Study protocol articles will generally only be considered for proposed or ongoing trials that have not completed participant recruitment at the time of submission. Trials advises that study protocols are submitted well before recruitment completes, however we will also on occasion consider study protocols submitted before the last patient/last visit. This, including an explanation of why it was not possible to submit earlier, should be included within the manuscript text. Please confirm the status of your study at submission.
Trials also considers study protocols assessing aspects of the design, conduct or reporting of randomized trials. These studies do not necessarily need to be trials and include studies such as core outcome set development for use in trials and process evaluations that run alongside trials. Please follow the relevant reporting guideline for the study design and include the corresponding checklist as an additional file. The online protocol template called SEPTRE (SPIRIT Electronic Protocol Tool & Resource) is a web-based option to create, manage, and register protocols using the SPIRIT guidance.
All submitted protocols must have ethical approval. If the study has undergone full external peer review as part of the funding process, the study protocol will usually only undergo editorial peer review by the handling editor. Study protocols without major external funding will undergo full, external peer review. Study protocols without ethical approval will generally not be considered. To support efficient handling of your study protocol, the Editors advise that prospective authors familiarize themselves with this Editorial on what is expected in a study protocol submission.
On submission, the following documentation should be uploaded as Additional Files. If the original documents are not in English, an English translation of each is mandatory.
- Ethical approval document
- Copy of the original funding documentation
- A completed SPIRIT checklist (unless the structured study protocol template has been used), or checklist for another appropriate reporting guideline
Trials requires the submission of a populated SPIRIT checklist and figure for all clinical trial study protocols, except those submitted using the optional structured study protocol template. The SPIRIT 2013 Statement, 33-item checklist and figure can be downloaded here. The figure should be included in the main body of the text and the checklist should be provided as an additional file, both the figure and the checklist should be referenced in the text. Submissions received without these elements will be returned to the authors as incomplete.
It is understood that for some study protocols certain aspects may not comply fully with the SPIRIT checklist. The checklist will not be used as a tool for judging the suitability of manuscripts for publication in Trials, but is intended as an aid for authors to clearly, completely, and transparently let reviewers and readers know what authors intend to do. Where an item is not applicable, authors can state this but must also add a brief explanation as to why the item is not applicable. Eg. Biological Specimens, Item no. 33: Not applicable, no samples collected. Simply saying ’N/A’ will lead to the manuscript being returned.
Using the SPIRIT guideline to write the study protocol, completing the SPIRIT checklist, and constructing a SPIRIT figure are likely to optimize the quality of reporting and make the peer review process more efficient.
Authors submitting to Trials can now opt-in to a service called In Review, which provides a pre-print service, meaning the article can be shared with funders and others in a citeable way while it is under review. It also provides authors with on-demand information on the status of their manuscript, enables them to share their work with funders and others, and allows their wider community to comment and collaborate - all whilst their manuscript is under review. Please see here for full details.