What is this service?
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required by an active IND or IDE, which might include:
· Annual reports
· Safety and Adverse Event reports
· Request for Withdrawal or Inactivation
· All FDA forms and correspondence.
Who can use this service?
Any U-M investigator who is the sponsor-investigator for an IND/IDE can use this service.
When should I contact MICHR about this service?
You should contact MIAP as soon as an IND or IDE is granted or required.
How much does this service cost?
MIAP charges a flat fee of $75 per hour. Please contact MIAP for assistance with budgetary planning.