Research Management Services

MICHR IND/IDE Investigator Assistance Program (MIAP)

Overview

The MICHR IND / IDE Investigator Assistance Program (MIAP) was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US Food and Drug Administration (FDA) regulated clinical research at the University of Michigan.

MIAP's primary focus is regulatory assistance to sponsor-investigators of a new drug, biologic or medical devices. Our efforts help ensure clinical research excellence and regulatory compliance as set forth by the University of Michigan Health System and the FDA. We are certified regulatory professionals with varied biomedical backgrounds in both academia and industry. Combined, our experiences include over 75 years in clinical and preclinical research and over 45 years in regulatory affairs. Let us leverage that knowledge to help you attain your goals.

MIAP offers regulatory assistance to clinical investigators planning to utilize either a drug or biological product classified by the FDA as an Investigational New Drug (IND) per 21 CFR Part 312 or a medical device subject to Investigational Device Exemption (IDE) regulations per 21 CFR Part 812. Regulatory assistance includes:

IND and IDE Regulatory Education Services
- Investigator responsibilities per FDA regulations
  - Responsibilities of IND Sponsor-Investigators (.PDF)
- IND (21 CFR Part 312) regulation overview training
- IDE (21 CFR Part 812) regulation overview training
- Good Clinical Practice (GCP) training and coaching
- FDA quality system regulations and Good Manufacturing Practice training
- Adverse Event Reporting requirements for investigator-initiated research
- IND application process overview
- IDE application process overview
- IND and IDE annual FDA reporting requirements training

Sponsor-Investigator IND and IDE Assistance

MIAP provides comprehensive regulatory guidance and assistance to clinical investigators seeking to conduct clinical investigations that require US FDA approval prior to implementation. Regulatory assistance includes:
- Pre-study preparation assistance
  - IND and IDE applicability assessments
    - IND requirement or exemption determinations
      - IND Decision Worksheet (.PDF)
    - IDE requirement or exemption determinations
      - IDE Decision Worksheet (.PDF)
    - Exemption rationale development
  - IND and IDE submission assistance
    - Protocol development assistance
    - Literature search assistance
    - IND and IDE submission preparation
    - IND and IDE FDA application assistance
    - FDA contact and correspondence assistance
- On-going study assistance
  - Safety and FDA vigilance reporting
  - IND and IDE FDA annual report preparation and submission
  - DSMB communications assistance
  - IND and IDE protocol amendment preparation assistance
  - IND Amendments and Life Cycle Maintenance assistance
  - IDE Supplements and Life Cycle Maintenance assistance
- Post-study assistance
  - IND and IDE clinical study close-out support
  - IND and IDE submission close-out support
  - Publications support