概要
The module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial.
The Clinical Trials Fundamentals eLearning Program is divided into three modules:
- Clinical Trials: Study Preparation
- Clinical Trials: Study Initiation
- Clinical Trials: Conducting the Study
As learners make decisions during the clinical trial, the program explains how each scenario relates to the regulations, guidelines, and practices for conducting clinical trials.
This ICH E6 R2 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.