ABSTRACT
This chapter reviews the principles of contract law and then focuses on a typical clinical research contract. It addresses recognising the wide use of English law as the applicable law in the contract. The chapter considers negotiation statements, promises, implied terms and exclusion clauses. Despite obvious local jurisdictional and practical differences and the absence of any significant degree of EU contract law harmonisation, it is possible to offer general guidance and insight on the current provisions commonly seen in contract research contracts. The process of negotiating the written contract is a vital opportunity to improve the prospects for a successful implementation and continuing good relationship by clarifying prior understandings and negotiations. In addition to analysing contract clinical research needs, future changes to those requirements must be considered and provided for in the contract. Master contract clinical research contracts are, by their nature, long-term, requiring a significant commitment from the sponsor.
