New European Union legislation that requires clinical trial master file data to be kept for 25 years from study completion requires actions from sites – including those based in the United States.
Academic medical centers face multiple hurdles to attracting a well-trained workforce of clinical research professionals (CRPs), with a lack of competency-based job descriptions and standardization across and within institutions. These stand in the way of successful recruitment, onboarding and retention.
In a recent three-year period, more than 40% of active principal investigators in the United States conducted just one industry-sponsored pharmaceutical clinical trial, the authors of a forthcoming article for ACRP’s Clinical Researcher journal report.