Study protocol

Criteria
Study protocol articles will only be considered for proposed or ongoing trials that have not completed patient recruitment at the time of submission. Please confirm the status of your study at submission.

If the study has already undergone full external peer review as part of the ethics approval or funding process, the study protocol will usually only undergo editorial peer review by the handling editor. Proof of both ethics and funding will be required, and we recommend that authors provide the relevant documentation on submission. Study protocols without major external funding will undergo full, external peer review. Study protocols without ethical approval will generally not be considered.


Preparing your manuscript
The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a ‘Declarations’ section including all of the subheadings (please see below for more information).

Title page
The title page should:

present a title that includes, if appropriate, the study design e.g.:
“A versus B in the treatment of C: a randomized controlled trial”, “X is a risk factor for Y: a case control study”, “What is the impact of factor X on subject Y: A systematic review”
or for non-clinical or non-research studies: a description of what the article reports
list the full names, institutional addresses and email addresses for all authors
if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
indicate the corresponding author
Abstract
The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

Background: the context and purpose of the study
Methods: how the study will be performed
Discussion: a brief summary and potential implications
Trial registration: If your article reports the results of a health care intervention on human participants, it must be registered in an appropriate registry and the registration number and date of registration should be in stated in this section. If it was not registered prospectively (before enrollment of the first participant), you should include the words ‘retrospectively registered’. See our editorial policies for more information on trial registration
Keywords
Three to ten keywords representing the main content of the article.

Background
The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study is necessary or its contribution to the field.

Methods/Design
The methods section should include:

the aim, design and setting of the study
the characteristics of participants or description of materials
a clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses
the type of statistical analysis used, including a power calculation if appropriate.
Discussion
This should include a discussion of any practical or operational issues involved in performing the study and any issues not covered in other sections.

List of abbreviations
If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations
All manuscripts must contain the following sections under the heading ‘Declarations’:

Ethics approval and consent to participate
Consent for publication
Availability of data and material
Competing interests
Funding
Authors’ contributions
Acknowledgements
Authors’ information (optional)
Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write ‘Not applicable’ for that section.

Ethics approval and consent to participate
Manuscripts reporting studies involving human participants, human data or human tissue must:

include a statement on ethics approval and consent (even where the need for approval was waived)
include the name of the ethics committee that approved the study and the committee’s reference number if appropriate.
Studies involving animals must include a statement on ethics approval.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

Consent for publication
If your manuscript contains any individual person’s data in any form (including individual details, images and videos), consent to publish must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent to publish.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

Availability of data and materials
All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
All data generated or analysed during this study are included in this published article [and its supplementary information files].
The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
Not applicable. If your manuscript does not contain any data, please state ‘Not applicable’ in this section.
More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here.

BioMed Central also requires that authors cite any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example: