Submission Guidelines

The Journal of Clinical Research Analysis, JoCRA, is an open-access, entirely digital, open data, and open peer review journal. Our focus spans data on clinical results, operations, methodology, and trends, with the end goal of making clinical trial data as a domain more comprehensible and interoperable. Our primary focus will always be Data Descriptors; however, we also accept Reviews, Commentary, Research, and Technical Notes, so long as they heavily reference openly available clinical data.

JoCRA was formed in response to the derth of legible, interoperable data surrounding most aspects of clinical trials — despite the fact that data production is the entire focus of our industry. While many highly impactful organizations are working to change this fact for future trials, there is tremendous latent opportunity to leverage — and make leverageable — historical clinical trial data.

To this end, our journal is unique along a number of dimensions, all of which are designed to develop positive incentives for contributors.

First, at the start of every year, our editorial board selects and shares the focus-areas for our monthly publications over the coming year. Our hope here is that we not-only the return-on-effort for would-be contributors, by helping them to improve their odds of placement, but also introduce a mechanism by which we can ensure that rare diseases are equitable beneficiaries of our collective efforts.

Second, we have gone beyond removing page or submissions fees, and instead award a $100-200 honorarium to all authors whose submissions are selected for publication, amount dependent on the length and nature of the publication. While we appreciate the nominal nature of this compensation, we believe that there is a large difference between ‘something’ and ‘nothing’, particularly given the increasingly precarious nature of pre-tenure academic employment. Authors whose works are selected for publication are also invited to edit and collaborate on other submissions in current and future issues, thereby improving collaboration and knowledge sharing within our community.

Third, we allow patient community members to sponsor similar awards for relevant research answering a question they’ve posed. All such awards & questions are anonymized and reviewed by our editorial team in accordance with our ‘community member award policy’ which prevents, among other things, any framing which might influence the methodology or results of said investigation.

The end result of these non-standard norms, we hope, will be a far greater velocity and volume of exploration, ultimately leading to better outcomes not only for patients, but for sponsors, CROs, and PI’s alike.

All manuscripts are submitted and reviewed via the journal's manuscript submission system. New authors should create an account prior to submitting a manuscript for consideration. Questions about submitting to the journal should be sent to the editorial office at jocra@withpower.com

In Clinical Trial Data Notes, Data Notes are designed to present highly-legible, interoperable data sets that have the potential to improve understanding for end users anywhere in the clinical trials value chain. The data described therein will be available via our ClinicalTrialDataDB data repository, and must align with FAIR Principles for scientific data.

Data Notes center a particular dataset, provide thorough methodology on data regarding production and validation, and highlight potential opportunities for reuse. If a manuscript contains more detailed biological, medical or technical analyses of data, the authors should instead submit a Research Article. 

Our aim with Data Notes is to incentivize the production and dissemination of useful data, even in cases where the author themselves does not plan to publish more detailed analysis, or believe this analysis will take a good deal more time.

Our Editorial process assesses the following:
- FAIR principle agreement, or how Findable, Accessible, Interoperable and Reusable the data is.
- Legibility, with respect to how comprehensible the data set is for patients, sponsors, and other would-be researchers.
- Comprehensiveness, considered in context of historically available data and limitations communicated by the author.
- Potential for reuse, either by sponsors, clinical research organizations, or patients. We prioritize datasets which are thoroughly documented, supported by metadata, and add value to similar data already available.

Our editorial team explicitly will not consider the following, so as not to disadvantage unglamorous contributions:
- Whether the data is rare or unusual in nature.
- Whether a novel methodology or technology was used to create dataset.
- Whether any subset of the data has been referenced in prior publications (so long as novel contributions to the dataset are present).

The following word processor file formats are acceptable for the main manuscript document:
- Microsoft word (DOC, DOCX)
- Rich text format (RTF)
- Portable document format (PDF)
- TeX/LaTeX (use OUP TeX template)
- DeVice Independent format (DVI)
If submitting via TeX, all editable sources are required so as to mitigate unnecessary publication delays.

Dataset(s) included within a Data Note must be available for our reviewers to assess along with the manuscript. This should be done via submission to our Clinical Trial Data Note Archive.

Following approval, said datasets must be made available under a Creative Commons CC0 waiver, without restrictions but subject to student opt-in to sharing the data. When submitting a dataset(s) which builds upon prior work, said prior work must be clearly referenced within a citation.

Clinical Trial Data Notes was built with large datasets in mind. There is no data processing or storage fee. The journal will provide a direct link from the published manuscripts to our Data Archive. Datasets will be provided with DOI’s following publication, in order to facilitate credit sharing and discoverability.

