Michigan IND/IDE Investigator Assistance Program
Empowering Researchers & Clinical Research
Helping researchers navigate requirements for investigational drugs, devices and biologics.
About the Program
The Michigan IND/IDE Investigator Assistance Program (MIAP) provides consultation on research involving investigational agents (drugs, devices, and biologics) that includes:
- Determination of FDA regulatory pathway and need for an IND (Investigational New Drug) or exemption, IDE (Investigational Device Exemption), orphan disease designation, or humanitarian use device (HUD).
- Protocol and informed consent review and assistance.
- Assistance with FDA meeting requests, preparation, and support.
- Expertise and guidance on navigating investigational agent regulation and compliance.
Contact Us
For questions, please contact the MIAP team:
Email: [email protected]
Consultations & Services
Initial consultations, which include assessing if you will need an IND or IDE for your study, advice on filling out sections 15 and 16 of your eResearch application, completing an IND or IDE decision worksheet, and determining if a submission to the FDA is needed, are free.
IND/IDE FDA Pre-submission Meetings offer support and expertise in preparing and submitting investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests to the FDA. The cost varies with the complexity of the submission.
The following services are available and are fee-based at $90/hour:
- IND/IDE Application Preparation & Submission Support provides expertise in preparing and submitting Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the FDA, which may be required for the use of investigational drugs and devices in clinical research.
- IND/IDE Lifecycle Maintenance The IND/IDE Investigator Assistance Program provides support for all submissions that may be required under an active IND or IDE, which might include: annual reports, amendments, safety and adverse event reports, requests for withdrawal or inactivation, all FDA forms and correspondence.
Resources
- IND/IDE Decision Worksheets - Worksheets to facilitate the development, review and oversight of new drugs, biologics and devices that require regulatory approval prior to dissemination.
- IND/IDE Sponsor-Investigator Training is training required as part of your sponsor-investigator responsibilities when you hold an IND or IDE. More information on sponsor-investigator responsibilities is available in the University of Michigan Human Research Protection Program Operations Manual.
- Abbreviated IDE Requirements describes the FDA regulations specific to conducting a clinical trial with a non-significant risk (NSR) device.
Study Monitoring for IND/IDE Investigator-Initiated Clinical Trials
Independent monitoring is available for IND/IDE investigator-initiated clinical trials using MIAP services. The Food and Drug Administration (FDA) requires the sponsor, including sponsor-investigators, who hold an IND/IDE to ensure proper clinical trial monitoring. Our monitors will follow standard operating procedures and detailed monitoring plans, written in conjunction with the investigator, to provide a tailored approach for monitoring needs. This offering is fee-based at $100/hour.
Resources
- Study Management Templates and Guidances - adaptable and downloadable templates that can be used to organize and maintain research study documentation, as you would include in a regulatory binder.
