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.
We need to take a careful look at how best to evaluate, implement, and re-evaluate technology use at all stages of the trial and patient journey. This will inform a technology strategy to help leverage platforms to work for our site staff rather than against them.
A high-performing quality culture—based on established values, traditions, procedures, and expectations that promote continuous quality improvement—should be a goal for all stakeholders.