Manuscript Preparation


General Submission Guidelines

Articles submitted to JSCDM should be scholarly and at the same time relevant to the practice, i.e., the management or use of data in the design, conduct or reporting of clinical studies. Review will be undertaken for articles conforming to a JSCDM article type, adhering to these submission guidelines, written in well-formed English grammar, and non-commercial in nature. Ultimately, readers must be able to make their own judgments regarding the applicability and quality of published information. It is therefore the policy of JSCDM that the methods employed to arrive at assertions in published work, the contributors to published work, and the relevant relationships and activities of all participants in the peer-review and publication process be completely and clearly articulated. 

JSCDM articles generally vary from 2 to 6 pages (~1000–4,000 words) in length depending upon the article type. Word counts exclude references, acknowledgements, conflict of interest statements, contributorship statements, funding statements, and the author’s affiliations. Authors planning to submit a longer article, should contact the editorial office. Length allowances can be made for articles of particular substance or relevance to the profession. Manuscripts may, where appropriate, include an acknowledgements section recognizing support not rising to the level of intellectual contribution required of authorship. 

JSCDM will consider the following types of articles. Guidelines for the content and format of each article type are listed below.

Article Submission Format and Process

Text Format

  • American Medical Association (AMA) style should be followed for all submissions. The Purdue Online Writing Lab (Purdue OWL) is an example of a website providing guidance regarding the AMA style in the section “AMA Style” under “Research and Citation Resources”.
  • Line Spacing: single-spaced, 10-12 pt. font, one blank line between paragraphs, one space between sentences
  • Margins: 1 inch from each side
  • Article Sections: depending upon article type described below
  • Format: MS Word preferred, or alternatively formatted as .txt

Graphics

  • Graphics should be included in the submission either in the text or appended to the end of the submission. If appended at the end, the desired placement of the graphic within the text should be specified, e.g., “insert Figure 1 here”.
  • References to the graphics should be indicated in the text (e.g. Figure 1), along with the appropriate citation for the source of the graphics. Permission to reprint must be included with the submission if the graphic is not original.
  • All graphics for accepted manuscripts (for publication) must be uploaded in one of the preferred formats include .jpg, .tif, or .gif.
  • Graphics (either electronic or printed) must be camera-ready and high resolution (at least 300 dpi) to ensure a high-quality image.

References

It is the author’s responsibility to ensure that all material drawn from other sources is credited, either as a footnote, an endnote and/or a reference. For example, all assertions not those of the author should indicate a source. Manuscripts will be screened for plagiarism using similarity detection tools. Learn more about SCDM plagiarism policies here

American Medical Association (AMA) style should be followed for references. The Purdue Online Writing Lab (Purdue OWL) is an example of a website providing guidance regarding the AMA style in the section “AMA Style” under “Research and Citation Resources”.

References should be cited in text as superscripts as numbers at the end of the sentence or paragraph with the corresponding number listed in the reference section. References should appear in the numerical order in the order they are cited in the body of the article. References may not be used in abstracts.

Copyediting and Typesetting

All published articles will be edited by the SCDM copy editor and professionally typeset. Questions to authors may arise during these last steps prior to publication. All articles require author approval of the final copy edited and typeset version prior to publication.

Manuscript Review Process

After a complete submission is received in the journal management system, the corresponding author and all other authors will receive a confirmation email. Within three working days, the submission will be reviewed by the Editorial Office. Well-written submissions that are within the journal’s scope and of apparent scholarly rigor will be assigned to an Associate Editor. The assigned Associate Editor will communicate with the corresponding author through the Journal Management system and will manage and preside over the peer-review process. The Associate Editor managing the review will assign reviewers with expertise relevant to the submission. Reviewers will be selected so that scientific and scholarly rigor as well as relevance and applicability to practice are covered in the review. Scientific reviewers will review articles for scholarly and methodological rigor. Clinical Research Informatics and Data Management professionals will review manuscripts for their relevance and direct applicability to the practice of data handling in clinical research. Selection and invitation of reviewers is at the discretion of the JSCDM.

