Investigational New Drug Application (IND) Process Overview

Introduction

A CTSA Consortium IND IDE Taskforce was formed to focus on enhancing CTSA capabilities to support faculty who were (or were considering becoming) sponsor-investigators. The materials on this website are made available by the members of the IND/IDE taskforce.

As a consequence of investigator-initiated clinical research involving drugs and/or devices, there are numerous institutional considerations to ensure that investigators and their research staffs are appropriately equipped to manage all aspects of the regulatory responsibilities and obligations associated with initiating and conducting such research.

Summary of IND and IDE Regulations pertinent to the Sponsor-Investigators (From Hartman et al “IND/IDE support for Investigator-Initiated Clinical Research: The Clinical Translational Science Award (CTSA) Experience”)

Please click on any one of the numbers or text on the right in order to advance to the coresponding step in the process.