chapter  8
10 Pages

Contracts, Clauses, and Closing the Deal

The clinical trial agreement (CTA) is one of several documents that govern the conduct of human subject research (Pfeiffer, 2014). Food and Drug Administration (FDA)-regulated medical product trials sponsored by pharmaceutical companies require a CTA. The CTA is a legal and binding contract that governs the conduct and responsibilities of the parties involved in the clinical research study (Webb, 2006). The CTA is the foundation on which the relationship between the sponsor, site, and the investigator is built (Pfeiffer, 2014). Often, CTAs are difficult to understand because of the legal verbiage. Understanding the CTA is critical for study staff as a simple human error may cause a breach of contract and result in serious financial and legal implications for a study site. This chapter will provide an overview of the regulations related to CTAs, key sections of the CTA, contract language, understanding the contract provisions, and negotiating contracts.