The Association of Clinical Research Professionals

White Papers & Reports

ACRP works with its members and stakeholders to publish white papers, reports, and comment letters that reflect our mission to promote excellence in clinical research.

WORKFORCE DEVELOPMENT

This paper sets out a vision of how to integrate a constellation of solutions into a coherent, holistic framework, comprising a blueprint for collaborative effort (March 2025)

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Barriers to Bridges White Paper Cover

This ACRP white paper explores the growing workforce shortage in clinical research, its root causes, and disruptive ways to turn barriers into bridges (September 2022)

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Now is the Time to Fix the Clinical Research Workforce Crisis

Stephanie A Freel, Denise C. Snyder, Kara Bastarache, Carolynn T. Jones, Mark B. Marchant, Laura A. Rowley, Stephen A. Sonstein, Karen M. Lipworth, and Susan P. Landis; Journal of the Society for Clinical Trials, June 2, 2023, Sage Journals, DOI: 10.1177/17407745231177885. Read Online >  Read PDF >

“Join the team” clinical research workforce development model: A new paradigm in healthcare career opportunities

Kate Marusina, Olga Kishchenko, and Angela Griffiths; Journal of Clinical and Translational Science, Volume 8, Issue 1, 2024, e128 DOI: doi.org/10.1017/cts.2024.577. Read Online > Read PDF >

Building the Clinical Research Workforce: Challenges, Capacities and Competencies

Carolynn T. Jones, Elizabeth Johnson, Barbara E. Bierer, Denise C. Snyder, Hazel Ann Smith, Emma Akuffo, and Stephen Sonstein; Frontiers in Pharmacology, July 16, 2024, Frontiers Publishing. Read Online >

 

DCTs

This tool can help site teams plan DCT trial budgets. Understanding potential budget pitfalls—and planning to avoid them—is critical for success. Lean on the collective expertise of professionals who have been there, done that, and offered to share. (December 2023)

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This paper examines work by ACRP to build awareness of the need for a new budget model for sites and to leverage the adoption of decentralized clinical trial elements to improve how sites are supported in their critical contribution to drug development. (December 2023)

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This special report documents perspectives on the realities of implementing decentralized approaches at sites. The data comes from a critical survey compiling responses from 291 clinical researchers employed in a broad range of roles. (November 2022)

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DCT White Paper Cover

Authored by members of ACRP’s Fellows Advisory Panel, this white paper assesses the significant implications of how decentralized clinical trials leverage technologies to interact remotely with trial participants. Key recommendations are noted. (March 2022)

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SPECIAL REPORTS

Across every industry, the adoption of AI is increasing rapidly. This white paper was written to assist the clinical research community in understanding the application and implications of artificial intelligence in a rapidly evolving landscape. (January 2025)

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COVID 19 White Paper Cover

This white paper spotlights the impact of COVID-19 on clinical research professionals at both an organizational and human level, examining their challenges, insights, successes, and the personal price many had to pay in the interest of their vocation. (April 2022)

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ADVOCACY EFFORTS

ACRP Advocates for Clinical Researcher Occupation Code: ACRP’s PACRW Consortium requested the establishment of a new occupation code for the role of Clinical Researcher under the 29-0000 Healthcare Practitioners and Technical Occupations code when the U.S. Bureau of Labor Statistics announced a review of the 2018 Standard Occupational Classification Manual for possible revision in 2028. (August 2024)

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ACRP’s Response to FDA Draft Guidance on Diversity in Clinical Trials: The ACRP Diversity Advisory Council was published in Update, the quarterly magazine of the Food and Drug Law Institute (FDLI). DAC members—who have extensive day-to-day experience on the realities of running clinical trials—provided their viewpoints on the pathways forward for sites and sponsors. Shared with the permission of FDLI. (Spring 2023)

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ACRP’s Response to FDA Draft Guidance on Ethical Considerations Involving Children: The Association of Clinical Research Professionals (ACRP) submitted the following comments on behalf of the membership to the Food and Drug Administration’s (FDA) Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Guidance for Industry, Sponsors, and IRBs. (December 2022)

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STAKEHOLDER PERSPECTIVES

David Burrow, PharmD, JD, U.S. Food and Drug Administration, speaks to the importance of investing in the clinical research workforce staff.

 

Mo Ali, Astellas Pharmaceuticals, and Susan Landis, ACRP, discuss how industry partnerships can benefit the clinical research workforce.