The Association of Clinical Research Professionals

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

Pricing With Contact Hours

Member: $22.50 | Nonmember: $149

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This course is approved for 1.5 ACRP contact hours. Accreditation Details

This eLearning course will be accessible for up to one year from the date of purchase.

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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This eLearning course will be accessible for up to one year from the date of purchase.

Course Description

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.

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. Course content covers key aspects related to risks in clinical trials, including:

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

Learning Objectives

  • 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

Competency Domains

This course builds competence in the following domains:

  • Leadership and Professionalism
  • Study and Site Management

Learn About Competency Domains for Clinical Research Professionals >>


All clinical research professionals