ACRP’s Core Competency Framework for Clinical Study Monitoring identifies the core competencies required of individuals involved in clinical study monitoring.
Clinical trial monitoring requires new knowledge, skills, and abilities. If you are responsible for monitoring conduct, interacting with monitors, or if want to become a monitor yourself, you need to prepare today by understanding the core competencies required for monitoring.
Regardless of your role in clinical research, ACRP’s Core Competency Framework for Clinical Study Monitoring can be used to help you understand:
“There is, for me, a need for standardization. We would like CRAs to uniformly accomplish their tasks when they go on monitoring visits. When you’ve got a global organization of maybe 1,500/1,600 CRAs working in about 50 countries, you need the reassurance that everybody is doing basically the same thing every day at each site.”
Industry is seeking new and different ways to conduct clinical studies as complexity increases, costs continue to rise, and success rates decline. At the same time, industry is challenged by a critical shortage of monitors and seems poised to respond by moving toward hiring practices that favor competence over experience requirements. These factors combined have created a need to standardize expectations and performance standards related to monitoring activities.
Expect increased utilization of technology to streamline and accelerate study conduct. Professionals involved with or impacted by monitoring activities should anticipate greater focus on data considered most critical to studies and increase utilization of electronic data, case report form software, “The Internet of Things,” mobile tech, and risk mitigation tools. The future of monitoring will also require significant change in relationships between research partners, particularly the relationships between staff at study sites and sponsors/contract research organizations.