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Clinical trial protocols: study protocol 

Clinical trial protocols: study protocol
Chapter:
Clinical trial protocols: study protocol
DOI:
10.1093/med/9780199608478.003.0015
Page of

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date: 20 January 2021

This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well written. The chapter describes the procedures before embarking on writing a protocol, who should be involved and describes all the main elements to be included. The ICH E6 guidelines give a complete list of the content of a protocol so this chapter centres on the main decisions/considerations. The main considerations are outlined in a skeleton protocol which includes for example objectives and end points, subject population, study design, study methodology, assessments and timings and statistical considerations. Once these main decisions have been made the first full draft protocol can be written by elaborating every detail and adding the administrative sections as set out in the company/institution SOPs and the ICH GCP guidelines. The process of protocol approval is described along with the requirements for protocol amendments. The additional requirements to be considered in writing protocols for healthcare studies is set out especially the ethical requirements that have to be addressed.

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