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.
This form contains a list of activities for initiation and maintenance of investigator-initiated clinical studies.
Investigator-Initiated Trial Management Form (.DOC)An overview of the documents needed before the trial is open to subject screening or accrual.
Sponsor-Investigator Trial Initiation Checklist Form (.DOCX)Helpful Emory Quick Links
Clinical Trial Tools
A list of optional templates that can be modified to meet the needs of your department or trial.
Access Clinical Trial ToolsDepartment of Medicine Internal Research Resources
Support programs and resources to help faculty and postdoctoral fellows with their research endeavors.
Research Support Programs and ResourcesHitchhiker's Guide
Easily navigate the regulatory requirements in the correct order without missing an important step.
Compliances and ApprovalsInstitutional Review Board
Determine if your project requires Institutional Review Board (IRB) review.
About IRB ApprovalOffice of Research Administration Investigator's Guide
Online research administration content and tools for each stage of the grant life cycle.
About the Grant Life CycleStarting Your Clinical Trial
Initial steps and important contact information to get your clinical trial going at Emory University.
Trial Started GuideACTSI Protocol Submission
Investigators must apply to the Georgia CTSA Clinical Research Centers (GCRCs) Scientific Advisory Committee.
Protocol Application and ReviewFDA Regulated Studies
An overview on the Food and Drug Administration (FDA) and FDA inspection preparation.
FDA Clinical Trial ComplianceNewcomer's Guide
A helpful guide to research administration that covers various aspects of grant preparation.
Research Administration FAQs