Reviewers will have the option to disclose identity but are not required to do so. Author identity will be known to reviewers. Reviewers will apply review criteria relevant for the article type and will (1) provide a categorical rating for each review criteria, (2) provide constructive comments supporting the categorical rating to the authors for improving the article’s suitability for the journal and (3) make an overall recommendation regarding acceptance, revision or rejection of the submission. The Associate Editor managing the review will resolve any disagreements between reviewers, provide summary review comments to the corresponding author through the Journal Management System and make an overall decision regarding acceptance, revision or rejection of the submission. Review decisions will be expected within two weeks and will fall into one of three categories: Accept, Revise and resubmit, or Reject. Resubmission of revised manuscripts will be expected within two weeks. Revisions will be received by the Associate Editor managing the review. The Associate Editor managing the review will review the author’s responses to the review comments and will attempt to return the revised submission to the initial reviewers in cases where an additional review round is needed. An additional review round is recommended where it is not clear if the author has been responsive to the review comments or proposes a different approach to address the reviewer’s concern. The same timelines apply for revisions, however, we expect that revisions would in-general be responsive to review comments and therefore have shorter review and revision times. Associate Editors may review the revision themselves where they are qualified to judge the author’s responsiveness to the review comments. Outside of extenuating circumstances, the judgement of which is at the discretion of the JSCDM, submissions not reaching an accept or reject decision after the third round of review will be rejected.

Reviewers and Editorial Board Members will receive 0.25 Continuing Education Units towards certification renewal for each submission reviewed. Authors will receive 0.25 Continuing Education Units towards certification renewal for each article accepted for publication.

Manuscript Production Process

After a submission has received an accept decision, the article will automatically be entered into the production queue in the Journal Management System. The first step is copy editing. Upon an accept decision, JSCDM Editorial Office staff are notified and assign a copy editor. Copy editing entails assuring that the article is free from grammar and spelling problems, clear, concise, and that the article conforms to the American Medical Association (AMA) Manual of Style 11th Edition. The copy editor is allotted a standard two weeks for copy editing. Copy editing occurs in Microsoft Word software using the files submitted by the author. The suggested revisions from copy editing will be returned to the author through the Journal Management System for review and approval. Authors should not make substantive revisions at this point; the purpose of copy editing is for grammar, clarity, complete references, concision, and conformance to the current version of the AMA Manual of Style. Thus, corresponding author comments on the copy-edited version should be limited to providing information requested by the copy editor and correcting instances where the copy editing inadvertently altered the meaning of the text or introduced an error. The main article text, appendices, table, listing and figure titles and captions, and references will be copy edited. Journal supplementary material such as shared datasets and computer programs will not be copy edited.

Upon author approval of the copy edit marked-up version, the JSCDM Editorial Office staff will receive an alert in the Journal Management System that the copy editing process is complete. The Editorial Office will assign a Typesetter and indicate that the author-approved versions are ready for typesetting.

The typesetting process converts the copy edited MS Word files into a professionally formatted pdf document as well as an extensible markup language (xml) file. The pdf version is the version that will ultimately be downloadable from the JSCDM site. The xml version is the version used to render the article on-line in the JSCDM site for on-line reading. JSCDM-specific stylesheets are used for xml rendering and leverage the article metadata maintained in the Journal Management system. Thus, changes to article metadata during the production process must be made in the Journal Management System as well as on the MS Word version of the article. The typesetting process is allotted a standard time of two weeks, after which, the author is provided the typeset pdf and xml versions for a final review through the Journal Management System. Once the corresponding author indicates approval of the typeset version, the article will be subject to a final review by the Editorial Office and the Associate Editor managing the review and then published immediately on-line. Full-text article formats available for each article include pdf and xml. All content is fully available as open access for web searching and crawling. On a quarterly schedule, articles published since the last issue will be compiled into an issue on the Journal Website and at that time will receive the full citation metadata including the volume and issue identifier.

