BMC Medical Research Methodology (Nov 2024)

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

  • 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

DOI
https://doi.org/10.1186/s12874-024-02315-1
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 10

Abstract

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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.

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