Writing a Clinical Protocol: The Mechanics - Principles and Practice of Clinical Research - Chapter 26Clinical protocols are very important in clinical research. Use of innovative ideas will bring about improvements in the status of human health care. Well-designed research protocols help in bringing...
Clinical trial protocol documents play an important role in clinical research. However, clinical protocol writing remains a complex and relatively un-studied process. Protocols are often written by teams of people, yet little prior research has captured the problems or analyzed the collaboration support...
MEDICAL researchAUTHORSThe 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 wri...
Protocol amendments must be submitted in writing to the designated Institutional Review Board (IRB) and must be approved by the IRB before they can be implemented, except when necessary to eliminate immediate hazards to the participants or when the change(s) involves only logistical or administrative...
Authors' contributions:state how each author was involved in writing the protocol. Funding statement:preferably worded as follows. Either: 'This work was supported by [name of funder] grant number [xxx]' or 'This research received no specific grant from any...
Writing a clinical protocol initially appears to be a daunting task. By taking advantage of templates that are available electronically, however, you can draft a protocol relatively easily. Protocol templates for phase I and II clinical trials are available on a website of the Cancer Therapy Evalu...
A protocol amendment is a written description of a change to some aspect(s) of the study as described in the research protocol. 方案修订是对研究方案中所述研究某些方面的变更的书面说明。 Protocol amendments must be submitted in writing to the designated Institutional Review Board (IRB) and must ...
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including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing but also those wishing to perfect their existing writing skills, including full-time medical writers...
Benefit-finding writing has been associated with increases in positive affect and positive growth, and has demonstrated promising results in trials amongst other clinical populations. However, benefit-finding writing has not yet been examined in people with diabetes. Objective: The aim ...