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Site Forms and Institution Policies

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Date and Time: July 21, 2020 @ 12:00 PM ET


Contact Hours: One contact hour will be issued.
Contact Hours are not available for archived webinars.


Presenter
Jessica Silver, Esquire 

Associate Director, Global Site Agreements, North America and Translational Pharmacology (ESD) Agreements Management, Global Clinical Trials Organization, Merck & Co.

Description

Sponsors are increasingly being asked to sign site forms in order to get access to electronic medical records (EMR) systems or to access an institution’s facilities. Sponsors also may be asked to follow and agree to institution’s policies either through language in the clinical trial research agreements or through language in the site forms. This presentation reviews the complexities of site forms and Institutional policy language from the perspective of a sponsor and sheds light on the need for sponsors and institutions to work together to reach agreement so we can effectively run clinical trials.

Learning Objectives

    1. Understand language which may be problematic to sponsors in site forms and institution policies.
    2. Learn negotiation tactics for negotiating language in site forms
    3. Find alternative paths to problematic language in site forms and institution policies through clinical trial research agreement language


Jessica (Jess) Silver is Associate Director of Global Agreements within Merck & Co.’s Global Clinical Trial Operations (GCTO) organization. Specifically, Jess is the lead for North America (USA and Canada) Clinical Trial Research Agreements, both in late and early stage development. In addition, Jess is the subject matter expert (SME) on institution policy/site form reviews within Global Agreements, GCTO. Jess focuses on reducing cycle times by ensuring there are limited delays in contract execution due to legal language hold ups. 

Jess joined Merck & Co. in August 2016 as the Associate Director of Global Agreements, with a focus on process improvement in the Center for Observational and Real-World Evidence (CORE) space. Prior to that, Jess worked for RPS and PRA Health Sciences as a fully embedded contractor within Merck & Co. for 4+ years, with a focus on US contract, budget and informed consent negotiations. Jess received a B.A. in 2008 from Tulane University and a J.D. in 2011 from Pace University School of Law.

Society for Clinical Research Sites, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.


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  2. The post webinar survey immediately following this webinar must be completed in its entirety.
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Planners, presenters, faculty, authors, and content reviewers do not have any relevant financial relationships with any commercial interest.

This webinar does not imply any endorsement of products or services by the Society for Clinical Research Sites or ANCC.

The materials and recording of this webinar will be available for one year as an archive, but will not award any contact hours.


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