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Are your clinical trial agreements (CTA) protecting or exposing you? If you’re not 100% sure, you are vulnerable to unexpected expenses, unknown circumstances and damaging litigation.
The Site Guide to Crafting and Negotiating Clinical Trial Agreements has everything you need to create CTAs that safeguard your site.
Negotiating a CTA is a challenge in the best scenario. If you don’t know the legal power of the words and phrases you use, you can create a nightmare of misunderstandings, unintended commitments and accidental omissions.
In a CTA, certain words and phrases have incredible power to help you smooth and speed the process, giving you an agreement that serves the interests of all parties. Without this report, use them at your own peril, including terms like “independent contractor,” “affiliated hospital,” “confidential information,” “party to the agreement.” Their very precise meanings can negatively impact your clinical trial if used incorrectly in your CTAs.
This report, which features advice and insight from top site contract officers and attorneys, provides you with a crash course in how a CTA is crafted and how to negotiate an ironclad document that covers, rather than exposes you.
It begins with the dynamics of relationships among all parties to the CTA; walks you through the CTA’s scope, structure and content; and breaks it all down into key issues/clauses, clarifying both site and sponsor viewpoints on everything from conduct and compliance to human subject protections to registration and publication of trial results.
Report Takeaways:
- Who the real parties are to an agreement, who needs to be a party and why
- The purpose of the CTA’s preamble and what it should cover
- The difference between “employee” and “independent contractor” — and why it is a vital distinction
- The importance of debarment provisions and how to respond to contract qualifiers on debarment certification
- How to interpret important indemnification provisions and understand the differences between “indemnify” and “hold harmless”
If your CTAs don’t adequately cover all roles, responsibilities and liabilities, you’re vulnerable. Shield yourself with The Site Guide to Crafting and Negotiating Clinical Trial Agreements.
About the Contributors
A variety of experts contributed to this report, including:
Jody Ingebritsen-Howe |
Rikki-Quinn James-Renz |
Denise Imbriani |
Robert King |
Marlon Rajakaruna |
Padmini Menu |
Elizabeth Frey Miller |
Casi Morales |
Erik Martin |
Risa Burgess |
Cynthia Yoshimura |
Sherrie Bowen |
Who Will Benefit
- Contract/billing specialists
- Principal investigators
- Directors of research
- Site administrators/coordinators
- Regulatory/legal affairs staff
- Vendor management staff
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ISBN-13:
978-1-60430-195-3
Publication date:
May 2022
Page count:
65
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