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

  1. Elsayid, Abdelrahman ORCID logo
  2. Elsheikh, Randa ORCID logo
  3. Elsayed, Omar ORCID logo
  4. Nguyen, Van Thanh ORCID logo
  5. Nam, Nguyen Hai ORCID logo
  6. Nguyen Khoi, Quan ORCID logo
  7. Nguyen Tran, Minh Duc ORCID logo
  8. Nguyen, Ngoc Quynh Tram ORCID logo
  9. Javes, Gibson Omwansa
  10. S. Elsheikh, Sara ORCID logo
  11. IMOTO, ATSUKO ORCID logo
  12. Lee, Peter ORCID logo
  13. Ohmagari, Norio ORCID logo
  14. Aiga, Hirotsugu ORCID logo
  15. Kamiya, Yasuhiko ORCID logo
  16. Endo, Patricia Takako ORCID logo
  17. Huy, Nguyen Tien ORCID logo

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1000 Titel
  • Tips from an expert panel on the development of a clinical research protocol
1000 Autor/in
  1. Elsayid, Abdelrahman |
  2. Elsheikh, Randa |
  3. Elsayed, Omar |
  4. Nguyen, Van Thanh |
  5. Nam, Nguyen Hai |
  6. Nguyen Khoi, Quan |
  7. Nguyen Tran, Minh Duc |
  8. Nguyen, Ngoc Quynh Tram |
  9. Javes, Gibson Omwansa |
  10. S. Elsheikh, Sara |
  11. IMOTO, ATSUKO |
  12. Lee, Peter |
  13. Ohmagari, Norio |
  14. Aiga, Hirotsugu |
  15. Kamiya, Yasuhiko |
  16. Endo, Patricia Takako |
  17. Huy, Nguyen Tien |
1000 Verlag BioMed Central
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-11-29
1000 Erschienen in
1000 Quellenangabe
  • 24(1):293
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s12874-024-02315-1 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606108/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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.
1000 Sacherschließung
lokal Surveys and Questionnaires [MeSH]
lokal Biomedical Research/methods [MeSH]
lokal Methods planning
lokal Humans [MeSH]
lokal Biomedical Research/standards [MeSH]
lokal Research protocol
lokal Research Design [MeSH]
lokal Clinical Protocols/standards [MeSH]
lokal Analysis planning
lokal Tips
lokal Grant proposal
lokal Research question
lokal Research
lokal Clinical research
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0003-2011-8092|https://orcid.org/0000-0002-5811-9907|https://orcid.org/0000-0001-8361-9068|https://orcid.org/0000-0002-4596-7034|https://orcid.org/0000-0001-5184-6936|https://orcid.org/0000-0002-3222-0978|https://orcid.org/0000-0002-9333-7539|https://orcid.org/0000-0002-4114-4997|https://frl.publisso.de/adhoc/uri/SmF2ZXMsIEdpYnNvbiBPbXdhbnNh|https://orcid.org/0000-0002-6053-9871|https://orcid.org/0000-0003-2744-6160|https://orcid.org/0000-0002-8244-1904|https://orcid.org/0000-0002-4622-8970|https://orcid.org/0000-0001-5910-3379|https://orcid.org/0000-0001-7190-1082|https://orcid.org/0000-0002-9163-5583|https://orcid.org/0000-0002-9543-9440
1000 Hinweis
  • DeepGreen-ID: 7fb30836e4c6443798f8b3bbe8cac928 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search) ;
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