The Association of Clinical Research Professionals

Clinical Researcher

Clinical Researcher is ACRP’s flagship journal, published six times a year and featuring peer-reviewed articles on the latest developments across the spectrum of specialty areas in the clinical research enterprise, as well as highlighting valuable insights and resources from columnists, internal and external news sources, and the Association’s partner organizations.

February 2016

Individual articles coming soon!

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April 2016

Individual articles coming soon!

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Individual articles coming soon!

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August 2016

Individual articles coming soon!

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Individual articles coming soon!

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February 2015

Individual articles coming soon!

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April 2015

Individual articles coming soon!

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June 2015

Individual articles coming soon!

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August 2015

Individual articles coming soon!

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October 2015

Individual articles coming soon!

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December 2015

Individual articles coming soon!

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June 2014

Coming soon!

August 2014

Coming soon!

October 2014

Coming soon!

December 2014

Coming soon!

About Clinical Researcher

Each issue of Clinical Researcher offers nursing and medical continuing education credits through Home Study tests for Members’ professional development needs, and includes content for myriad facets of the clinical research enterprise.

The majority of the peer-reviewed articles in most issues focus on specific themes, as outlined in the Editorial Calendar, and articles are both solicited and accepted unsolicited from authors globally on topics that target the full range of the Members’ skill levels.

Clinical Researcher also includes information on product and service providers from across the clinical research spectrum.

Although most of the regular bimonthly issues are available to Members only, each year at least one issue is made available to the public at no cost and features either clinical research career-related articles or collected perspectives on broad topics of general interest to the research community and its stakeholders.

Permissions
Clinical Researcher is a fully copyrighted publication. For permission to photocopy or use material electronically from Clinical Researcher [ISSN 2334-1882], please access www.copyright.com or contact the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, 978.750.8400.

Home Study

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests, an exclusive ACRP Member benefit.

Delivered through ACRP’s flagship journal, Clinical Researcher, Home Study tests are accredited to provide 3.0 contact hours/credits (ACRP, CBRN, ACCME).

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Editorial Advisory Board

The Editorial Advisory Board (EAB) holds responsibility to contribute to and support the publication of Clinical Researcher as the preeminent resource for peer-reviewed articles about the clinical research profession and to provide members of ACRP with news and information that enhances their professional development as members of the clinical research enterprise.

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Editorial Staff

James Michael Causey, Editor-in-Chief, joined the ACRP staff in 2015, and has been a healthcare journalist for nearly 20 years. As the Editorial Director at FDAnews, he ran an eight-person newsroom and was a frequent contributor to Clinical Trials Monitor, among many other publications. He’s also the author of “50 Best Practices for Clinical Trials: Lessons for Sponsors and Sites” (FDAnews 2012), and “Clinical Trials: Ensuring Patient Safety and Integrity,” (FDAnews 2006). Outside the clinical trials industry, he’s written for PhRMA, blogged about medical devices for AssuRx, and helped to develop webinar content addressing the full spectrum of the healthcare marketplace.

Gary W. Cramer, Managing Editor since 2016, joined the ACRP staff in 2006 as an Editor/Writer and later was promoted to Associate Editor. A 1987 graduate of The Pennsylvania State University, he has also worked as a daily newspaper reporter in Lancaster, Pa., in public/media relations and donor communications for Penn State, and as a writer/editor for Landscape Architecture Magazine from the American Society of Landscape Architects. For ACRP, he also serves as editor of the weekly CRbeat e-newsletter, general editor for training/development and certification resources, and staff liaison to the Regulatory Affairs Committee.

Editorial Calendar

February 2017 Education and Training/Make Your Studies Smarter
April 2017 Technology
June 2017 Quality in Clinical Research
August 2017 Sites
October 2017 Regulatory/Compliance
December 2017 Careers in Clinical Research

Please contact Editor-in-Chief James Michael Causey for the latest updates: editor@acrpnet.org or 703.253.6274.

Submit an Article

Writing an article for Clinical Researcher is an excellent way to boost your professional development, gain recognition, share important information about the latest developments in clinical research with fellow professionals around the world, and help ACRP maintain its role as the leading voice and information resource for clinical research professionals everywhere.

Anyone can write for Clinical Researcher. Reviewers serving on the ACRP Editorial Advisory Board will consider any article, by anyone, on any subject pertinent to clinical research, anytime it is submitted. So start writing!

Please review the information found under the “Author Guidelines” and “Writing Tips” options on this site, and then visit http://www.edmgr.com/CLINRESEARCHER/default.aspx to use the online peer-review system devoted to Clinical Researcher. If you have any questions, please e-mail editor@acrpnet.org.

