Subject injury provisions often appear straightforward, yet some of the most significant legal, operational, and financial risks in a clinical trial agreement can be hidden within a few seemingly routine clauses. This session will explore the "trap doors" that sponsors, CROs, institutions, and sites frequently overlook, including ambiguities surrounding causation, standard of care, negligence, insurance coverage, informed consent language, and the interaction between subject injury and indemnification obligations. Using real-world negotiation examples, speakers will discuss how seemingly minor wording changes can dramatically shift responsibilities among parties and create unintended consequences when an injury claim arises. Attendees will leave with practical strategies for identifying hidden risks, avoiding common negotiation pitfalls, and drafting provisions that better align with the parties' actual expectations and responsibilities.
Merry Johnson - Senior Contract Analyst - WCG
Erik Martin - Shareholder - Polsinelli