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Institutional Risk Assessment and the Review of Subject Injury Language for Clinical Trials


Reviewing and negotiating subject injury language in the clinical trial agreement (CTA) and ensuring its congruency in the informed consent form (ICF) can present challenges for the research institution such as determining the appropriate language for the situation and the negotiation of that language with the Sponsor; assessing the institutional risk of acceptance of such language; as well as compliance with Institutional policies and guidelines, accreditation standards (i.e., Association for the Accreditation of Human Research Protection Programs (AAHRPP) and the Medicare Secondary Payer provisions. This webinar will focus on the presentation of a workflow process implemented at Virginia Commonwealth University (VCU) utilizing standard subject injury language templates in conjunction with the OnCore clinical trial management system that may be useful to your organization in streamlining the approval and tracking process in your review of subject injury language prior to Institutional Review Board submission. The task lists developed in OnCore document the subject injury language review process and serves to ensure not only that the CTA and ICF language are congruent but that it also occurs in a timely manner for submission to the Institutional Review Board. This process establishes a level of consistent communication between Schools, study teams, OnCore management and the Division of Sponsored Programs highlighting the importance of collaboration and underscores the need for a clear understanding of how subject injury language impacts Institutional risk, study participants and compliance with applicable law. Congruent review of the subject injury language is not only key to ensuring compliance with AAHRPP standards and Medicare Secondary Payor laws but also serves to provide clearer information to potential study participants.

Learning Objectives:

  1. Analyze the impact of subject injury language review on Institution's risk assessment
  2. Learn to ensure compliance with Institutional policies and federal regulation
  3. Establish a system for tracking subject injury language review
Knowledge Level: Intermediate

Individual Registration:
Group Registration:
Member Price: $45
Member/Non-Member Price: $250
Chapter/Non-Member Price: $90


  • Melanie Wiggins, Director, Division of Sponsored Programs, Industry and Clinical Trials, Office of the Vice President for Research and Innovation, Virginia Commonwealth University

    Melanie Wiggins is the Director of Sponsored Programs for Industry and Clinical Trials in the Office of the Vice President for Research and Innovation at Virginia Commonwealth University (VCU). Melanie has extensive work experience in research administration both at the departmental level and the central office level. Melanie has served at VCU for 26 years, with 10 years as a departmental administrator for the Division of Cardiology and 16 years in Sponsored Programs providing oversight of for-profit industry collaborations. Melanie has experience in clinical trial administration, contract negotiation and in providing training to research administrators within Virginia Commonwealth University and at international and Chapter SRAI meetings. Melanie's office reviews and negotiates clinical trial agreements and reviews/negotiates subject injury language contained in the informed consent forms for industry sponsored clinical trials to determine if the language is appropriate for the type of study, if it is consistent with the clinical trial agreement and if it is compliant with institutional policies, applicable laws and regulatory guidelines. Working with the School of Medicine, Massey Cancer Center and the OnCore team at VCU, Melanie implemented a subject injury review workflow which utilizes the internal sponsored programs electronic database and the OnCore clinical trial management system to track and record the review and approval of subject injury language for internal record keeping purposes and to facilitate the submission to the appropriate Institutional Review Board.

November 17, 2020
Tue 2:00 PM EST

Duration 1H 0M

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