Product Details
Revolutionize your clinical trial agreement (CTA) negotiations when you know what the other side is thinking. You’ll know when to push, when to hold off and when to walk away.
Perspectives on Clinical Trial Agreements: What Sites, Sponsors and Stakeholders Need not only tells you what points you must cover in your negotiations, it breaks them down into key issues and clauses, showing you how to look at them from both sides so you can craft agreements that are more mutually beneficial.
When you understand exactly what the other side wants, it improves your bargaining position.
Perspectives on Clinical Trial Agreements shares this dual view so you can best negotiate compensation; conduct and compliance; confidentiality; data monitoring; human subject protections; indemnification, liability, insurance and subject injury; informed consent; IRB approval; protected health information; ownership; registration and publication of trial results; and much more.
Based on presentations by multiple subject matter experts at MAGI’s Clinical Research vConference — Spring 2021, Perspectives on Clinical Trial Agreements reveals how to negotiate the most advantageous contracts possible:
- The relationships among the various parties to a CTA
- The meaning of key terms
- The structure and scope of a CTA
- How to craft individual sections of a CTA, including:
- Records storage and maintenance
- Indemnification and liability
- Publishing study results
- Ownership of data and intellectual property
- Debarment and exclusion
About the Contributors
Denise Imbriani, JD LLM |
Marlon Rajakaruna, BA LLB MBA CRCP |
Elizabeth Frey Miller, JD |
Erik Martin, JD LLM |
Cynthia Yoshimura, JD |
Rikki-Quinn James-Renz, MBA SSGB CRCP |
Robert King, JD |
Padmini Menu, JD MBA MS |
Casi Morales, JD |
Risa Burgess, Paralegal |
Sherrie Bowen, JD CRCP |
Who Will Benefit
- Contract/billing specialists
- Principal investigators
- Directors of research
- Site administrators/coordinators
- Regulatory/legal affairs staff
- Vendor management staff
Add to Cart
Contributors:
Denise Imbriani, JD LLM; Marlon Rajakaruna, BA LLB MBA CRCP; Elizabeth Frey Miller, JD; Erik Martin, JD LLM; Cynthia Yoshimura, JD; Rikki-Quinn James-Renz, MBA SSGB CRCP; Robert King, JD; Padmini Menu, JD MBA MS; Casi Morales, JD; Risa Burgess and Sherrie Bowen, JD CRCP
ISBN-13:
978-1-60430-169-4
Publication date:
Sept. 2021
Page count:
26
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