For the novice research professional, the clinical research field can seem both daunting and confusing. This TRIUM Training provides the high-level knowledge required for a proper understanding of the research related rules, responsibilities, interactions and jargon used. An introduction to research history and definitions, ethics, guidelines (ICH GCP – ISO14155) and regulations, clinical research in pharma, biotech and medical devices, trial roles and responsibilities will be provided in an interactive fashion.
For both the junior and experienced research professional, this is the ideal training to refresh and update your ICH GCP R2 and ISO 14155 knowledge and certification.
Next to case studies and opportunities for discussion, various exercises will ensure learning retention and practical applications.
At the end, you will receive a certificate and handy hand-outs for later use.
By the end of this TRIUM Training you should be able to:
- Define clinical trials
- Describe the therapy development process
- List the most important guidelines and regulations on a global scale for clinical trials
- List the various research stakeholders and how they interact
- Explain the main sponsor, investigator and ethics committee responsibilities as per ICH GCP (R2) and ISO14155
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.