Protocol

Definition

A protocol is a plan for the construction and implementation of a research study or a secondary data analysis.Writing a protocol creates an instrument for planning details of how a research study will be conducted (or as many as can be anticipated by a team), ensuring quality control, and obtaining IRB approval for human-subjects research. When working with data, having a plan will allow the active data collection and analysis processes to run smoothly. Having a predefined protocol, particularly if it is published, guards against intentional or unintentional bias that can occur when outcomes to be measured and statistical tests are not decided at the outset. Publishing a protocol is also a way to make other researchers aware that this study is in progress so as to either not engage in similar research or to potentially contact the authors for preliminary results when citing. 

Examples

Similar Terms

Study plan
Tools

protocols.io is a platform for sharing experimental protocols and has protocols from a wide variety of research.

Further Resources

This paper walks through the preparation of a protocol for animal research:

Smith AJ, Clutton RE, Lilley E, Hansen KEA, Brattelid T. PREPARE: guidelines for planning animal research and testing. Lab Anim. 2018 Apr;52(2):135-141. https://doi.org/10.1177/0023677217724823 Epub 2017 Aug 3. PMID: 28771074; PMCID: PMC5862319.

This paper walks through the preparation of a protocol for clinical research:

Al-Jundi A, Sakka S. Protocol Writing in Clinical Research. J Clin Diagn Res. 2016 Nov;10(11):ZE10-ZE13. https://doi.org/10.7860/jcdr/2016/21426.8865 Epub 2016 Nov 1. Erratum in: J Clin Diagn Res. 2016 Dec;10 (12 ):ZZ03. PMID: 28050522; PMCID: PMC5198475.

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