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.