This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.
All clinical researcher professionals receive extensive training on Good Clinical Practice and other processes to be followed in their work. A topic that is only superficially covered is why those processes are required.
Assessing the capacity of a clinical research coordinator (CRC) is one of many challenges involved in managing clinical trials—which are heterogeneous and increasingly complex, with rising regulatory burdens and tight budgets.
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.