AG-T10: Study Protocol — Pre-Registered Methodology and SPIRIT-Compliant Design for GMJ
A Practical Guide to Writing and Submitting Study Protocols Before Data Collection
Keywords:
study protocol, SPIRIT 2013, pre-registration, clinical trials, research methodology, ethics approval, IRB, statistical analysis plan, primary outcome, research design,, GMJ AcademyAbstract
The GMJ Author Toolkit (AG-T10) provides a structured, self-contained guide for the preparation and submission of Study Protocol manuscripts in accordance with international reporting standards and publication ethics. A Study Protocol is a peer-reviewed document describing the complete methodology of a planned study, submitted prior to data collection.
The guide is organized into three components: (1) theoretical foundations explaining the purpose of protocol publication, including research transparency, prevention of outcome switching, and reduction of publication bias; (2) a comprehensive pre-submission checklist covering mandatory elements such as ethics approval, trial registration, and SPIRIT 2013 guideline compliance; and (3) a complete worked example demonstrating protocol structure, including administrative information, methodological detail, sample size calculation, and statistical analysis planning.
Particular emphasis is placed on mandatory pre-registration, ethics committee approval prior to submission, and full specification of primary outcomes and analysis plans. The toolkit aligns with SPIRIT 2013 recommendations and international best practices for clinical and observational research protocols.
By combining methodological rigor with clear guidance, this resource supports authors in producing high-quality, publication-ready Study Protocols for the Georgian Medical Journal.
References
[1] Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
[2] International Committee of Medical Journal Editors (ICMJE). Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals [Internet]. 2023. Available from: https://www.icmje.org/
[3] Posadzki P, Watson LK, Alotaibi A, Ernst E. Prevalence of use of complementary and alternative medicine. BMC Complement Altern Med. 2013;13:147.
[4] Pkhakadze G. Georgian longitudinal study reference, 2024.
[5] World Medical Association. Declaration of Helsinki. JAMA. 2013;310(20):2191-4.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Giorgi Pkhakadze
This work is licensed under a Creative Commons Attribution 4.0 International License.
This article is published open access under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence.
You are free to: share and adapt the work for any purpose, even commercially.
Conditions: provide appropriate credit to the authors and the Georgian Medical Journal (GMJ), link to the licence, and indicate if changes were made. Do not apply legal terms or technological measures that legally restrict others from doing anything the licence permits.
Licence: creativecommons.org/licenses/by/4.0 · Legal code: creativecommons.org/licenses/by/4.0/legalcode
Third-party material. Images or other content credited to a third party are not covered by CC BY 4.0; permission must be obtained from the rights holder for reuse beyond statutory exceptions.
Authors' rights. Authors retain copyright. First publication rights are granted to GMJ.
Data and code. Where provided, datasets or code may carry their own licences; please follow the licence stated in the article or repository record.
Listen on Spotify
Apple Podcasts
YouTube
Amazon Music
Castbox
Pocket Casts
LinkedIn
Facebook
X
Instagram
Substack
Bluesky
ResearchGate
