After having received your first ICH GCP E6 and/or ISO 14155 training, it is a custom in the research field to repeat this training on a frequent basis to ensure compliance and to avoid QA findings and the unwanted related subject safety/well-being and data quality’ issues at all times. This TRIUM Training provides the in-depth knowledge and skills required for a proper understanding and application of the ICH GCP E6 R2 guideline- and ISO 14155 standard principles in the research field. Each section for both ICH GCP E6 R2 and ISO 14155 will be covered in theory, followed by interactive discussions, sharing of real life case studies and exercises showing how the requirements and responsibilities of the roles described (sponsor, investigator, IEC/IRB e.g.) intertwine. The provided gap analysis between ICH GCP E6 R2 and ISO 14155 helps researcher who work or both drug/bio- and device studies or on combination products to know the difference and to ensure quality for both.
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 certificate. This training is certified by Transcelerate.
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:
- Describe the ICH GCP E6 R2 and ISO 14155 principles
- Explain the responsibilities of the investigator, sponsor and Ethics Committee for ICH GCP E6 R2 and ISO 14155
- List the purpose and content of a trial protocol/clinical investigation plan and the Investigator Brochure (IB)
- Describe the purpose and the requirements related to essential documents for the conduct of a clinical trial
- Apply what you learned to your daily research practice to ensure subject well-being and data quality
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.