Get trained and certified at your convenience.
- PharmaGCP’s basic GCP online training/course is cost-effective with high quality – easy to understand and interactive.
- The training materials in pdf format contain all essential topis of Good Clinical Practice (GCP).
- The quiz includes both questions and interesting case stories from clinical trials in practice.
- You will get a clear overview of different activities at the sponsor and at the trial site before, during and after a clinical trial.
- The training includes some of the aspects from the updated ICH GCP E6 (R2) 2016 (~ GCP addendum) as relevant for basic level.
- This basic GCP course is relevant for all roles within the conduct of clinical trials, for example trial manager, monitor, clinical trial associate, data manager, statistician, medical writer, safety adviser, regulatory, clinical trial supply manager.
The training consists of 7 modules. There are quiz after each module to test your understanding of the training materials. There is explanation when your answer is wrong.
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
In order to get the basic GCP certificate, you need to pass the examination. See further details below.
*TransCelerate is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world.