This module provides practical information to help professionals prepare to conduct safe, effective, and compliant clinical trials. It clarifies the roles and responsibilities of investigators, study teams, and sponsors while unpacking key legislation, regulations, and ethical principles. Learners will explore the phases of clinical trials, essential documents, study design, the use of placebos, and critical site logistics, including evaluation visits, budgets, and contracts. To bring concepts to life, the module uses a fictional but realistic clinical trial example that continues throughout the lessons.

This ICH E6 R3 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

The module takes an average of 3 hours to complete.

This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle.