Investigational New Drug and Device Support Program
The Investigational New Drug and Device Support Program (IND/IDE) provides support for IND/IDE protocol development and throughout a clinical trial life cycle, from start-up to closure, to investigators within the Research Institute. The IND/IDE Support Office assists study teams with the following services:
- Provides consultation to determine if an IND/ IDE is needed for proposed research;
- Offers training for protocol development/review and to navigate and operationalize study start-up, management, and closure at CHOP;
- Provides tools, templates, and guidance for obtaining and maintaining an IND/IDE clinical trial;
- Assists researchers with FDA submissions and study design questions;
- Tracks new and ongoing INDs and IDEs;
- Maintains Institutional files for all FDA correspondence.