Protocol articles
Study protocol
What is a study protocol?
Study Protocols are a peer reviewed article type that describe in detail high level/large scale study design, including (but not limited to) experimental design of basic and applied research, or protocols defining research questions and empirical methods. Study Protocols should be submitted for publication prior to the research activity beginning. For detailed descriptions of experimental procedures (laboratory or computational) please submit using the laboratory protocol article type.
What are the benefits of publishing a study protocol?
Increases visibility
Makes research plans discoverable to a wider audience
Provides researchers with a citable publication for their detailed protocol
Enhances research transparency
Increases overall transparency of research methodology and planned procedures
Reduces publication bias by documenting research plans before results are known
Prevents selective reporting of research outcomes in resulting publications based on favorable results
How do I write a study protocol?
Study Protocols should be written in clear, precise language with sufficient detail to allow reproduction by other researchers.
Read tips on writing your abstract.
Read making your article more discoverable, including information on choosing a title and search engine optimization.
For most Study Protocols, the following standard format will be the most appropriate:
Introduction
Protocol
Conclusions/Discussion
Please include a clear rationale for the study, as well as a detailed description of the protocol, including:
Methods: How the sample is to be selected; Interventions to be measured; Sample size calculation – i.e., expected number of participants to make the outcome significant; Primary outcomes to be measured, as well as a list of secondary outcomes; Data collection, management and analysis, statistical method(s) to be used.
Ethics: Details of any ethical issues relating to the study; statement to indicate that informed consent of the subjects has been obtained (where relevant) and that ethical approval has been received from the institution or funder.
Dissemination: Plans for dissemination of the study outcome (including the associated data) once completed.
Reporting guidelines
Declaration of interest statement
This is to acknowledge any financial or non-financial interest that has arisen from the direct applications of your research. Further guidance on what is a conflict of interest and how to disclose it.
Data availability
In general, this article type should not include new research and data. Depending on the journal’s data sharing policy, authors may be required to provide a data availability statement, even where there is no data associated with the article. In this instance, the data availability statement should read:
“No data are associated with this article.”
References
You must reference all sources.
Tables and figures
Figures should be supplied in one of our preferred file formats: PS, JPEG, TIFF, or Microsoft Word (DOC or DOCX) files are acceptable for figures that have been drawn in Word. For information relating to other file types, please consult our Submission of electronic artwork.
Tables should present new information rather than duplicating what is in the text. Readers should be able to interpret the table without reference to the text.
Ethics and consent
All research must be conducted within an appropriate ethical framework. Details of approval by the authors’ institution or an ethics committee must be provided in the Methods section of the Study Protocol. Please refer to the detailed ‘Ethics’ section in our editorial policies for more information.
Clinical trials
If the study protocol relates to a clinical trial then the Trial registration details must be provided: name of registry, registry number, registration date and URL of the trial in the registry database. We support the public disclosure of all clinical trial results (as mandated in the US FDA Amendments Act, 2007), for example on a public website such as clinicaltrials.gov. The disclosure of results on such sites does not preclude the publication of articles reporting and/or analyzing the same datasets. For further details about trial registration, see our editorial policies.
Further resources
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