Summary: This document describes the policy researchers must follow regarding the control of test articles that fall under US Food and Drug Administration (FDA) regulations and how the Health Sciences IRBs assess the control of test articles used in research.
Adopted by: HS IRBs Policy Committee
Adoption date: October 5, 2015
1. Principal investigators (PIs) have the responsibility to control the test articles under investigation in their research studies in compliance with applicable institutional and FDA regulations.
1.1. Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the FD&C Act.
2. PIs must assure that the test article is used only by those participating in the research study; stored, secured, and labeled so that they are identified as for research and/or investigational use only; and adequate records of test article disposition maintained.
3. If a study involving a test article is terminated, the PI (or designee) must return or destroy unused supplies of the test article pursuant to sponsor requirements or applicable waste disposal regulations.
4. If test article is subject to the Controlled Substances Act, other precautions must be taken to prevent theft or diversion of the drug.
5. Test Articles - Drugs/Biologics
5.1. All human subjects research involving drugs or biologics conducted by UW-Madison personnel within the UW Health system must be coordinated through the UW Hospital and Clinics’ Pharmaceutical Research Center (PRC) and must comply with PRC’s procedures for the control of study drugs used in research.
5.2. All human subjects research involving drugs or biologics conducted by Madison Veterans Administration (VA) Hospital personnel at the Madison VA must be coordinated through the Madison VA’s Research Pharmacy and must comply with Madison VA’s procedures for the control of study drugs or biologics used in research.
5.3. For research involving drugs and biologics conducted outside of the UW Health system or Madison VA, the UW-Madison Health Sciences IRBs require the research site to have adequate infrastructure in place to assure the proper control of investigational drugs and biologics.
5.3.1. It is the PI’s responsibility to assure that systems and procedures for control of the investigational drug or biologic comply with FDA and other applicable regulations.
5.4. For research involving the introduction of radioactive substances into human subjects, the UW-Madison Health Sciences IRBs require study teams undergo review by the Radioactive Drug Research Committee (RDRC).
5.4.1. The RDRC assures compliance with applicable manufacture and control procedures as set forth in the UW-Madison Radiation Safety Regulations.
6. Test Article - Investigational Medical Devices
6.1. For research involving investigational medical devices, procedures for controlling access to and use and disposal of devices and assuring maintenance of required records are established at the departmental level.
6.1.1. All Madison VA research studies involving investigational devices, must also comply with the VA requirements for control and procurement of investigational devices.
6.1.2. It is the PI’s responsibility to assure that systems and procedures for control of the investigational device comply with FDA and other applicable regulations, including ensuring personnel who may use the device are appropriately trained and qualified to use the device safely, and documenting who is designated to use the device, where the device will be shipped to and stored, the procedures for the release of the device (e.g., with a written physician’s order), and how inventory will be maintained.
6.1.3. For research involving medical devices conducted at sites external to UW Health or the Madison VA, UW-Madison Health Sciences IRBs require the research site to have adequate infrastructure in place to assure the proper control of investigational devices.
6.1.4. It is the investigator’s responsibility at that site to assure that systems and procedures for control of the investigational device comply with FDA and other applicable regulations.
- This policy applies to how FDA regulations are applied to the control of test articles in human subjects research.
Applicable HRPP Policy
Attachments and Other References
- Issues in Human Subjects Research When State Law May Apply
- UW Health Policy 4.11 Investigational and Study Drug Control (Requires access to UConnect, UW Health’s intranet)