Basic Information

• Program type: Lecture
• Target audience: Academic and research staff, physicians, Principal Investigators (PIs), and other professionals involved in clinical research
• Duration: 2–3 teaching hours, as needed
• Capacity: Unlimited
• Language: Czech
• Date: By arrangement

Detailed Description

The lecture focuses on the contractual and financial aspects of clinical trials from the perspective of an academic or hospital institution. Participants will become familiar with the main types of contracts and documents, including CDA, Clinical Trial Agreement (CTA), Master Agreement, Data Processing Agreement (DPA), Budget Agreement, ancillary agreements, and amendments.

Particular attention will be paid to key CTA provisions, especially liability and indemnification, payment terms, publications, intellectual property, data protection, and contract termination. A dedicated section will demonstrate how to negotiate effectively with CROs and Sponsors, how internal limits, fallback positions, and escalation procedures work, and will offer a “view from the other side of the table” based on practical contract management experience with leading global CROs.

TCPP, Fair Market Value, ABAC, start-up and administrative fees, and budget escalation will also be discussed. Practical examples will demonstrate how to strengthen the legal and financial position of the research site. The session will include discussion and an opportunity for questions.

What Participants Will Learn

• An overview of the main types of contracts and documents used in clinical trials
• An understanding of the key provisions of the Clinical Trial Agreement (CTA)
• Practical skills for negotiating with CROs and Sponsors
• An understanding of internal limits, fallback positions, and escalation procedures
• An understanding of the financial aspects of clinical trials, including TCPP, Fair Market Value, ABAC, start-up, and administrative fees
• The ability to strengthen the legal and financial position of an academic or hospital institution

Contacts