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In this issue, we offer up a variety of perspectives on ways to improve, broaden, and deepen the business aspects of the clinical research enterprise for the benefit of all its stakeholders. Included are welcome contributions from Ireland and the European Union on some big-picture topics, and focused columns that bring us valuable glimpses into such specialized areas as patient recruitment and retention, data management, digital therapeutics, decentralized trials, dose optimization, and more.
The September issue of Clinical Researcher investigates “Soft Skills and Hard Choices on the Clinical Research Radar,” with a focus on matters tied to best practices for research workplace interactions, work/life balance, quality management, and more.
The August issue of Clinical Researcher focuses on topics that are “Overlooked No More,” and offers insights from thought leaders on leveraging lesser-known roles, designs, and tactics for success in the clinical research enterprise.
The July issue of Clinical Researcher invites you to consider “Opening New Doors on a Protean Process,” with a focus on articles and insights from clinical research thought leaders on the modern state of informed consent practices and how they are evolving to meet future demands.
The May issue of Clinical Researcher explores “Careers and Challenges Behind the Clinical Trials Technology Curtain” through a collection of articles and columns from clinical research thought leaders on some of the most pressing workforce and workplace transformations taking place today.
The April issue of Clinical Researcher delivers new perspectives on “Diversity, Equity, and Inclusion in Clinical Research? We Can Do It!” from thought leaders across the spectrum of the research enterprise.
The March issue of Clinical Researcher focuses on timely research workforce and leadership development topics and asks, “Does the World Recognize the Clinical Research Professional in Your Mirror?”
The January issue of Clinical Researcher gathers scholarly articles and timely columns under the theme, “Changed for the Better: A Brave New World for Researchers and Patients in 2021,” including advice for patient recruiters, new or would-be chief medical officers, Clinical Trial Agreement negotiators, and more.
The December issue of Clinical Researcher delivers “Reviews and Previews: Upbeat Investigations of Recent and Upcoming Innovations in Clinical Research,” including predictions on what’s ahead for various aspects of the research enterprise like institutional review boards, diagnostics development, and technology services.
The November issue of Clinical Researcher offers up “Career Advice from Research Veterans,” an overview of trends in clinical research education and training, and viewpoints on other timely topics in the research enterprise.
The September issue of Clinical Researcher races your way with the theme of “Good Study Streamlining Practices: Speeding (Safely) for the Finish Line,” and delivers insights on a variety of practices for accelerating and improving different aspects of clinical trial conduct without sacrificing patient protections.
The August issue of Clinical Researcher ponders how we should go about “Rethinking Risk, Race, and Other Urgent Issues in Clinical Research,” and features articles and columns on risk-based management, patient diversity, remote and decentralized trials, and more.
The June issue of Clinical Researcher considers the second half of the old saying about “The More Things Change…” through articles and columns on training, career development, trial conduct, data handling, and change management in the clinical research enterprise.
The May issue of Clinical Researcher presents “Lessons Learned for Research Access, Safety, and Human Subject Protections” in the midst of the coronavirus crisis and other challenges to individual and public health.
The April issue of Clinical Researcher looks at tools and tactics devoted to “Aiming for Accuracy in the World of Subject Recruitment,” including considerations for coordinator productivity metrics, behavior change strategies, social media usage, and impacts from the COVID-19 crisis.
The issue of Clinical Researcher invites you to consider “Starting Off on the Right Foot” when strategizing on various technological and process-oriented approaches to study start-up challenges.
The February issue of Clinical Researcher draws your attention to “Research Studies and Studying Research: Designing a Better Tomorrow,” offering a mix of articles and columns on training and competencies for research staff and on how certain specialized study types or approaches are meant to function.
The January issue of Clinical Researcher dives into a variety of billing/financial, paperwork, data reporting, and managerial challenges at study sites under the theme of “Rising Expectations in Research: Are You Sinking or Swimming?”
The December issue of Clinical Researcher presents a traveler’s guide to “Rules and Regulations: Staying on the Straight and Narrow,” with insights of value to PIs, CRCs, CRAs, and more.
The November issue of Clinical Researcher considers the challenges of “Charting Early and Changing Career Courses” through a variety of columns and peer-reviewed articles.
The September issue of Clinical Researcher offers perspectives on “Breaking New Ground in Recruitment and Management for Trials” from a variety of first-time and returning contributors to the journal.
