The Association of Clinical Research Professionals

Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety

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Member: $189 | Non-Member: $239

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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.


Course Description

Efficiently identify and report safety events in your clinical trials.

Subject safety is top priority in clinical research. As such, safety reporting is the duty of all clinical research professionals, both at the site and sponsor/CRO levels.

Appropriate for all clinical research professionals, this course guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

Make sure you understand why events are reported and their impact on overall subject and patient safety.

This course is ideal for any of the following situations:

  • Introduction to or refresher on roles, responsibilities, definitions and timelines as they relate to safety reporting
  • A component of a corrective and preventive action plan following an audit or inspection
  • Preparation for an ACRP Certification exam

Learning Objectives

  • Define and describe clinical safety terminology
  • Report safety concerns to stakeholders via the correct form and per ICH E2a Section III Standards for Expedited Reporting, and include the appropriate Key Data Elements according to Appendix I
  • Apply the guidelines for specific cases, as defined under Miscellaneous issues (Section III E)
  • Explain when a sponsor should amend the Investigator Brochure

Competency Domains

This course builds competence in the following domains:

  • Data Management and Informatics
  • Medicines Development and Regulation
  • Scientific Concepts and Research Design

Learn About Competency Domains for Clinical Research Professionals >>

Audience

All clinical research professionals.