CITI Program Webinar Demo - Managing Risk by Contract

Protracted clinical trial agreement (CTA) negotiations often delay the start of a study. Understanding each party’s motivation and expectations facilitates quicker issue resolution, thereby expediting the CTA to signature. This webinar discusses CTAs from the perspective of the study sponsor, providing tips along the way for streamlined negotiations. It addresses access and ownership of study data and specimens, the impact of digital health technologies and decentralized clinical trials, cybersecurity concerns, subject injury and indemnification provisions, and insurance obligations. The webinar also provides sites and investigators with an understanding of sponsor concerns with CTAs. It concludes by offering effective strategies for the sponsor and research site to follow. Learning Objectives - Describe sponsor goals and concerns regarding study data, source records, and specimens in the clinical trial agreement (CTA). - Explain how digital health technologies (DHTs), decentralized clinical trials (DCTs), and cybersecurity concerns impact CTA negotiations. - Describe sponsor goals and concerns regarding risk allocation, including subject injury, indemnification, and insurance in the CTA. - Identify ways to expedite CTA negotiations. Presented by: Katherine Leibowitz, JD - Leibowitz Law For access to the full webinar please visit: https://about.citiprogram.org/course/managing-risk-by-contract/