The August issue of Clinical Researcher focuses on the importance of “Connecting the Research Community” through better uses of powerful real-world data, thoughtfully developed publications, standardized technologies and skillsets, and more.
The June issue of Clinical Researcher delivers “Insights and Imperatives” on a variety of evergreen best practices for clinical trial teams to ponder—not so much ones they could adopt as ones they should adopt.
The May issue of Clinical Researcher shares a variety of perspectives on “Mapping the Way to Site Success” through technology adoption, complexity tool usage, and more.
The April issue of Clinical Researcher delivers insights on “The Nuts and Bolts of Clinical Trials”—tactics and chores for beginners in trials or that few people think about…until the person who understands them best goes missing.
The March issue of Clinical Researcher offers insights from industry thought leaders on the importance of finding your financial footing in the clinical research enterprise.
The February issue of Clinical Researcher takes aim at the wide-ranging topic of adverse events in clinical trials—defining them, evaluating them, training those who report them, and more.
The January issue of Clinical Researcher considers data and technology trends in the clinical research enterprise that, ready or not, you’re already part of.
The December issue of Clinical Researcher delivers fresh insights on research ethics, including everyday situations in which you can see these ethics in action.
The November issue of Clinical Researcher considers the importance of meshing the gears of education and training in support of a stronger clinical research workforce.
The September issue of Clinical Researcher focuses on how paying attention to the bonds between different roles on the clinical trials team makes for a stronger whole.
The August issue of Clinical Researcher highlights new perspectives on the recruitment and retention of volunteer subjects for clinical trials and other hot topics in the clinical research enterprise.
The June issue of Clinical Researcher targets a variety of principal investigator concerns tied to the managerial and technological domains of maintaining a robust clinical research enterprise.
The May issue of Clinical Researcher looks “behind the scenes” of clinical trials to consider some of the processes influencing study conduct that often go unnoticed, yet which are critical to quality outcomes.
The April issue of Clinical Researcher delivers lessons on the whats, hows, and whys of institutional review boards (IRBs) and academic medical centers (AMCs), and covers other timely topics in the research enterprise.
Contributors to the March 2018 issue approach the theme of privacy in clinical research from the viewpoints of multiple stakeholders in the enterprise. Also included in this issue is an introduction to the ACRP Class of 2018 Fellows.
The February 2018 issue of Clinical Researcher focuses on the role of project management in clinical trial conduct. Topics include why today’s project leads need to evolve their roles as part of strategic contract research organizations and more.
The January 2018 issue of Clinical Researcher challenges everyone on the clinical trials team to be involved in patient recruitment and retention. Peer-reviewed articles cover study participants as consumers, surveying participant experiences, the “unified clinical” concept, and more.
The December 2017 issue of Clinical Researcher focuses on careers in clinical research, and how they can evolve in both expected and unexpected ways. Our clinical research careers are not stagnant. They change, but what makes them change? Do we take steps as individuals to do it ourselves, or do external forces push us along?
The October 2017 issue of Clinical Researcher focuses on how regulations and compliance expectations benefit the entirety of the global clinical research enterprise. There are more similarities than differences in the conduct of research, whether it is a drug or a device product, or a U.S.-based study versus one conducted elsewhere.
The August 2017 issue of Clinical Researcher considers tactics and triumphs from study sites on the front lines of the research enterprise. Virtually all other organizations are connected to, or dependent on, sites: sponsors, contract research organizations, institutional review boards, electronic data capture vendors, and more.
The June 2017 issue of Clinical Researcher looks at a variety of challenges researchers face when applying quality improvement efforts to clinical trials. Quality improvement is a formal approach for the analysis of performance and systematic efforts to improve it, and is distinct from quality control and quality assurance.
The April 2017 issue of Clinical Researcher focuses on technology-related trends and insights in data management, regulatory expectations, study coordination, and more for the clinical research enterprise. There’s no escaping the impacts of new and improved technology on the conduct of clinical trials.
The February 2017 issue of Clinical Researcher features tactics for making your studies smarter while also meeting industry demands to make them faster, cheaper, and more efficient. The peer-reviewed content includes articles on quality assurance coordinators, investigational drug management, reporting adverse events, and more.
The December 2016 issue of Clinical Researcher spotlights why workforce development is important and why it should be an ongoing priority for all clinical research professionals. A skilled workforce is essential, and the only way it can be accomplished is through education and ongoing professional development.
