The Association of Clinical Research Professionals

Mastering the Basics of Good Clinical Practice

NOTE: This course is NOT available for individual registration.   

Upcoming Courses

This course is available for organizations only.  If you are interested in this course for your organization, please contact us.

This one-day, instructor-led classroom course introduces the learner to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines (ICH E6 GCP). Participants learn the history of the ICH and the importance of the E6 guidelines in conducting clinical trials. Presented in lecture format, the course covers the key aspects of the clinical research process by reviewing each section of the GCP guidelines.

Ensure your interactions with human subjects, including vulnerable populations, adhere to the ethical standards of human subject protection. Gain a thorough understanding of the roles and responsibilities of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), Investigator and Sponsor. Learn the standard elements of a clinical trial protocol, the importance of the investigator brochure, and the need for essential documents and how they vary between investigator and sponsor. Presented in game format, periodic knowledge checks solidify the students’ understanding of topics discussed.

Learning Objectives

By the end of this course, participants will be able to:

  • Describe the purpose and principles of ICH GCP, including ICH, FDA Directives and Good Documentation Practice (GDP).
  • Outline the significant milestones in the history of GCP development.
  • Define the standards for working with human subjects, including vulnerable populations.
  • Describe the roles and responsibilities of IRBs/IECs, investigators, sponsors and monitors in the clinical research process.
  • Review implications of the Clinical Trial Regulation and following guidelines.
  • Differentiate between adverse event, adverse drug reaction and serious adverse event.
  • List at least 10 of the required elements of informed consent.
  • Identify essential documents, including the investigator’s brochure and documents that require IRB/IEC review and approval.
  • Describe the standard elements of a clinical trial protocol.
  • Define key terms used in clinical trials internationally, including Investigator, Sponsor, Monitor, Essential Documents, Informed Consent, Adverse Event and Serious Adverse Event.
  • Discuss some case studies with practical applications of GCP.

Bring this Program to Your Team — Minimize out-of-office time and travel expenses while providing your team with programs that will improve job performance and build competency. This in-person classroom course is ready to deliver at your facility.
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