June 2022

All investigators from all JHU schools who seek to serve in the role of IND/IDE holder must follow the process for pre-approval through the Office of Clinical Trials (OCT) and JHM IRB prior to FDA submission.

The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program of the Office of Clinical Trials provides guidance to JHU investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.

A flowchart to outline the procedures for Investigator-held IND/IDE Review is available here.

• Sponsor-Investigators must complete the investigator qualification process through the Office of Clinical Trials and be approved to serve as an IND/IDE holder. This approval process is only required once and may be completed at any time. Click here to complete the investigator qualification survey.
• After completing the qualification process, investigators must submit a Planning Phase Application to the Johns Hopkins Medicine - Institutional Review Board (JHM eIRB) to initiate institutional review of requests to submit a new IND/IDE application. A Planning Phase Application must be approved by the Office of Clinical Trials (OCT) prior to submission to the FDA.
• Investigators should follow these step by step instructions for completion of the planning phase application.
• Each planning phase application must include the IND/IDE Supplemental Form required for eIRB planning phase applications.