator-initiated clinical studies.

Investigator-Initiated Trial Management Form (.DOC)
Sponsor-Investigator Trial Initiation Checklist

An overview of the documents needed before the trial is open to subject screening or accrual.

Sponsor-Investigator Trial Initiation Checklist Form (.DOCX)

Clinical Trial Tools

A list of optional templates that can be modified to meet the needs of your department or trial.

Access Clinical Trial Tools

Department of Medicine Internal Research Resources

Support programs and resources to help faculty and postdoctoral fellows with their research endeavors.

Research Support Programs and Resources

Hitchhiker's Guide

Easily navigate the regulatory requirements in the correct order without missing an important step.

Compliances and Approvals

Institutional Review Board

Determine if your project requires Institutional Review Board (IRB) review.

About IRB Approval

Office of Research Administration Investigator's Guide

Online research administration content and tools for each stage of the grant life cycle.

About the Grant Life Cycle

Starting Your Clinical Trial

Initial steps and important contact information to get your clinical trial going at Emory University.

Trial Started Guide

ACTSI Protocol Submission

Investigators must apply to the Georgia CTSA Clinical Research Centers (GCRCs) Scientific Advisory Committee.

Protocol Application and Review

FDA Regulated Studies

An overview on the Food and Drug Administration (FDA) and FDA inspection preparation.

FDA Clinical Trial Compliance

Newcomer's Guide

A helpful guide to research administration that covers various aspects of grant preparation.

Research Administration FAQs