FDA Regulated Research Policies and Guidance
The following policies and guidance documents are intended for researchers working with drugs, devices, and biologics regulated by the US Food and Drug Administration (FDA). The policies and guidance are meant to assist researchers with ensuring compliance with both FDA regulations and institutional requirements.
Health Sciences IRBs Policies
The UW-Madison Health Sciences IRBs review all human subject research protocols in accordance with applicable federal regulations, including FDA regulations. The following documents represent the HS IRBs policies and procedures for the review of FDA regulated research submissions.
Policies:
- Review of FDA Regulated Research Policy
- This document describes the policy the Health Sciences IRBs follow for conducting reviews of applications that fall under FDA regulations.
- Control of Test Articles Used in Research Policy
- This document describes the policy researchers must follow regarding the control of test articles that fall under FDA regulations and how the Health Sciences IRBs assess the control of test articles used in research.
- Emergency Use of Test Articles and of Humanitarian Use Devices Policy
- This document describes the policy the Health Sciences IRB follows for the emergency use of test articles and the emergency use of Humanitarian Use Devices (HUDs).
- Humanitarian Use Device Policy
- This document describes the policies the Health Sciences IRB follows for conducting reviews of applications involving Humanitarian Use Devices (HUDs).
- Guidance on Requirements by the FDA for the Investigator as a Sponsor
- Guidance on FDA Regulation of Medical Mobile Apps
- Investigational Software Guidance
- Guidance and Templates for Emergency or One-time Use Requests
- Reporting Requirements for Studies Involving Investigational Devices
- Reporting Requirements for Studies Involving Other Investigational Agents, Including Investigational Drugs
The FDA Regulated Research Oversight Program is charged with drafting policies and establishing guidance for UW-Madison researchers conducting FDA regulated research. In addition, the Oversight Program registers and tracks investigator held INDs and IDEs, performs routine audits of all FDA regulated research studies to verify investigator compliance with FDA requirements, and ensures timely and appropriate communications with the FDA. The following policies apply to UW investigators who conduct FDA regulated research and holders of an IND or IDE.
To learn more, ask general questions, and/or inquire about available resources and services contact:
Tracy Ohrt, Administrative Director Tim Sparks, Scientific Director
Phone: (608) 262-7505 Phone: (608) 265-3158
Policies:
The following policies apply to all FDA regulated research studies:
- FDA Inspection and External Audits Policy
- This policy describes the requirements for research staff to contact the Oversight Program upon notification of an inspection by the FDA or of an audit by another external agency (e.g., National Institute of Health (NIH)).
The following policies apply to all UW investigator held INDs and IDEs:
- IND/IDE Holder Routine Compliance Review Policy
- This policy describes the Oversight Program's performance of routine compliance reviews of clinical trials conducted under UW-Madison Investigator held INDs or IDEs to ensure compliance with applicable laws, regulations, policies and guidelines.
- IND/IDE Registration Policy
- This policy describes the Oversight Program's maintenance of a registry of all UW-Madison investigator-held INDs/IDEs to ensure institutional compliance with the FDA requirements and assist investigators in fulfilling their FDA obligations.
- IND/IDE Holder Training Policy
- This policy describes the training requirements that UW-Madison Investigators who hold an IND and/or IDE must complete to ensure they are aware of their obligations to conduct research in compliance with FDA requirements.
- IND/IDE Consultation Service
- The IND/IDE Consultation Service is a dedicated IND and IDE support service for investigators to assist in understanding and navigating IND/IDE requirements.
- IND/IDE Resource Library
- The IND/IDE Resource Library provides materials including IND-related Templates, IDE-related Templates, FDA Resources for Drugs, and FDA Resources for Devices.
- Clinical Research Toolkit
- The Clinical Research Toolkit provides templates and tools to assist investigators in the conduct of clinical research.