IND/IDE Policy

Policy Statement

The translation of scientific discovery to clinical practice is core to the mission of the Johns Hopkins University (“JHU” or “University”). Where qualified faculty, with appropriate training and support, wish to translate discoveries to approved treatments, they may serve as the “Sponsor-Investigator” of a Food and Drug Administration (“FDA”) clinical investigation under this policy.

Who Is Governed By These Guidelines?

All units of the University, but not including The Johns Hopkins University Applied Physics Laboratory, are governed by this Policy.

Purpose

This policy maintains the University’s compliance with FDA regulations and ensures appropriate support for investigators engaged in translational research involving FDA-regulated clinical investigational items (whether a drug, device, biologic or combination).

How To:	Step 1: IND/IDE Holder Review Sponsor-Investigators must complete the investigator qualification process and be approved to serve as an IND/IDE holder. This approval process is only required once and may be completed at any time via the investigator qualification survey. Step 2: Planning Phase Application Sponsor-Investigators (IND/IDE holders) must submit a Planning Phase Application through 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.
Resources:	Helpful Links Investigational New Drug (IND)/ Investigational Device Exemption (IDE) Regulatory Program (hopkinsmedicine.org) Requirements for JHU Investigator-Held INDs/IDEs (hopkinsmedicine.org) Additional Information: Sets forth qualifications for investigators who wish to serve as IND/IDE sponsor Creates a mandatory registration process prior to filing new INDs/IDEs after the effective date Helps support new COI policy [In effect Jan 2021]- prohibits individuals with IP interests/significant financial interests from serving as sponsor-investigator Does not apply to single patient/compassionate use requests Does not apply to IND/IDE applications submitted to the FDA prior to this date Applies to all JHU investigators- not just JHM Office of Clinical Trials is responsible for operationalizing this policy
Contacts:	Schedule a Consultation: https://outlook.office365.com/owa/calendar/INDIDERegulatoryProgram@live.johnshopkins.edu/bookings/ For questions email: IND_IDEprogram@jh.edu
Related Links:	Research Misconduct

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