Research Support Units

MICHR Regulatory Support

MICHR Regulatory Services

MICHR IND / IDE Investigator Assistance Program (MIAP)

The MICHR IND¹ / IDE² Investigator Assistance Program (MIAP) has been established to provide comprehensive regulatory support, guidance and education services to faculty investigators involved in US FDA³ regulated clinical research at the University of Michigan.

The MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the University of Michigan and the United States Food and Drug Administration (FDA).

The MIAP program 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 an investigational medical device subject to Investigational Device Exemption (IDE) regulations, per 21 CFR Part 812. Regulatory assistance is available for:

IND & IDE Regulatory Education Services
- Investigator Responsibilities per FDA Regulations
  - IND Outreach - Responsibilities of IND Sponsor-Investigators
    (1.3M PDF)
- IND (21 CFR Part 312) Regulation Overview Training
- IDE (21 CFR Part 812) Regulation Overview Training
- Good Clinical Practice (GCP)Training & Coaching
- FDA Quality System Regulations & Good Manufacturing Practice Training
- Adverse Event Reporting Requirements for Investigator-Initiated Research
- IND Application Process Overview
- IDE Application Process Overview
- IND & IDE Annual FDA Reporting Requirements Training
Sponsor-Investigator IND & IDE Assistance
MICHR 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 & IDE Applicability Assessments
    - IND Requirement or Exemption Determinations
    - IDE Requirement or Exemption Determinations
    - Exemption Rationale Development
  - IND & IDE Submission Assistance
    - Protocol Development Assistance
    - Literature Search Assistance
    - IND & IDE Submission Preparation
    - IND & IDE FDA Application Assistance
    - FDA Contact & Correspondence Assistance
- On-going Study Assistance
  - Clinical Trial Monitoring
  - Safety & FDA Vigilance Reporting
  - IND & IDE FDA Annual Report Preparation and Submission
  - DSMB Communications Assistance
  - IND & IDE Protocol Amendment Preparation Assistance
  - IND Amendments and Life Cycle Maintenance Assistance
  - IDE Supplements and Life Cycle Maintenance Assistance
- Post-study Assistance
  - IND & IDE Clinical Study Close-out Support
  - IND & IDE Submission Close-out Support
  - Publications Support
Additional MICHR Regulatory Support Services
- IRB Regulatory Support
  - IRB Related Regulatory Support Including Coordination of Multi-Site IRB Submissions
  - Informed Consent Preparation Assistance
  - Protocol Preparation Assistance
  - Case Report Forms (CRF) Preparation Assistance
  - Clinical Data Integrity Assurance Support
  - Regulatory Guidance, Updates And Education Services
  - Assistance Determining The Need for an FDA Approved IND or IDE Application
  - Regulatory Assistance Regarding FDA, NIH, HHS & Other Federal & State Agencies

  ¹ Investigational New Drug (21 CFR Part 312)
  ² Investigational Device Exemption (21 CFR Part 812)
  ³ United States Food and Drug Administration

Contact:

For questions about regulatory support for clinical research please contact:

Kevin Weatherwax
Manager, Project Management and Monitoring (PMM)
kweath@umich.edu
(734) 998-6275

Kay Fuller, RAC
Program Manager, MICHR IND / IDE Assistance Program (MIAP)
kfull@umich.edu
(734) 998-6059

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