Clinical Trial Protocol Writing
All clinical trials begin with a planning protocol and a detailed presentation of the trial’s all aspects. Clinical research protocols are of central importance in conducting clinical research. VeritasCRO has an organization which establishes procedures in basic subjects including feasibility and site selection, project design and protocol development. VeritasCRO has formed a project team dedicated to forming project designs in a logical manner, performing risk analysis and coming up with sustainable suggestions based on concrete evidence. The company executes and controls the whole process. The clinical trial protocol is an appropriate tool to highlight, accept and address ethical challenges specific to each study. Writing a detailed and complete protocol is an important step before starting a project. The protocol should be written simply and accurately, with all aspects clarified.
A research protocol is a document portraying the study schedule and plan for the research. This document must be designed meticulously in order to preserve participants’ safety and health. The protocol specifies the individuals involved in the study, timing of study procedures and the duration of the study. The company aims to write a research protocol according to national and international guidelines.
A priority in the composition of the protocol is being in accordance with the legal requirements of the country the research is performed in. All protocols are designed in accordance of Good Clinical Practice (GCP) guideline. Preliminary preparation should be done by creating a protocol template. Aspects to be included in the Study protocol are added to it and edited. It is significant to construct a summary before writing the whole document, in order to detect and filter out contradictions and avoid confusion. Including clearly determined goals streamlines the handling of the protocol as a whole by the authorities. The protocol should contain flexible expressions in order to prevent deviations. A well-written protocol must also include a timeline for allowing data collection and development/improvement.
References:
1.Al-Jundi A. et al. Protocol Writing in Clinical Research, Journal of Clinical and Diagnostic Research. 2016 Nov, Vol-10(11): ZE10-ZE13
2.O’Brien K et al. How to write a protocol. J Orthod.;29:58–61. [PubMed] [Google Scholar], 2002
3.Camelini M. et al. How to Write a Research Protocol: Tips and Tricks, J Cardiovasc Echogr. 28(3): 151–153. doi: 10.4103/jcecho.jcecho_41_18, Jul-Sep 2018
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