The Association of Clinical Research Professionals

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

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 training program.

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

This 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.

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

  • 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

This course helps clinical researchers of all types build competency in Data Management and Informatics, Medicines Development and Regulation, and Scientific Concepts and Research Design. Explore Competencies >

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