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. 2024 Nov 29;24(1):293.
doi: 10.1186/s12874-024-02315-1.

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

Abdelrahman M Makram #  1   2   3 , Randa Elsheikh #  4   5 , Omar M Makram  6   7   5 , Nguyen Thanh Van  8   5 , Nguyen Hai Nam  9   10   5 , Nguyen Khoi Quan  11   12   5 , Nguyen Tran Minh Duc  13   5 , Ngoc Quynh Tram Nguyen  14   5 , Gibson Omwansa Javes  15   5 , Sara S Elsheikh  16   5 , Atsuko Imoto  15 , Peter Lee  17 , Norio Ohmagari  18 , Hirotsugu Aiga  15 , Yasuhiko Kamiya  15 , Patricia Takako Endo  19 , Nguyen Tien Huy  20   21   22   23
Affiliations

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

Abdelrahman M Makram et al. BMC Med Res Methodol. .

Erratum in

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.

Keywords: Analysis planning; Clinical research; Grant proposal; Methods planning; Research protocol; Research question; Tips.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing of interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Schematic representation of the critical components of a successful research protocol
Fig. 2
Fig. 2
Example of a Gantt chart for a clinical research study protocol. Different tasks of the research project should be listed, and the approximate duration of each task should be highlighted. Tasks differ according to the chosen study design. In long studies, a “year” section might be added
See this image and copyright information in PMC

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