The Association of Clinical Research Professionals

The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials


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

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. The International Conference on Harmonization’s (ICH) E8 guidance document General Considerations for Clinical Trials is put to practice in this interactive eLearning course.

Upon completion of this course, you will understand the drug development process, and the similarities and differences between various study designs, study objectives and phases of development.

This eLearning course is excellent for those newer to the field of clinical research who need an awareness of the drug development process and how their work fits into the grand scheme. It also benefits those who are preparing for an ACRP Certification exam who need to brush up on their knowledge and application of ICH E8.

Learning Objectives

  • Discuss the general principles for the conduct of research
  • Assess issues and considerations for development plans
  • Evaluate issues and considerations for an individual clinical trial

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 >>


All clinical research professionals.