If you have sensitive data only appropriate for controlled-access databases (e.g. medical data), please indicate this when submitting your manuscript. When data therein has been consented to be openly shared, the editors may ask that you include an incomplete, unsigned version of the consent form alongside the data. You will also be asked to confirm that you have followed all national guidelines on data collection and release in the country the research was carried out. If you have any questions, feel free to reach out via editorial@ctdn.withpower.com.

Data submission is required at the point of manuscript submission, so as to minimize delays that are inevitable with multiple submission cycles or phases.

When submitting said data, you need to include sufficient description of said data, not just submission of the data alone. For this, please provide our team with the following information:

1. Descriptive, unique title for said data. This title typically begins with “The data for…”
2. Data Abstract:  a brief description of the dataset(s) included and their potential use for the scientific community.
3. Data Author(s): This can differ from that of the submitted manuscript.
4. Data Type(s): For example, adverse effect data, demographic data, transcriptome, imaging, movies, etc.
5. Data Size: An estimate of dataset size.
6. Readme File: The Readme should contain information about the files (to be) hosted in a dataset, including naming conventions and directory format of any zipped files.
7. Relevant Link(s): Hypertext links for any relevant data that is publicly available, or any related accession numbers in other repositories.
8. Acknowledgements: Please be sure to include a list of grants and funding agencies and information on consortium or projects if there are any associated with these data.

This should list: the title of the article, which should include an accurate, clear and concise description of the reported work, avoiding abbreviations; and the full names and institutional e-mail addresses for all authors. The corresponding author should also be indicated. It is suitable, should the authors of the work prefer, to designate authorship as a Consortium or Project. In such a case, a contact author must still be provided, and a complete author list/institutions/emails/etc should be included in the Authors' Contribution section.

The abstract must not exceed 200 words. Do not include abbreviations or references. Abstracts should provide a brief data description and describe why the data might be of value to other researchers. The abstracts should also briefly outline the size and nature of the dataset included, while highlighting which standards or ancillary datasets are referenced within the data. There are no specific formatting requirements for sections within the abstract, but context, relevance to the broader research landscape, and specific findings, should be highlighted.

Between three and ten keywords representing the main content of the article are required for submission. These keywords can be included below the main body of the abstract.

Please include background context and the purpose for collection of these data, with particular attention being paid to ensure this is comprehensible for readers without prior subject matter expertise. A clear, concise, description of the data, the protocol(s) for data collection, data curation and quality control, as well as potential uses should then follow.
While no specific section titles are required, we recommend that the author consider structuring this portion of the manuscript as follows:

Share the motivation for producing this data, while providing background on the area of research. All sources should be appropriately cited following citation style standards.

Authors should provide a detailed description of their data sources and any manipulation tools used to obtain the final sample, including software packages and versions. Rationale for methods choices should be provided throughout. This section should provide enough detail to allow other researchers to interpret and repeat the study.

The methods section should also include an overview of and rationale for any statistical analysis used to support the article’s findings. If no statistical analysis was performed, rationale for its absence should also be provided.

Please include and cite the URLs (or DOIs) to any publicly available datasets or other tools that are used in the production of the data, including the exact version used.

Authors may consider leveraging and sharing a link to their methods in protocols.io as these are in a structured form, allow inclusion of all details, are completely searchable unlike supplementary files, and can be updated to new versions as basic methodology changes over time.

Overall findings should be summarized and presented with an analysis of statistical significance, where appropriate. Final concluding remarks can also be included within the discussion. This section should be short and stick to primary findings of particular relevance to the field.

Please see our editorial policies for more details on declarations.

JoCRA follows the Chicago Manual of Style for all references. The citation guide outlines all citation requirements necessary for publication. Additionally, please be sure to follow Data Citation Principles when citing external data.

- Please submit each figure as a separate file. Include the corresponding author’s last name and figure number in the file name. The figures should be numbered in the order they appear in-text (i.e. Figure 1, Figure 2, etc). Do not imbed figures in the main manuscript.
- Each figure should fit on a single page in portrait mode. All figures should be uploaded in their correct orientation.
- Figures intended to be presented together (i.e. multi-panel figures) should be submitted as one file following the format the author would prefer in the final publication. All composite images should fit on one page in portrait mode.
- Figure captions should remain in the main manuscript, in the locations where the author would prefer the final images. The caption should include a description of the methods used to generate the figure, if they differ from the overall methods, as well as its general purpose. Figure titles are not necessary, but a descriptor (15 words or less at the beginning of the caption) is recommended.
- Figure keys should be included within the figure image, not the caption.
- Figures should be cropped to minimize the amount of white space surrounding the border.
- All figures should be the authors’ own intellectual property. No figures should be sourced from third-parties, including open-access sources. If a figure is citing data from other publications, the data must be presented in a novel way and cited in the figure caption.
- Tables should be uploaded as figures. Please submit an image (ie .png or .jpeg) of each table following the same document naming procedure as figures. Please note that the editors may change the format of the table slightly, but will not alter any content.
- As an Open Access journal all figures, images and other media are published under the Creative Commons Attribution (CC BY 4.0) license.
- Please contact email with any further questions about the figure and table submission process.

