Clinical Trial Agreements: Negotiation and Management.

      Аннотация: Collaboration between industry and investigators is essential in the ongoing development and marketing of medical products. With the majority of funding for clinical trials coming from industry it is critical that the investigator is able to appropriately manage the clinical trial agreement which governs the conduct of the study. Very little literature exists defining the investigator's role or involvement in the clinical trial agreement process. This book provides the first systematic examination of current practices by U.S. investigators in the management of the Clinical Trial Agreement. Topics examined include the level of investigator engagement in the contract process, knowledge and understanding, factors affecting involvement, and issues surrounding the agreement. This book is especially useful to research professionals who conduct industry-sponsored research and can assist in negotiating a fair and balanced contact for your clinical trials.

Ключевые слова: Negotiation, Regulations, Contracts, clinical trials, Investigator, contract terms, contract issues