IND/IDE Investigator Responsibilities, Training, Education, Tools, and Resources

IND/IDE sponsor-investigators are responsible for completing all necessary IND/IDE training in order to conduct research activities. The IND/IDE Support Office provides training resources, study design consultation, and guidance regarding the FDA submission process.

Training requirements include:

• Three instructor-led modules for IND application Sponsors and Study Managers
• Three instructor-led modules for IDE application Sponsors and Study Managers
• CITI Program Training Good Clinical Practice (GCP) module

Getting Started

To get started, please contact the IND/IDE Support Office at [email protected] to request any instructor-led virtual training or consultation. Visit the CITI Program Training website in order to complete the Good Clinical Practice training module.