Module 1: GCP history and 13 principles
Module 2: Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – responsibilities, composition, functions and operations, procedures and records
Module 3: Investigator’s qualifications and responsibilities for subject protection and medical care, trial conduct and data handling
Module 4: Sponsor’s responsibilities before, during and after the trial.
Module 5: Monitoring – Planning, Conducting and Documenting
Module 6: Handling of Adverse Events – Identification, Assessment and Reporting of AE
Module 7: Handling of Investigational Medicinal Products (IMP) – How to handle IMP at the sponsor and at the trial site
There are quiz after each module to test your understanding of the training materials.
The quiz includes both questions and interesting case stories from real life.
You will get a clear overview of different activities at the sponsor and at the trial site before, during and after a clinical trial.