Tips from an expert panel on the development of a clinical research protocol

A research protocol is a document that outlines the proposed research idea and is submitted to funding agencies, institutions, or journals for approval. Writing a research protocol represents a challenge, particularly for early-career researchers. In this guide, we aim to provide detailed guidance with the key components and offer practical tips for crafting a research protocol in line with the various study designs. Specifically, the structure of a research protocol should contain the following items: (1) a title that is specific, catchy, and impressive within the word limitation; (2) an abstract that briefs the critical points of the study; (3) an introduction highlighting the study context from broad to narrow and defining the knowledge gap; (4) a justification underlining the significance of the proposed study; (5) Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) objective(s) and aim(s); (6) a methodology covering seven sub-items, including [i] study design and settings, [ii] study subjects, [iii] sample size calculation and sampling, [iv] participants recruitment and follow-up, [v] questionnaire development, [vi] potential variables and outcomes, and [vii] data analysis plan; (7) dissemination of the results; (8) ethics and conflict of interests; (9) budgets analysis/ funding disclosure; and (10) references. This guide will give an overview of these steps and provide clear and concise tips on how to successfully draft a scientific protocol. With careful planning and appropriate guidance, it is possible to develop a well-structured and compelling protocol to obtain approval for the conduction of the study or funding from agencies, institutions, or organizations.

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Publication Details

Journal
BMC Medical Research Methodology
Published
2024-11-29
DOI
https://doi.org/10.1186/s12874-024-02315-1
Citations
3
Primary Topic
Meta-analysis and systematic reviews
Type
article
Field-Weighted Citation Impact
1.38
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article

Tips from an expert panel on the development of a clinical research protocol

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3 citations
BMC Medical Research Methodology
Meta-analysis and systematic reviews
1.38
article

Tips from an expert panel on the development of a clinical research protocol

Sara S. Elsheikh, Atsuko Imoto, Omar M. Makram, Randa Elsheikh, Yasuhiko Kamiya, Nguyen Khoi Quan, Patrícia Takako Endo, Norio Ohmagari, Abdelrahman M Makram, Nguyen Tien Huy, Peter Lee, Hirotsugu Aiga, Nguyen Tran Minh Duc, Nguyen Hai Nam, Nguyen Thanh Van, Ngoc Quynh Tram Nguyen, Gibson Omwansa Javes
article en
3 citations

Abstract

A research protocol is a document that outlines the proposed research idea and is submitted to funding agencies, institutions, or journals for approval. Writing a research protocol represents a challenge, particularly for early-career researchers. In this guide, we aim to provide detailed guidance with the key components and offer practical tips for crafting a research protocol in line with the various study designs. Specifically, the structure of a research protocol should contain the following items: (1) a title that is specific, catchy, and impressive within the word limitation; (2) an abstract that briefs the critical points of the study; (3) an introduction highlighting the study context from broad to narrow and defining the knowledge gap; (4) a justification underlining the significance of the proposed study; (5) Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) objective(s) and aim(s); (6) a methodology covering seven sub-items, including [i] study design and settings, [ii] study subjects, [iii] sample size calculation and sampling, [iv] participants recruitment and follow-up, [v] questionnaire development, [vi] potential variables and outcomes, and [vii] data analysis plan; (7) dissemination of the results; (8) ethics and conflict of interests; (9) budgets analysis/ funding disclosure; and (10) references. This guide will give an overview of these steps and provide clear and concise tips on how to successfully draft a scientific protocol. With careful planning and appropriate guidance, it is possible to develop a well-structured and compelling protocol to obtain approval for the conduction of the study or funding from agencies, institutions, or organizations.

BMC Medical Research MethodologyVol. 24(1)
University of Debrecen (HU), Johns Hopkins University (US), Shiga University of Medical Science (JP), Duy Tan University (VN), Shiga University (JP), Zagazig University (EG), Augusta University (US), Johns Hopkins Medicine (US), Cho Ray Hospital (VN), Online Technologies (United States) (US), London School of Hygiene & Tropical Medicine (GB), National Center for Global Health and Medicine (JP), Stadtkrankenhaus Schwabach (DE), VinUniversity (VN), Oxford University Clinical Research Unit (VN), P N Lee Statistics and Computing (United Kingdom) (GB), October 6 University (EG), Nagasaki University (JP), Universidade de Pernambuco (BR), University of Edinburgh (GB)
Openalex Percentile: Top 16%
Meta-analysis and systematic reviews
1.38
DOIOpen Access PDFOpenAlex
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