An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. This authorization must be secured prior to administration of any new drug, biological product that is not the subject of an approved New Drug Application, or Biologics/Product License Application. An IND may be required for a clinical investigation using a marketed drug for a use other than the indications in the approved labeling. FDA provides this guidance for Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.
The Office of Compliance can assist investigators, coordinators and the Emory research community in determining which regulations apply to the research along with providing education and consultation regarding regulatory requirements, compliance obligations and best practices for Sponsor Investigators. Please contact us at (404) 727-2398 or firstname.lastname@example.org for assistance with determination of IND requirements, submission of the IND application, or maintenance of the IND.
Guidance for Emory Sponsors and Sponsor-Investigators includes information on IRB submission of S-I studies including Continuing Review and amendments. When the IRB identifies a study as one having an Emory investigator as S-I, the S-I will be referred to the Office of Compliance for training about specific S-I responsibilities. The S-I will be requested to complete the appropriate Emory S-I IND Responsibility Checklist.
- S-I IND Responsibilities Checklist
- S-I IND Responsibilities Checklist Continuing Review Update
- S-I IND Responsibilities Checklist Multi-site Trials
The Office of Compliance provides one-on-one consultations regarding the following topics:
- IND requirement determination: Click here for FDA Guidance on IND determination
- IND submission: Click here for information including submission forms and templates
- Protocol review: Click here for NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies
- Study start-up: Click here for checklist
- SOP development: click here for sample SOPs
- Expanded Access (Compassionate/Treatment Use)
- IND communications
- Annual Reports: Click here for Annual report template
- Safety Reports: Click here for Adverse Event Assessment Form
- IND Amendment: Click here for submission information and templates
- IND Transfer: Click here for IND transfer information and templates
- IND Withdrawal: Click here for IND withdrawal request template
- IND Expanded Access Withdrawal: Click here for Expanded Access IND withdrawal request template
- Audit/FDA inspection preparation
If you have questions or would like to discuss topics related to investigator-initiated research, please contact us at (404) 727-2398 or email@example.com.