Submission Guidelines

An overview of expectations for authors submitting a Data Note.

General Guidelines
Submission Process
SubmissionAll 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 editorial@ctdn.withpower.com.
Data Note Instructions
Overview
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).
Manuscript Formatting
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.
Data Access Requirements
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.
Main Manuscript Text Preparation
Title Page
Please include: the title of the article, which should include an accurate, clear and concise description of the reported work, avoiding abbreviations; and the full names, institutional addresses, e-mail addresses for all authors. It is acceptable to designate authorship as a Consortium or Project, if the author(s) prefer. 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.
Abstract (250 Word Max) 
The abstract must not exceed 250 words. Do not include abbreviations or references. Abstracts should be structured in two parts:
Data Description: Authors should provide a brief data description and describe why the data might be of value to other researchers.
Data Attributes: Authors should briefly outline the size and nature of the dataset included, while highlight which standards or ancillary datasets are referenced within the data.
Keywords
Between three and ten keywords representing the main content of the article.
Data Description
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. We recommend that the author consider structuring this portion of the manuscript as follows:
Context
Share the motivation for producing this data, while providing background on the area of research.
Methods
Authors may consider further decomposing this section into subheadings a) Sampling strategy and b) Steps. Methods may then be grouped under corresponding subheadings. This section should provide enough detail to allow other researchers to interpret and repeat the study.
Please include and cite the URLs (or DOIs) to any publicly available bioinformatics 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.
Data Validation
Demonstration of the dataset’s quality should be present within the manuscript. Data Notes can be published alongside traditional Research Articles, and any previous or in-press research using the data should be highlighted, as it will aid validation and demonstrate use.
Reuse Potential
Authors should highlight the downstream applications that may make use of their data. This section should highlight relevant standards and ancillary datasets which ensure the Data included is interoperable. 
Declarations
Consent, Competing Interests, Funding, & Acknowledgements
Please see our editorial policies for more details on declarations.
References
Consent, Competing Interests, Funding
Please see our editorial policies for more details on declarations.
Figures
Formatting Instructions for Figures
- Figures should be provided as separate files, not embedded in the main manuscript file.
- Each figure of a manuscript should be submitted as a single file that fits on a single page in portrait format.
- Tables should NOT be submitted as figures but should be included in the main manuscript file.
- Multi-panel figures (those with parts a, b, c, d etc.) should be submitted as a single composite file that contains all parts of the figure.
- Figures should be numbered in the order they are first mentioned in the text, and uploaded in this order.
- Figures should be uploaded in the correct orientation.
- Figure titles (max 15 words) and legends (max 300 words) should be provided in the main manuscript, not in the graphic file.
- Figure keys should be incorporated into the graphic, not into the legend of the figure.
- Each figure should be closely cropped to minimize the amount of white space surrounding the illustration.
- As an Open Access journal all figures, images and other media are published under the Creative Commons
- Please note that it is the responsibility of the author(s) to obtain permission from the copyright holder to reproduce figures (or tables) that have previously been published elsewhere.
Figure file types
- EPS (suitable for diagrams and/or images)
- PDF (suitable for diagrams and/or images)
- Microsoft Word (suitable for diagrams and/or images, figures must be a single page)
- PowerPoint (suitable for diagrams and/or images, figures must be a single page)
- TIFF (suitable for images)
- JPEG (suitable for photographic images, less suitable for graphical images)
- PNG (suitable for images)
- BMP (suitable for images)
- CDX (ChemDraw - suitable for molecular structures)
Figure size and resolution
Figures for display on web should observe a width of 600 or 1200 pixels (where the latter corresponds to high resolution images).
Figure compression
- 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
Formatting Instructions for Tables
- 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.
Additional Information
Additional Information Format
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 dataAdditional 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]'.
Supplementary Material
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.
Supporting Information
Author information
Full names and email addresses of all co-authors on your manuscript.
Cover Letter
A cover letter that includes the following information:
- A brief explanation of why your manuscript should be published in Clinical Trial Data Notes.
- A declaration of any potential competing interests.
- Confirmation that all authors have approved the manuscript for submission.
- Confirmation that the content of the manuscript has not been published, or submitted for publication elsewhere.
- If you are submitting a manuscript for a particular special issue, please indicate as much.
Ethics
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.

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