Online Course: Investigational New Drug and Investigational Device Exemption Training Course

This self-guided course is designed to introduce you to regulatory responsibilities of sponsors and investigators of drug and device studies.

Audience

While the primary audience for this course is U-M clinical researchers and study teams, anyone with a U-M Level 1 account is more than welcome to take it.

This course will:

• Walk through the regulatory responsibilities of sponsors and investigators

• Highlight the ways that MIAP can help with your IND or IDE application

• Provide important contact information and resources

How to Access

This course is free and can be found by searching on the MyLinc training platform here. Visit step-by-step instructions on accessing the course here.

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Related Links & Resources

• Electronic Code of Federal Regulations

  • Title 21 Part 50 - Protection of Human Subjects

  • Title 21 Part 54 - Financial Disclosure by Clinical Investigators

  • Title 21 Part 312 - Investigational New Drug Application

  • Title 21 Part 314 - Applications for FDA Approval to Market a New Drug

  • Title 21 Part 601 - Licensing

  • Title 21 Part 812 - Investigational Device Exemptions

  • Title 21 Part 801 - Labeling

  • Title 21 Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

  • Title 21 Part 814 - Premarket Approval of Medical Devices

  • Title 21 Part 820 - Quality System Regulation

  • Title 42 Part 11 - Clinical Trials Registration and Results Information Submission

• FDA Guidance Document - Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

• Good Clinical Practice (GCP) Resources at U-M

  • Study Management Templates

  • Human Research Protection Program (HRPP) Policy

  • CITI Program Course

  • IRBMED Instructional for ICH-GCP Clinical Trials

  • Best Practices in Social and Behavioral Research Course

  • FDA Guidance Document - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

• Human Research Protection Program (HRPP) Operations Manual

• FDA Submission Timetables

• IND Decision Worksheet

• IND Decision Worksheet Reference Document

• IDE Decision Worksheet

• Institutional Review Boards (IRBMED)

• Office of Regulatory Affairs

• Office of Research Compliance Review

• Office of the Vice President and General Council

• Guidance Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies