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FDA Commissioner Scott Gottlieb, MD

FDA Updates Expanded Access Program

In a renewed effort to advance clinical trial options for medical products for patients with serious or immediately life-threatening diseases, the U.S. Food and Drug Administration (FDA) announced last week it will begin implementing suggestions it has received to enhance its Expanded Access program. Sometimes called “compassionate use,” Expanded Access is a pathway through which […]

Develop a Comprehensive Learning Needs Assessment for Your Research Staff

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Tracy Graham, RN, BSN, CCRC   Targeted continuing education for research staff is an important component of any research program. Continuing education that is meaningful to research staff promotes professional development and improves the quality of research. The foundation of a successful continuing education plan is […]

The Necessity of Clinical Research Documentation Training Programs and the Value of Learning from Mistakes

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Paula Smailes, DNP, RN, CCRP, CCRC   Source documentation lies at the heart of clinical research workflows for investigative sites.  Adequate documentation of protocol-related visits ensures that required information on study conduct and results has been captured for sponsors and other stakeholders.{1} In the clinical research […]

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Webinar: Best of ACRP 2018: FDA Inspections: Understand the Process and Respond Effectively

November 14, 2018, 12:00-1:00 pm – Do you understand the process, forms and expectations following an FDA Inspection? We will review the documents exchanged during an inspection and the process followed by FDA to determine whether a warning letter will be issued.


Webinar: Best of ACRP 2018: Oops, I Did It Again-How to Write a (Simple) and Effective CAPA Plan

November 28, 2018, 12:00-1:00 pm – Learn the basics of what makes a corrective and preventative action (CAPA) plan.


Webinar: Writing for Publication in the Clinical Research Field

December 5, 2018, 12:00 pm-1:00pm – This session will overview writing for clinical research journals and is designed to empower clinical research professionals to contribute to the evidence and best practices within the industry.


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