The IND/IDE Assistance Program has been established to assist investigators holding an IND or IDE at all stages of an investigation. Specifically, the IND/IDE assistance program will:
Assist in the determination if there is a requirement for the submission of an investigator-sponsored IND or IDE.
Provide education to investigators regarding the regulatory responsibilities as the sponsors of INDs or IDEs.
Provide guidance in the preparation and submission of sponsor-investigator IND or IDE requirements.
Provide regulatory assistance during FDA inspections of sponsor-investigator clinical trials.
The program may be accessed via email at INDhelp@columbia.edu.
Please find the IND and IDE Decision Worksheets below.