The Association of Clinical Research Professionals

Key Skills for Ensuring Quality Control through Risk-Based Decision Making

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives.

PLEASE NOTE: This course content is currently under review. It will be available in early 2024 although you may still enroll now.

Quality control initiatives used to ensure subject safety and data integrity are maintained throughout clinical trials. But finite resources, such as time and personnel, must be deployed carefully and appropriately.

Risk-based decision making is a method of ensuring quality control initiatives are rolled out appropriately, according to the levels of posed risks.

Course content covers key aspects related to risks in clinical trials, including:

  • Identification
  • Analysis
  • Categorization
  • Management
  • Planning
  • Assessment
  • Communication
  • Change management

Upon completion of this training program, participants should be able to:

  • Explain the need for quality control, trial management and change management to ensure quality, risk-based decision making
  • Describe how  the clinical researcher’s job focus and responsibilities change in the context of risk-based monitoring
  • Describe how to make quality, risk-based decisions that ensure patient safety, data quality and regulatory compliance

This course helps clinical research professionals of all types build competency in Leadership and Professionalism and Study and Site Management. Explore Competencies >

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date