Manuscript Preparation


Table of Contents

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. Articles should conform to an accepted article type, follow these submission guidelines and be written in English.

Articles should be non-commercial in nature. Advertisements are welcome as paid content and will be clearly distinguished from scholarly content. For more information on advertising opportunities in JSDCM or other SCDM publications and events please visit the advertising section of the SCDM website.

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, contributorship, funding statements, and author’s affiliations. If an author wishes to submit a longer article, please 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.  For effective abstract writing guidance, please refer to the article "Preparing a Successful Scientific Abstract for Professional Meetings in the Data Sciences" by Richard F. Ittenbach, PhD, PSTAT; Alexander C. Bragat, PMP, Susan K. Howard, MSN.

  • Original research
  • Review articles
  • Design manuscripts
  • Case study and demonstration project reports
  • Education and professional development articles
  • Topic briefs and perspectives

Article Types

Original Research

Original research articles should describe independent research involving the design, conduct and reporting of clinical studies or the sharing of resources from them. Research articles need not be limited to hypothesis-driven research and can include original descriptive studies in which information is brought together for the first time to shed light on current problems or issues within clinical data management. Original research can include many different study designs including experimental, quasi-experimental, econometric, and survey designs as well as qualitative studies, and historiographies.

Research article abstracts should be structured and contain the following sections: introduction, objectives, methods, results and conclusions. The main text of the article should include the following sections: introduction, background, methods, results, discussion and conclusions. Limitations of the research should be clearly stated.

Word count limit: 4000 words

Structured abstract word count limit: 250 words

Table limit: 4

Figure limit: 6

References: required and unlimited

Review Articles

Review articles usually report systematic reviews of the literature and may report pooled or meta-analysis, quantitative or qualitative synthesis including scoping reviews and best practice tutorials on topics of broad interest to the readers.

Review article abstracts and text should follow the same format required of research articles described above. All systematic reviews should contain information commonly reported in a PRISMA diagram and the submission should include the PRISMA Statement checklist (http://prisma-statement.org/). If the review is a best practice tutorial, the structured abstract should contain the following sections: Learning objectives, Target Audience, and assessment/s in addition to the research sections.

Word count limit: 4000 words

Structured abstract word count limit: 250 words

Table limit: 4

Figure limit: 6

References: required and unlimited

Design Manuscripts

Design manuscripts describe the research design and methods planned or used in a study. Evaluation plans for methods, systems or procedures may also be reported in this way. These are often published during the conduct of the study and comprehensively describe, as in the case of a protocol summary, the research problem statement and research questions, the research approach and rationale, setting in which the research is conducted, research and experimental design, methods and procedures used to conduct the research. Design manuscripts should indicate the point in the research process at which the manuscript was written and must include a statement regarding plans for sharing the research results and lessons learned. The structured abstract for a research design manuscript should contain the following sections: Study objectives, Research design, Methods for study conduct, and Results sharing plans.

Word count limit: 2000 words

Structured abstract word count limit: 250 words

Table limit: 3

Figure limit: 2

References: required and unlimited

Case Studies and Demonstration Projects

Case studies and reports of demonstration projects describe the demonstration or implementation of a novel approach, technology, method or processes or application of existing ones in new areas. Case reports may consist solely of a detailed description of the initial implementation of a new method or technology or characterize an innovative implementation in a well described context. Strong case reports will include evaluation or validation of the system, intervention or process and a credible synthesis of lessons learned. Case studies in particular companies may be accepted if the article thoroughly describes the context to support a reader’s ability to assess applicability to settings of interest. Case studies should not be commercial in nature, i.e., should not appear to endorse or advertise a particular firm.

Case study and demonstration project structured abstracts and manuscripts should use the same sections articles reporting original research.

Word count limit: 4000 words

Abstract word count limit: 250 words

Table limit: 4

Figure limit: 6

References: required and unlimited

Education and Professional Development

Education and professional development articles present the development, structure, delivery, evaluation and analysis of education and professional development programs. Model programs and curricula are also encouraged. Articles of this type may also themselves be a concise tutorial on a focused topic relevant to the profession. Tutorials should adhere to best practices in instructional design and be accompanied by learning objectives or outcomes as well as assessments to aid learners.

Word count limit: 4000 words

Abstract word count limit: 250 words; structured abstract not required

For tutorials: also include a statement of target audience, learning outcomes and assessment/s

Table limit: 4

Figure limit: 6

References: required and unlimited

Topic Briefs and Perspectives

Topic briefs and perspectives report opinions or views of thought leaders on topics of importance to broadly applicable to clinical research informatics and data management including new policy, regulation, technology, success or failure of initiatives, and current challenges ripe for research. Perspective articles may focus on current advances and future directions on a topic, and may include original data. Opinion articles may also be reported as perspectives and present a consensus or the author’s viewpoint on strengths and weaknesses of practices, methods or technology. Opinion articles often challenge and prompt critical discussion of current practices or knowledge.

These articles may contain varying sections including thought leader interviews.

Word count limit: 2000 words
Abstract word count limit: 150 words; structured abstract not required
Table limit: 2
Figure limit: 3
References: unlimited

Letters to the Editor

The Journal will consider publication of letters to the editor as a mechanism for readers to submit comments, questions, dissenting opinion or criticisms about published articles. Authors will be given the opportunity to respond letters regarding specific manuscripts. Letters to the Editor will be copy edited and typeset and published upon submitter’s approval. Letters may not be subject to peer review.

