Editorial Policies

Submission of a manuscript implies that the underlying dataset is not under consideration for publication elsewhere and that, if accepted, it will not be published elsewhere in the same form. Please note that data shared with pre-print servers, or made available only to conference attendees, are still a valid for submission.

In the case that a manuscript includes previously published figures or text exceeding 150 characters in length, then it is expected that the copyright holder's written permission will be obtained and included in your submission. To this end, the editorial team may choose to apply plagiarism checking software as they see fit.

All authors must have participated materially in the work such that they can take public responsibility for the content. Authorial credit implies substantial contribution to either the conceptual or practical elements involved in building said data set. Authors aught to be involved in drafting the article and revising it critically for important intellectual content. Importantly, all authors must have read and approved the final version of the manuscript. It is expected that authors will adhere to the recommendations of the International Committee of Medical Journal Editors (ICMJE). In nearly all circumstances, requests to revise authorship following submission acceptance will be denied.

Contributors failing to meet the criteria for authorship may be included in an 'Acknowledgements' section. Common roles that are deserving of acknowledgement, but insufficient to qualify for authorship, include: purely technical assistance; copy writing or editing; or faculty members who provided insights which were generally instructive, but not highly specific to the data at hand.

Editorial team members treat all manuscripts submitted with confidence, with strict adherence to COPE’s Ethical Guidelines for Peer Reviewers. Manuscripts sent for peer review are confidential documents and will remain so until formally published.

When submitting a manuscript, Clinical Trial Data Notes stipulates that authors must reveal financial interests and connections whether indirect or direct. Further, authors are expected to raise any other context that might suggest bias in their manuscript. Examples here include funding sources for the authors themselves or their broader department, personal relationships, or direct academic competition. Authors with a direct tie to organizations which sponsor clinical trials are expected to adhere to Good Publication Practice guidelines for pharmaceutical companies.

A useful test for conflict of interest is: Is there any agreement that would embarrass any of your co-authors in the case that it was to emerge after publication and you had not declared it? Submitted manuscripts must include a ‘competing interests’ section listing any and all competing interests (whether financial or non-financial). In the case that authors have no competing interests, the statement should read “The author(s) declare(s) that they have no competing interests”. The Editor may ask for further information relating to competing interests.

It should go without saying that research involving human subjects, human material, or human data, must have been performed in accordance with the Declaration of Helsinki and must have been approved by a relevant ethics committee. When relevant, all manuscripts must include the name of said ethics committee as well as the reference number where appropriate. In the case of exemption, this should be detailed in the manuscript (including the name of the ethics committee that granted the exemption). Editors may request further information and documentation as they see fit. Manuscripts may be rejected if the Editorial Team deems that the research has not been carried out within an appropriate ethical framework. In rare cases, the Editor may contact the ethics committee for further information.

Following acceptance, authors may be asked to provide additional files for the final manuscript to the Editorial Team. These files are used for typesetting and should either be in Microsoft Word or a Google Docs file. Final manuscript should not contain information regarding the volume or issue in which the article will appear, as this may confuse readers accessing the article online (prior to the issue's formal release).

When dealing with potential cases of misconduct the journal follows the guidelines provided by the Committee on Publication Ethics.

Peer-review is the system used to assess the quality of a manuscript before it is published. Independent researchers in the relevant research area assess submitted manuscripts for originality, validity and significance to help editors determine whether the manuscript should be published in their journal. You can read more about the peer-review process here.

Clinical Trial Data Notes operates via a single-anonymized peer-review system, where the reviewers are aware of the names and affiliations of the authors, but the reviewer reports provided to authors are anonymous. This format is the traditional model of peer review that most reviewers are comfortable with, and has a history of facilitating dispassionate critique of a manuscript. Prior to peer review, the Editorial Team assesses all Manuscripts to determine which are worthy of peer review. All published articles, including Data Notes, are peer-reviewed. Overall editorial responsibility for the journal is with the Editor, with Editorial Board Members acting as handling editors.

Clinical Trial Data Notes fully supports “open science” mechanisms for disseminating research. Like many others, we believe that the Ingelfinger Rule limits important discourse and slows our collective ability to learn. To this end, authors are encouraged to present their findings and data to their peers prior to submission.

Further, we strongly encourage the use of open preprint services servers such as arXiv, bioRxiv, medRxiv, and OSF Preprints. Preprints may be cited where appropriate within manuscript references, and will not be considered in the evaluation of the conceptual advance of a manuscript submitted for publication.

All data central to a Data Note should be available to readers via our Data Archive. Clinical Trial Data Notes fully embraces the National Academies recommendations regarding data sharing. Please see Board on Life Sciences, Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences for more details.

Following successful approval for publication, the accompanying datasets must be accessible by any researcher wishing to use them under a Creative Commons CC0 waiver. Supporting the maximal reusability means that, authors are expect to conform to field-specific standards for the preparation and recording of data. When in doubt, turn to FAIRSharing for information on such data standards. Further, manuscripts must ensure to maintain patient confidentiality. For relevant examples, consider turning to either the Re3data registry or ELIXIR's list of Core Data Resources.

Authors are required to include a “Data Availability” statement within their manuscript. This statement must detail where the data referenced in their Data Note can be found. Clinical Trial Data Notes embraces the Force 11 Data Citation Principles and so requests that all publicly available datasets be fully referenced in the reference list.

It is paramount that authors respect their ethical and legal responsibility to maintain participant anonymity when sharing a clinical data set. Authors must demonstrate that publication of such data does not compromise anonymity or confidentiality or breach local data protection laws, for the dataset to be considered for publication. Authors must consider whether the dataset contains any direct or indirect identifiers and consult their local ethics committee or other appropriate body before submission if there is any possibility that participants will not be fully anonymous. Authors must state in their manuscript on submission whether informed consent was obtained for publication of patient data, and copies of unsigned consent forms may be required for inspection upon submission.

Clinical Trial Data Notes takes seriously all allegations of potential misconduct. In cases of suspected research or publication misconduct, it may be necessary for the Editor to contact and share manuscripts with third parties, for example, author(s)’ institution(s) and ethics committee(s). The Editorial Team may also seek guidance from COPE. In cases of proven research misconduct involving published articles, or where the scientific integrity of the article is significantly undermined, articles may be retracted.

Clinical Trial Data Notes uses plagiarism detection software. If plagiarism is identified, the COPE guidelines on plagiarism will be followed.

Clinical Trial Data Notes adheres to COPE guidelines regarding appeals to editorial decisions and complaints.