JoCRA accepts the following file formats for figures and tables:

- EPS
- PDF 
- JPEG 
- PNG 

Please contact us if you would like to submit figures of another file type.

Figures are resized during publication of the final full text and PDF versions to conform to the JoCRA standard dimensions, which are detailed below.
Figures on the web:
- Width of 600 pixels (standard), 1200 pixels (high resolution).
Figures in the final PDF version:
- Width of 85 mm for half page width figure
- Width of 170 mm for full page width figure
- Maximum height of 225 mm for figure and legend
- Image resolution of approximately 300 dpi (dots per inch) at the final size
Figures should be designed such that all information, including text, is legible at these dimensions. All lines should be wider than 0.25 pt when constrained to standard figure widths. All fonts must be embedded.

- Vector figures should if possible be submitted as PDF files, which are usually more compact than EPS files.
- TIFF files should be saved with LZW compression, which is lossless (decreases file size without decreasing quality) in order to minimize upload time.
- JPEG files should be saved at maximum quality.
- Conversion of images between file types (especially lossy formats such as JPEG) should be kept to a minimum to avoid degradation of quality.

- Tables should be numbered and cited in the text in sequence using Arabic numerals (i.e. Table 1, Table 2 etc.).
- Tables less than one A4 or Letter page in length can be placed in the appropriate location within the manuscript.
- Tables larger than one A4 or Letter page in length can be placed at the end of the document text file. Please cite and indicate where the table should appear at the relevant location in the text file so that the table can be added in the correct place during production.
- Larger datasets, or tables too wide for A4 or Letter landscape page can be uploaded as additional files. Please see [below] for more information.
- Tabular data provided as additional files can be uploaded as an Excel spreadsheet (.xls ) or comma separated values (.csv). Please use the standard file extensions.
- Table titles (max 15 words) should be included above the table, and legends (max 300 words) should be included underneath the table.
- Tables should not be embedded as figures or spreadsheet files, but should be formatted using ‘Table object’ function in your word processing program.
- Color and shading may not be used. Parts of the table can be highlighted using superscript, numbering, lettering, symbols or bold text, the meaning of which should be explained in a table legend.

Authors are free to include additional files that will be published alongside their submission. Please do not include: patient consent forms, certificates of language editing, or revised versions of the main manuscript document with tracked changes.

If additional material is provided, please list the following information in a separate section of the manuscript text:
- File name (e.g. Additional file 1)
- File format including the correct file extension for example .pdf, .xls, .txt, .pptx (including name and a URL of an appropriate viewer if format is unusual)
- Title of data
- Description of data
Additional files should be named "Additional file 1" and so on and should be referenced explicitly by file name within the body of the article, e.g. 'An additional movie file shows this in more detail [see Additional file 1]'.

If you have supplementary material for your article, please ensure every supplementary material file contains the phrase “supplementary material” as part of the actual file name. For example, “Figure A1_Supplementary Material.” This is important for production purposes so the files are published in the correct place.

A cover letter should be submitted as an additional file along with the main manuscript and figures. The cover letter should include the last name of the corresponding author and “CL” in its document title. The cover letter should include the following information, as well as any additional information that the authors deem relevant:

- Full names, institutional affiliations, and email addresses of all co-authors on the manuscript.
- Context and explanation (less than 150 words) of why the manuscript should be published in JoCRA.
- Outline all funding supporting each author in the presented research. Please include the names and numbers of all relevant grants.
- Note any issues relating to journal policies, along with an explanation and potential resolution.
- Note specific author contributions, if each author has different contributions.
- Declare any competing interests such as affiliations or funding.
- Confirm that all authors have approved the manuscript for submission.
- Confirm that the content of the manuscript has not been published, or submitted for publication elsewhere. Longer versions of the manuscript may be submitted to other journals following its publication in JoCRA, but this process may not begin until after publication.
- If you are submitting a manuscript to a particular special issue, please refer to its name or broad topic in the body of the letter.
- Please include any acknowledgements that you would like highlighted in the final publication.

Authors must observe high standards with respect to publication ethics as set out by the Commission on Publication Ethics (COPE). Falsifying or fabricating data, plagiarising or duplicating publication of the authors’ own work without proper citation, and misappropriation of the work are all unacceptable. Any cases of ethical misconduct are treated very seriously and will be dealt with in accordance with the COPE guidelines.