Tips from an expert panel on the development of a clinical research protocol
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 w...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Language: | English |
| Published: |
BioMed Central
2024
|
| _version_ | 1824458590795071488 |
|---|---|
| author | 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 Huy, NT |
| author_facet | 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 Huy, NT |
| author_sort | Makram, AM |
| collection | OXFORD |
| description | 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. |
| first_indexed | 2024-12-09T03:26:20Z |
| format | Journal article |
| id | oxford-uuid:6906f468-df62-457e-8b3d-5c509ac8758f |
| institution | University of Oxford |
| language | English |
| last_indexed | 2025-02-19T04:28:19Z |
| publishDate | 2024 |
| publisher | BioMed Central |
| record_format | dspace |
| spelling | oxford-uuid:6906f468-df62-457e-8b3d-5c509ac8758f2024-12-09T20:03:46ZTips from an expert panel on the development of a clinical research protocolJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:6906f468-df62-457e-8b3d-5c509ac8758fEnglishJisc Publications RouterBioMed Central2024Makram, AMElsheikh, RMakram, OMVan, NTNam, NHQuan, NKDuc, NTMNguye, NQTJaves, GOElsheikh, SSImoto, ALee, POhmagari, NAiga, HKamiya, YEndo, PTHuy, NTA 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. |
| spellingShingle | 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 Huy, NT Tips from an expert panel on the development of a clinical research protocol |
| title | Tips from an expert panel on the development of a clinical research protocol |
| title_full | Tips from an expert panel on the development of a clinical research protocol |
| title_fullStr | Tips from an expert panel on the development of a clinical research protocol |
| title_full_unstemmed | Tips from an expert panel on the development of a clinical research protocol |
| title_short | Tips from an expert panel on the development of a clinical research protocol |
| title_sort | tips from an expert panel on the development of a clinical research protocol |
| work_keys_str_mv | AT makramam tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT elsheikhr tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT makramom tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT vannt tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT namnh tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT quannk tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT ducntm tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT nguyenqt tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT javesgo tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT elsheikhss tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT imotoa tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT leep tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT ohmagarin tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT aigah tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT kamiyay tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT endopt tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol AT huynt tipsfromanexpertpanelonthedevelopmentofaclinicalresearchprotocol |