Human Research Protection Program: Policy
Control of Test Articles Used in Research
Adopted By: All Campus IRB
Adoption Date: December 8, 2005
Revised: December 4, 2008
Purpose:
This document describes how the UW-Madison assures that handling of test articles
comply with FDA requirements.
Policy
I. As required by FDA regulations
governing test articles, the investigator has the responsibility to control the
test articles under investigation in a research study. The investigator must
assure that the test article is used only by those participating in the
research study and must maintain adequate records of the disposition of the
test article. If the investigation is terminated, the investigator must return
or destroy unused supplies of the test article pursuant to sponsor requirements
or applicable waste disposal regulations. If an investigational drug is
subject to the Controlled Substances Act, other precautions must be taken to
prevent theft or diversion of the drug. [21
CFR 312.61, 312.62, and 312.69 and 21
CFR 812.100, 812.110, and 812.140(a)]
A. Drugs and Biologics
1. All human subjects research involving drugs or biologics conducted by
UW-Madison personnel within the University of Wisconsin Hospital and Clinics
(UWHC) system must be coordinated through the UWHC’s Pharmaceutical
Research Center (PRC) and must comply with PRC’s procedures for the
control of study drugs used in research.
2. For research involving drugs and biologics conducted outside of the
UWHC system, the UW-Madison IRBs require the research site to have adequate
infrastructure in place to assure the proper control of investigational drugs
and biologics. It is the investigator’s responsibility to assure that
systems and procedures for control of the investigational drug or biologic
comply with FDA and other applicable regulations.
3. For research involving radioactive substances, the UW-Madison IRBs
require investigators to indicate in their protocol application that the
protocol has been reviewed and approved by the Radioactive Drug Research Committee/Pet
Research Committee (RDRC/PRC), which assures compliance with applicable
manufacture and control procedures as set forth in the UW-Madison Radiation
Safety Regulations.
B. Medical Devices
1. For research involving 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. It is the
investigator’s responsibility to assure that systems and procedures for
control of the investigational device comply with FDA and other applicable regulations.
2. For research involving medical devices conducted at external sites,
UW-Madison IRBs require the research site to have adequate infrastructure in
place to assure the proper control of investigational drugs and biologics. It
is the investigator’s responsibility to assure that systems and
procedures for control of the investigational device comply with FDA and other
applicable regulations.
C. All Veterans’ Administration (VA) research protocols involving
test articles, including those conducted by UW health sciences researchers with
paid appointments at the VA, those enrolling subjects (including use of
residual tissue and access to medical records) associated with the VA, and
those using VA facilities (e.g. space) must also comply with the VA
requirements for review of test article protocols and the storage and
procurement of investigational drugs and devices.
Procedure
II. Submission Requirements
A. In the application for initial review of
research involving test articles, the investigator is asked to describe to the
IRB the policies and procedures that will be used to control the test articles
used in the research protocol, including:
1. Who will be dispensing the drug or distributing device.
2. Where the drug or device will be housed.
3. Where the drug or device will be produced and information about quality
assurance.
4. Who will be keeping records and where the records will be stored.
B. For drug and biologic research conducted by
UW-Madison or UWHC personnel within the University of Wisconsin Hospital and
Clinics (UWHC) system, a reference by the investigator to the UWHC’s
Pharmaceutical Research Center (PRC) policies and procedures for control of
drugs is sufficient.
C. For device research conducted by UW-Madison or
UWHC personnel within the UWHC system, a reference by the investigator to the
UWHC’s policies and procedures for control of devices is sufficient.
D. If test article research is not conducted
within the UWHC system, the investigator must confirm to the IRB that the other
entity has written policies and procedures to control test articles and that
appropriate control mechanisms are in place. The IRB will rely on the other
entity to comply with and enforce its policies and procedures.
III. IRB Review of Test Article Controls
A. For drug and biologic research conducted by
UW-Madison personnel within the University of Wisconsin Hospital and Clinics
(UWHC) system, the IRB relies on the UWHC’s Pharmaceutical Research
Center (PRC) policies and procedures for control of drugs to assure that adequate
procedures are in place for the control of drugs used in a research protocol.
B. For device research conducted by UW-Madison
personnel within the UWHC system, the IRB relies on the UWHC’s policies
and procedures on control of devices to assure that adequate procedures are in
place for the control of devices used in a research protocol.
C. If test article research is conducted outside
of the UWHC system, the investigator must confirm to the IRB that the other
entity has written policies and procedures to control test articles and that
appropriate control mechanisms are in place. The IRB will rely on the other
entity to comply with and enforce its policies and procedures.
D. If a test article will be used in a
minimal risk non-therapeutic/non-clinical trial or represents an investigator-initiated protocol, the IRB will review test
article controls on a protocol-by-protocol basis using the information supplied
by the investigator in the application for initial review.
