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PIs Struggle With ‘One and Done’ Phenomenon

Principal investigators (PIs) who dip one toe into conducting clinical trials with dreams of easy, new money streams are often in for a rude awakening. Studies have demonstrated a large—and growing—percentage of PIs join the so-called “One and Done” club, whose members are PIs who get involved in a trial, find the experience overwhelming, and […]

FDA Unveils Real-World Evidence Program Framework

Just in time for the holidays, the U.S. Food and Drug Administration (FDA) has giftwrapped and delivered the framework it plans to use to implement its Real-World Evidence (RWE) Program. FDA defines RWE as the “clinical evidence about the usage and potential benefits or risks of a medical produce derived from analysis of” real-world data […]

FDA Shows No Letup with New Biomarker Guidance

Traditionally, the workplace pace slows as the holiday spirit overtakes us in December. Days are a little less productive. Employees take vacations. It’s a time usually reserved for office parties and long lunches. Tell that to the U.S. Food and Drug Administration (FDA). Yesterday (December 12), the agency released another clinical trial–related guidance—this one providing […]

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ACRP 2019

April 12-15, 2019 in Nashville—ACRP 2019 brings the clinical research community together to learn, connect, and explore opportunities to drive excellence in clinical research. ACRP 2019 is the ideal venue for learning the practical strategies, best practices, and creative solutions needed to improve clinical trial operations. Back by popular demand—earn 24 ACRP contact hours!


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