Text Format

  • 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

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 edited and typeset version prior to publication.

Manuscript Submission Process

Submissions are accepted on a rolling basis. Submit manuscripts and accompanying materials through the Journal Management System. The system will walk you through all of the material and information needed to submit your manuscript. The following file types are allowed for upload: pdf and MS Word files for text and .jpg, .tif, or .gif files for high resolution figures.

As much information as possible is captured as structured data during the submission. This information, for example, manuscript title, authors, author affiliations and emails, Conflict of Interest disclosure, funding acknowledgement, key words, is carried forward with the article through the review and if accepted, the publication and indexing processes. This rich metadata is published with the article and helps make the article more discoverable in the internet. Therefore, please have the following information ready at the time of submission.

  1. Article title
  2. Author(s) name (first, MI, surname), degrees and/or nationally recognized professional certification designations
  3. Author ORCiD (required for the first author only but recommended for all authors)
  4. Author affiliation with complete mailing address, telephone and fax numbers, and e-mail address
  5. Article Keywords (see the Keywords section for details)
  6. Be prepared to mark a statement that the article has been read and approved by all authors. This is required for compliance with International Committee of Medical Journal Editors (ICJME) guidelines. All authors will receive a confirmation email from the Journal Management System that the article has been submitted and will receive copies of all decision emails.
  7. Corresponding Authors are encouraged to include their social media links such as Linked-in, Twitter, etc. We encourage links to published articles.
  8. A Conflict of Interest (COI) statement is required for all authors. The COI form in the Journal Management System is completed by all authors and requires listing interests relevant to the manuscript, e.g., financial interests, funding or other sponsorship for the work described in the article, affiliation, financial, or intellectual property interest in with products or companies mentioned in the manuscript. Information disclosed on the conflict of interest form will be appended to all articles.
  9. A Release from the corresponding author releasing copyright to SCDM. This form requires that the author has undergone any organizational legal or other review prior to submission for publication.
  10. Authors recommendations for reviewers and their email addresses
  11. The manuscript being submitted for review. The manuscript file must include references and all tables, listings and figures referenced in the text. A statement of contributorship for each author. The following list is recommended: study design, study conduct, data collection, data management, data analysis, or contribution to manuscript drafts.
  12. Manuscripts reporting work funded directly by a grant, contract or corporate support require disclosure and recognition of the support in a funding statement. Grant or contract numbers are required for manuscripts receiving support from United States Federal funding source.

Supplemental materials including long listings, data collection forms, other study or documentation, or data offered by the authors to be publicly shared with the manuscript should be submitted as separate files. If accepted for publication, these materials will be listed on-line as supplemental material to the manuscript.

Article Keyword Guidelines

Authors are requested to submit a set of keywords with each article to improve searchability and information retrieval.

  • Provide between 3 to 6 keywords, inclusive.
  • Choose keywords that represent the main subject matter of your article.
  • At least one keyword from the SCDM controlled terminology should be used. Additional keywords from the broader Biomedical domain from the Medical Subject Headings (MeSH) controlled vocabulary may also be used.

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.

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 Editorial Board member. The assigned Editorial Board member will communicate with the corresponding author through the Journal Management system and will manage and preside over the peer-review process. Reviewers will have the option to disclose identity but are not required to do so. Author identity will be known to reviewers. All articles will be assigned two or more external reviewers with expertise in the main topic of the submission will be assigned to each 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. Reviewers will apply relevant sections of the review criteria and will (1) provide constructive comments to the authors for improving the article’s suitability for the journal and (2) make an overall acceptance recommendation. The Editorial Board Member 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 suitability of the manuscript. Review decisions will be expected within one month and will fall into one of three categories: Accept, Revise and resubmit, or Reject. Resubmission of revised manuscripts will be expected within three weeks. Revisions will be received by the Editorial Board member managing the review and will make every attempt to return the revised submission to the initial reviewers if needed. 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. 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 electronic Journal Management System. The first and automatic step is Copy Editing. The Journal benefits greatly from a Copy Editor with experience in Clinical Research Data Management spanning both industry and academically oriented studies. 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, and concision of writing. 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. After author approval of the copy edit marked-up version, the article will be sent for typesetting. The author will be provided the typeset version for a final review through the Journal Management System. Once the corresponding author indicates approval of the typeset version, the article will be automatically published. Full-text article formats available for each article include PDF, HTML, and XML. All content is fully available 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 and external peer-review and the Society maintains plagiarism policies in addition to a code of ethics. The Journal has retained the services of a Copy Editor with many years of Data Management experience and utilizes professional type setting. Authors review and approve release of all articles for 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, clicks per individual advertisement, average number of weeks between initial submission and publication, average number of review-iterations, acceptance rate of manuscripts. 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 International Committee of Medical Journal Editors (ICJME) guidelines, the SCDM Code of Ethics and 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 received 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 registration in ClinicalTrials.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. Disclosed conflicts are automatically published with the article.

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 of the applicable Personally Identifiable Information (PII) laws, such as HIPAA Authorizations or following the General Data Protection Regulations (GDPR). We encourage 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.

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: Jscdm@scdm.org. The Journal will respond to all reasonable complaints and expressions of concern.