Compliance with Human Research Protections in Sponsored Research

This document describes UW-Madison policies applicable to clinical trial agreements with research sponsors.

Adopted By: HRPP Advisory Committee
Adoption Date: March 1, 2012

Policy

  1. UW-Madison's standard clinical trials (CTA) agreement is the university's preferred document for CTA's. The standard CTA includes language addressing the following requirements:

    1. UW-Madison requires, when appropriate, that the sponsor state in the contract what provisions are being made by the sponsor for addressing medical care for research participants with a research-related injury. See, section 9 of the University's Standard Clinical Trial Agreement.

    2. When the sponsor conducts research site monitoring visits or monitoring activities remotely, UW-Madison requires the sponsor to state in the contract that the sponsor will promptly report to the UW-Madison findings that could affect the safety of participants or influence the conduct of the study. See, section 2.3 of the University's Standard Clinical Trial Agreement.

    3. When the sponsor has the responsibility to conduct data and safety monitoring per FDA regulations or as otherwise agreed to by the parties, UW-Madison requires the sponsor to include language in the contract that addresses the provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the UW-Madison. See, section 2.4 of the University's Standard Clinical Trial Agreement.

    4. UW-Madison requires the sponsor to state in the contract that the sponsor will notify the UW-Madison of study results when participant safety could be directly affected by study results after the study has ended, so that the researcher or UW-Madison may consider informing participants. See, section 3.20 of the University's Standard Clinical Trial Agreement.

    5. Before initiating research, UW-Madison obtains a written agreement with the sponsor regarding plans for disseminating findings from the research and the roles that the researcher and sponsor will play in the publication or disclosure of study results. See, section 8 of the University's Standard Clinical Trial Agreement.

  2. Use of a sponsor's CTA agreement template, instead of UW-Madison's standard agreement requires use of the UW-Madison's CTA Checklist to ensure that the human participants protection language required by Section I.A to E, above, appears in the CTA. The CTA Checklist refers to UW-Madison standard clinical trial agreement provisions for sample language when using sponsor clinical trial agreement templates.





Keywords:clinical trial agreement CTA research-related injury sponsor report findings data safety monitoring safety notify study results publication disclosure   Doc ID:29554
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-18 09:20 CDTUpdated:2017-04-19 10:57 CDT
Sites:VCRGE and Graduate School
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