The October 2016 issue of Clinical Researcher focuses on some of the many barriers that exist to achieving increased research efficiency at study sites. Peer-reviewed content includes articles on remote monitoring, informed consent, investigator-initiated research, marketing research within your organization, and more.
The August 2016 issue of Clinical Researcher looks at performance improvement to help describe the selection, use, and interpretation of metrics in research. Understanding performance and components which define performance improvements helps us to describe the appropriate selection, use, and interpretation of metrics.
The June 2016 issue of the Clinical Researcher helps you keep pace with technological trends happening in the research enterprise. While it can be exciting to see how technology makes impacts us professionally, we also need to think about how technologies are regulated and how they can affect human subjects protections.
The April 2016 issue of Clinical Researcher celebrates ACRP’s 40th anniversary and looks to the future of the clinical research enterprise. In addition to peer-reviewed content, this issue features special contributions on “living the research life,” three “givens” that will always drive successful drug development, and more.
The February 2016 issue of Clinical Researcher issue considers the past, present, and future of ethical issues at sites and beyond. Ethical issues arise in innumerable aspects of clinical research. Various ethical constructs and codes direct and support clinical research and form the basis for most of the regulations.
The December 2015 issue of Clinical Researcher looks at tips and trends for clinical research careers. These careers are increasingly sought after thanks, in part, to a booming biotechnology industry bringing new products to market and prompting high demand for many positions tied to drug and device discovery.
The October 2015 issue of Clinical Researcher covers the clinical research revenue cycle and understanding research finance. Functional areas throughout the research management process act sequentially on a participant’s visit, adding critical information required for procuring payment from sponsors and third-party payers.
The August 2015 issue of Clinical Researcher tackles clinical studies and activities that could be considered “outside the box.” The classic, four-phase drug development model is just the tip of the iceberg one finds when delving deeper into the field, building a career, and sometimes, even realizing a dream.
The June 2015 issue of Clinical Researcher offers insights on risk management/mitigation and optimal performance in trials. Among other factors, clinical trials of any phase have become increasingly demanding due to higher complexity of study protocols, the data to be collected, and the extent of documentation required.
The April 2015 Clinical Researcher brings to light many different aspects of patient centricity in trials. Although it may seem obvious that the ultimate goal of clinical research is to improve patients’ lives, this patient-centric view is sometimes either overlooked or forgotten when it comes to trial implementation.
The February 2015 issue of Clinical Researcher focuses on integrating research into the practice of healthcare. Throughout their evolution, clinical research and the healthcare industry have become more intertwined, with a diverse array of interactions, changes, and applications of thinking affecting their relationship.
The December 2014 issue of Clinical Researcher offers a variety of global regulatory insights for clinical researchers. Clinical research for pharmaceutical and medical devices on a global scale is an area of high complexity. This includes regulations, local laws, and guidance documents that have been developed in recent decades.
The October 2014 issue of Clinical Researcher spotlights international topics and human subject protections. Among other articles, you will find those that focus on research challenges in England, Latin America, and India; on trends in patient advocacy, informed consent, and investigator’s brochures; and more.
The August 2014 issue of Clinical Researcher tackles multiple angles of building quality into the clinical research enterprise. Clinical research can be an extremely fast-paced and high-pressure environment. When we add the regulatory requirements of study execution, it can be easy to lose sight of why we do it in the first place.
The June 2014 issue of Clinical Researcher addresses achieving excellence in research through education and training. Regulations, guidance, and ethical codes of conduct specify that clinical research professionals must be adequately trained and experienced before engaging in research with human subjects.
The April 2014 issue of Clinical Researcher introduces a whole new look, feel, and name to ACRP’s peer-reviewed journal, previously known as The Monitor. It includes 10 articles from a diverse collection of passionate and expert authors covering a wide range of topics related to improving trial performance.
Each issue of Clinical Researcher offers 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 focus on specific themes, and these scholarly articles and other informal columns are both solicited and accepted unsolicited from authors globally on topics that target the full range of the Members’ skill levels.
As of 2022, Clinical Researcher is published online six times per year (February, April, June, August, October, and December). Please contact Managing Editor Gary Cramer at email@example.com for details on the Editorial Calendar and how to submit articles for peer review or columns for consideration to appear in an upcoming issue.
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 “Author Guidelines” and “Writing Tips” below, 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, Contact Us.
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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.
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.