Author Guidelines

Writing an article for Clinical Researcher is an excellent way to boost your professional development, gain recognition, share important information about the latest developments in clinical research with fellow professionals around the world, and help ACRP maintain its role as the leading voice and information resource for clinical research professionals everywhere.

Anyone can write for Clinical Researcher. The Editorial Advisory Board will consider any article, by anyone, on any subject pertinent to clinical research, anytime it is submitted. So start writing!

Please review the following information about submitting an article for Clinical Researcher. If you have any additional questions, please e-mail editor@acrpnet.org.

The Peer Review Process

The Editorial Advisory Board (EAB) reviews all articles for relevancy, accuracy, organization, objectivity, and integrity. Your proposal or article will be reviewed by two or more members of the EAB in a completely confidential, double-blind process; that is, you will not know who your reviewers are and they will not know who you are. The time frame for the review process depends on a number of variables, including the availability of reviewers who have the expertise to review the topic presented and the current production schedule. As a result, the review process may take longer than the usual two to four weeks. ACRP cannot guarantee placement in Clinical Researcher, but the EAB considers all submissions seriously and makes every effort to review articles fairly and provide detailed, constructive feedback as needed.

In accordance with the peer review guidelines of the International Committee of Medical Journal Editors, the EAB reviewers read each article in an effort to determine if the paper is original and/or scientifically important, if it exhibits brevity and clarity, if it presents adequate interpretation, and if it draws appropriate conclusions. Thus, they address the following questions and indicate whether there is a need for revisions:

  • Is the point of the article original and/or important, and well-defined? After reading the manuscript, reviewers ask themselves if they have learned something new and if there is a clear conclusion to the article.
  • Are the data (if any) sound and well controlled? Reviewers will indicate if they feel that inappropriate controls have been used, explaining the reasons for their concerns, and suggesting alternative controls where appropriate.
  • Is the discussion well balanced and supported by the data? The discussion should be relevant to the point and unbiased. It should not be overly positive or negative. Conclusions should be valid, with reference to other relevant work as applicable. Reviewers will ask the author(s) to provide specific examples if this is not the case.
  • Have the authors provided references wherever necessary? Reviewers will ask authors to provide references for any statements that require them. When authors have provided references, reviewers will look to see if the reference seems appropriate for the statement.
  • Do the title and abstract describe the work accurately? The title and abstract are the most frequently read sections of any article; therefore it is vital that they accurately describe it in a clear, balanced manner. Also, the title should be as brief as possible, while still conveying the point in an enticing manner.
  • Can the writing, organization, tables, and figures be improved? Although the editorial team may also assess the quality of the written English, reviewers will comment if they consider the English in the submission to be below the standard that is expected for Clinical Researcher. If the manuscript is organized in such a manner that it is illogical or not easily accessible to the reader, reviewers will suggest improvements in a concrete manner. They will also provide feedback on whether any data are presented in the most appropriate manner; for example, if a table is used when a graph would give increased clarity; if the figures are of a high enough quality to be published in their present form; or if numerous text items might be better presented as a bulleted list or in a table.
  • Are there any ethical, promotional, or competing interest issues? Reviewers will comment if the work seems promotional or commercial in any way.

If accepted for publication, articles are published in the next available issue. Submissions may be held for use in an issue that presents many articles on the same theme. See below for the editorial schedule and deadlines for upcoming issues. Note, however, that the EAB will review any article on any clinical research topic any time it is submitted.

Authorship Criteria

Authorship credit should be based on:

  1. substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; and
  2. drafting the article or revising it critically for important intellectual content; and
  3. final approval of the version to be published; and
  4. agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work were appropriately investigated and resolved.

Authors must meet all four conditions, and all who qualify should be listed as authors. All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support. Groups of persons who have contributed materially to the paper but whose contributions do not justify authorship may also be acknowledge. Because readers may infer their endorsement of the data and conclusions, these persons must give written permission to be acknowledged.

Submission Requirements

  • Preferred article length: up to 2,500 words, accompanied by an abstract of no more than 150 words.
  • Submissions must be originals and submitted exclusively to Clinical Researcher. Authors of accepted articles must sign a copyright release, granting ACRP all rights to future publication and distribution in print and electronic forms.
  • Articles may be based on research, data, new developments, or informational topics. Review articles may be considered, but contact the Editor prior to your submission for guidance.
  • ACRP reserves the right to edit the content of the article.
  • Submissions must not be commercial or in any way convey self-interest or promotion.
  • EAB reviewers may ask the writer to revise the article according to their recommendations.
  • Insert reference numbers manually within the text. Do not use automatic footnoting and referencing. Reference all sources at the end of the article. Clinical Researcher uses a modified University of Chicago Press reference style. Basically, each reference must list all authors, publication year, article title, and full name of journal with volume, issue, and page numbers. If the citation is published on the Internet, provide the full URL pathway for readers to access it.
  • Figures and tables are allowed, but those from previously published material must be submitted with a letter from the author or publisher granting permission to publish in Clinical Researcher. Any fees associated with reprinting must be paid by the author prior to publication of the article in Clinical Researcher.
  • Electronic images should be high-resolution files (at least 300 to 600 dpi) with captions.

