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Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers

Structuring Indemnification, Subject Injury, IP Rights, Data Rights, and Other Key Provisions

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Wednesday, April 26, 2023

Recorded event now available

or call 1-800-926-7926

This CLE course will review critical provisions in clinical trial agreements (CTAs), discuss variations in study site structure and potential impact on CTA signatories, outline best practices for structuring effective provisions and contracts, and guide healthcare counsel on handling the potential challenges in CTA negotiations.


CTAs are critical to allocate risk and protect parties' rights, including to study data and intellectual property. Negotiating issues such as indemnification and subject injury can pose hurdles that may delay or even kill negotiations.

Significant concerns include confidentiality and HIPAA. Counsel must thus include clear and specific provisions in the CTA that address each party's needs and expectations. These provisions can play into data rights, monitoring, indemnification, and limitations of liability.

Counsel to healthcare providers and pharmaceutical and medical device companies must anticipate issues that can impede negotiations. Careful structuring of the CTA is crucial to ensure risk allocation and protection of rights.

Listen as our panel of healthcare attorneys examines the potential obstacles in CTA negotiations, key provisions to include in CTAs, and the critical issues surrounding those provisions. The panel will outline best practices for effectively crafting those provisions.



  1. Challenges in negotiating a CTA
    1. Proper signatories
    2. Regulatory compliance
    3. Indemnification
    4. Subject injury
    5. Insurance
    6. IP ownership
  2. Key provisions to include in a CTA
    1. Compensation
    2. Data rights
    3. IP rights
    4. Publication
    5. Confidentiality
    6. Record retention
    7. Monitoring, audit, and FDA inspection
    8. Indemnification
    9. Subject injury
    10. Limitation of liability
    11. Insurance
    12. Use of name
    13. Termination
  3. Best practices for effective negotiation


The panel will review these and other key issues:

  • What are the significant stumbling blocks that can hinder the parties in negotiating a CTA?
  • Why does it matter if you do not figure out the proper contracting parties?
  • What scope of indemnification is appropriate? What is a commercialization indemnity? What does it mean to indemnify for use of study data and results?
  • How do we draft a subject injury provision that protects both parties? Should insurance be billed first? What if the provider is not the research institution?
  • What human subject protection language is mandated by AAHRPP?
  • What CTA provisions ensure that the trial sponsor owns the intellectual property created as a result of the clinical trial? What scope of assignment would be acceptable to all parties?
  • What language do you need to review to make sure the informed consent form is consistent with the CTA subject injury provision and the CTA budget?
  • Do sponsors need the right to copy and remove PHI from the study site?


Coulter, Amanda
Amanda K. Coulter

Of Counsel
Coppersmith Brockelman

Ms. Coulter advises clients in the healthcare industry on clinical research matters. She has extensive experience...  |  Read More

Leibowitz, Katherine
Katherine Leibowitz

Co-Founder, Head of Legal Services
Leibowitz Law

Ms. Leibowitz’s technology practice includes life sciences transactional work for companies seeking to develop,...  |  Read More

Kate Duffy Mazan
Kate Duffy Mazan

Clinical Technology Transfer Group

For the past 20 years Ms. Mazan has practiced exclusively in the area of food and drug law with an emphasis on the...  |  Read More

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