1. Tips from an expert panel on the development of a clinical research protocol.
- Author
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Makram AM, Elsheikh R, Makram OM, Van NT, Nam NH, Quan NK, Duc NTM, Nguye NQT, Javes GO, Elsheikh SS, Imoto A, Lee P, Ohmagari N, Aiga H, Kamiya Y, Endo PT, and Huy NT
- Subjects
- Humans, Biomedical Research methods, Biomedical Research standards, Clinical Protocols standards, Surveys and Questionnaires, Research Design
- 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., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing of interests: The authors declare no competing interests., (© 2024. The Author(s).)
- Published
- 2024
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