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

Autor: Abdelrahman M. Makram, Randa Elsheikh, Omar M. Makram, Nguyen Thanh Van, Nguyen Hai Nam, Nguyen Khoi Quan, Nguyen Tran Minh Duc, Ngoc Quynh Tram Nguye, Gibson Omwansa Javes, Sara S. Elsheikh, Atsuko Imoto, Peter Lee, Norio Ohmagari, Hirotsugu Aiga, Yasuhiko Kamiya, Patricia Takako Endo, Nguyen Tien Huy
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMC Medical Research Methodology, Vol 24, Iss 1, Pp 1-10 (2024)
Druh dokumentu: article
ISSN: 1471-2288
DOI: 10.1186/s12874-024-02315-1
Popis: 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.
Databáze: Directory of Open Access Journals
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