This module provides practical information to help professionals initiate safe, effective, and compliant clinical trials. It addresses the following components as they relate to clinical trials: select FDA forms, key elements of informed consent, the Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Board (IRB), important meetings, and study files. To enhance learning and illustrate the material covered, a fictitious yet realistic clinical trial study will be discussed throughout the module.

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 2 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.