The Association of Clinical Research Professionals

Core Competency Framework for Clinical Study Monitoring

ACRP’s Core Competency Framework for Clinical Study Monitoring identifies the core competencies required of individuals involved in clinical study monitoring.

PREPARE FOR THE FUTURE OF CLINICAL TRIAL 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.

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Understand the competence requirements for clinical study monitoring across all experience levels in these eight domains:

  • Clinical Trial Operations (GCPs)
  • Communication and Teamwork
  • Data Management and Informatics
  • Ethical and Participant Safety Considerations
  • Leadership and Professionalism
  • Medicines Development and Regulation
  • Scientific Concepts and Research Design
  • Study and Site Management

HOW YOU CAN USE THIS DOCUMENT

Regardless of your role in clinical research, ACRP’s Core Competency Framework for Clinical Study Monitoring can be used to help you understand:

  • What is Changing in Your Role as a Clinical Trial Monitor
  • What is Expected of You in Relation to Monitoring-Related Activities
  • Where to Focus Your Professional Development Activities
  • The Competencies for Which Hiring Managers are Looking
  • What to Look for When Recruiting Staff

Mark Travers, Executive Director of Global Monitoring Excellence, Global Clinical Trial Operation Division, Merck

“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.”

— Mark Travers, Executive Director of Global Monitoring Excellence, Global Clinical Trial Operation Division, Merck

WHAT IS DRIVING CHANGE

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.

WHERE YOU CAN EXPECT CHANGE

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.

“This will support continuous quality improvement and enhance the confidence of patients who depend on medicines from our industry.”

— Doug Schantz, Executive Director, Clinical Trial Operations, AstraZeneca

Doug Schantz, Executive Director, Clinical Trial Operations, AstraZeneca