Quality Control

All articles undergo similarity checks with available web content. The Journal adheres to the Society for Clinical Data Management plagiarism policy in addition to a code of ethics. Other than letters, All JSCDM articles are subject to semi-structured peer-review relevant to the article type. Article types subject to peer-review outside the Editorial Board are marked with the Peer-reviewed designation on the published versions. All JSCDM articles undergo professional copy editing and type setting. Authors review and approve the copy edited and typeset versions of all articles prior to publication.

The Journal maintains operational metrics for internal evaluation and improvement. Metrics to be maintained and publicly shared include the following: publication counts by article type, article citation statistics, article view and download statistics, average number of weeks between initial submission and publication, average number of review-iterations, and acceptance rate of manuscripts by article type. Manuscripts written at the request of the Journal and articles solicited from individuals, while subject to external, peer-review, are not included in the acceptance rate.

Ethics

JSCDM adheres to the SCDM Code of Ethics and the International Committee of Medical Journal Editors (ICMJE) guidelines except where noted in the Editorial Policies. JSCDM strives to uphold ethical standards in scholarly publication. As such, works involving human subjects require a statement of ethical oversight such as approval by an Institutional Ethics Committee or Institutional Review Board (IRB) or a determination of non-research or non-human subjects research from an ethical oversight body. Human subjects research requires a description of the informed consent process or declaration of waiver of consent or waiver of documentation of consent. The identifier from the ethics oversight body should be included in the manuscript. In addition, works describing or using data from Clinical Trials are required to have registered the study in CT.gov or author’s national registry prior to the enrollment of the first subject. The registry identifier for the trial should be included in the manuscript.

All articles include a statement of contributorship and a statement of sources of financial support for the work described in the article.

A statement of non-overlapping publication or content with other published works, works in press and works under review is required at the time of submission. JSCDM will not consider content under review elsewhere. All works under review are considered confidential until publication.

The Journal requires that all participants, for example, Editorial Board Members, Reviewers and Authors disclose conflicts of interest and competing interests, financial or otherwise. Associate Editors are asked to disclose at the time of invitation to accept an Editorial Assignment; conflicts declared by potential Associate Editors including but not limited to competing interests, collaboration with an author in the previous three years, a current supervisory or subordinate relationship with an author, working at the same organization with an author, or financial interest in the manuscript, are requested to decline the Editorial assignment in response to the invitation. In the event a COI surfaces during a managed review, Associate Editors are given a final opportunity to declare a COI on the review rubric. Similarly, invited reviewers are asked to disclose at the time of invitation to accept an Review Assignment; conflicts declared by potential reviewers including but not limited to competing interests, collaboration with an author in the previous three years, a current supervisory or subordinate relationship with an author, working at the same organization with an author, or financial interest in the manuscript, are requested to decline the review assignment in response to the invitation. In the event a COI surfaces during a review, reviewers are given a final opportunity to declare a COI on the review rubric. Conflicts of interest disclosed by the authors on the submission form are automatically published with the article as stated by the authors.

The Journal encourages the inclusion of supplemental material with published articles such as computer programs and datasets. Supplemental materials are subject to external peer review and must be submitted with the manuscript. All data obtained from or about humans must be de-identified or shared under the provisions on a HIPAA Authorization. JSCDM encourages adding language about sharing of even de-identified data in the informed consent. Appropriate de-identification remains the responsibility of the author.

To support research reproducibility and replication, authors are encouraged to share methods, data and documentation to the maximum extent possible. Articles where the author is unable to provide documentation or data in response to an expression of concern will be subject to retraction including publication of an explanatory retraction notice. Expressions of concern will be brought to the attention of the authors for resolution and where not fully resolved by the authors, formally considered by a committee of Editorial Board members.

Errors happen and we encourage transparent reporting and handling of errors. Errors discovered post-publication may result in a published correction or may necessitate a retraction. Publication of expressions of concern, published corrections, and retractions occur at the discretion of the JSCDM.

All complaints and expressions of concern should be made in writing to the Chief Editor, Meredith Nahm Zozus, PhD, CCDM at the JSCDM Editorial Office: info@scdm.org The Journal will respond to all reasonable complaints and expressions of concern.