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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 […]

Applying Lean Methodology to Improve the Informed Consent Process

Clinical Researcher—November 2018 (Volume 32, Issue 9) PEER REVIEWED Melissa Kadar; Lindsey Sikora, RN   In 1978, the Belmont Report{1} was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published in the Federal Register. This important document outlines three fundamental ethical principles and guidelines for conducting […]

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Webinar: Best of ACRP 2018: Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

November 13, 2018, 12:00-1:00 pm – This session will cover adverse event (AE) reporting for medical device clinical trials, including the following topics: the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on a study protocol, and a discussion on device AE reporting requirements from a monitoring and auditing mindset.


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.


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