The Association of Clinical Research Professionals

Core Competency Framework for Clinical Study Monitoring

Prepare for the future of clinical trial monitoring by understanding 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:

  • 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

 

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Background

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.