Volume 23, Issue 2 - Regulatory Writing Basics
The clinical study protocol and medical writing: A good fit?
Author: Walther Seiler
Abstract
The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers are encouraged to participate in the development of the CSP template of their organisation.
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References
- Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7.
- Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.
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