Basic Information

• Program type: Lecture
• Target audience: Academic and research staff, physicians, Principal Investigators (PIs), and other professionals involved in clinical research
• Duration: 2 hours or by arrangement
• 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

• The relationships between the sponsor, CRO, and research site and their impact on the negotiating position
• The main types of contracts and how to identify risky or unbalanced provisions in a Clinical Trial Agreement (CTA)
• How to assess liability, indemnification, payments, publications, intellectual property, data protection, and contract termination
• How to analyse budgets, fees, and payment terms and build arguments for improving them
• An understanding of CRO internal limits, approved alternative contractual wording (fallback language), and the escalation of requests
• How to use the priorities of the CRO and sponsor when preparing a negotiation strategy
• An orientation in ICH-GCP, TCPP, Fair Market Value, and ABAC
• Practical application of this knowledge to strengthen both the legal and financial position of the research site

Contacts