Clinical Researcher uses the PeerTrack submission and peer review system. Prospective authors should log in or register (if new to the site) at www.editorialmanager.com/clinresearcher and follow the instructions to fill in the contact information required by the system. You should upload articles in Microsoft Word, 12 point Times Roman, double spaced. Make certain that there is no author information inside the article file(s). The system will assign an article number and convert the file to a pdf, which the author must approve before it is ready for peer review.

How Many Figures?

The word-limit (2,000-2,500 words) produces four print pages, the average length of an article in Clinical Researcher. One or two figures on one page is fine; more than that looks “cluttered” and is hard for readers to follow. With the three-column format, any large (screenshot) figure will span at least two columns, and still might not be readable.

Transfer of Copyright Form

The Transfer of Copyright Form provides ACRP with the right to publish your articles and must be submitted to editor@acrpnet.org, or via fax to James Michael Causey, Editor-in-Chief, at 703.254.8102.

Writing Tips

DO:

  • Start by telling the readers what the paper is going to discuss and why. In other words, tell readers what your paper is going to talk about, and tell them what you expect them to take away from reading it.
  • Spell out all acronyms and abbreviations the first time you use them. Then use the acronyms and abbreviations consistently after that. Even editors have to look up things like AAHRPP, CISCRP, and CDISC, and since Monitor issues get passed around from ACRP members to nonmembers, many readers (especially those from other countries) will not necessarily know a CRA from a CRC unless you explain it to them.
  • Use the full, correct names of any organizations. For example, OHRP is not the Office of Human Research Protections; it is the Office for Human Research Protections. Little errors like this make it look as if you are not being careful about your sources.
  • Watch time references. A reference to “this year” or “next year” in the article you submit in October might be incorrect when we publish it in February. Be specific.
  • Explain the basic facts about infamous problematic research, whether modern or historic, if you must refer to it. Do not assume that everyone will readily remember or understand what the TeGenero incident was, why Tuskegee is an example of unethical practices, or that thalidomide was never approved in the U.S., etc.
  • Document the source of any statistics – where acquired and how old the data are, because timeliness and reliability are important to readers. A five-year old estimate of how much research activity is expected in a particular region based on a small survey from a marketing firm is quite different from a one-year old estimate based on a large survey by an independent nonprofit firm.
  • Stick to the facts. Qualitative phrases that betray your personal feelings belong in opinion articles, not in peer-reviewed pieces describing professional practices.
  • Be accurate about ACRP’s structure, events, certifications, etc., if mentioning it in your article. We often must correct authors on such basic items as the kinds of certifications we offer, the full name of our conference, etc.
  • Make your article gender neutral as much as possible. “First-in-man,” “mankind,” and “manpower” become “first-in-human,” “humankind,” and “labor,” for example, and not all doctors are “he.”
  • Make a conclusion that reiterates the point of the paper and summarizes the takeaway points.
  • Illustrate with tables, figures, and bulleted or numbered lists where appropriate. They break up the text and are easier for people to grasp. Give each figure/table a name and a number and reference it in the text. It cannot – and probably will not – fall exactly where it is mentioned in the text. (So step-by-step explanations with figures, which work so well in slide presentations, don’t work very well in print.) Visualizing the article in print will help.
  • Use subheads to break up the text – not too many, but definitely a few.
  • Reference your sources as appropriate. Use sequential numbers in the text, and list the references at the end (numbered correspondingly in order of appearance). Ensure that the citations and the reference list match, and verify all references against the original sources. Each reference must start by listing all authors, then year of publication, title of article, and full journal name followed by volume and issue numbers and page numbers.

DON’T:

  • Don’t use first person.
  • Don’t try to be “formal”; just write the paper. The peer reviewers will give you advice and guidance on how to improve and polish it. If it is accepted, your paper will then get copyedited at the headquarters office. So do not be too concerned about how you say something; be more concerned about what you have to say.
  • Don’t put two spaces after a period. Removing dozens or hundreds of extra spaces from your article can be awkward and time consuming.
  • Don’t use regionally idiosyncratic phrases or pop culture references; they will not mean anything to readers in other countries.
  • Don’t make promotional statements that refer to your company or your product or otherwise promote a specific company or product in any manner.

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