In This Section
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 Managers
- Three instructor-led modules for IDE application Sponsors and Managers
- CITI Program Training Good Clinical Practice (GCP) module
To get started, please contact the IND/IDE Support Office at firstname.lastname@example.org to request any instructor-led training or consultation. Visit the CITI Program Training website in order to complete the Good Clinical Practice training module.