The updated ISO 14155 guideline published in 2020 provides guidance and requirements on how clinical trials should be conducted.
This 3-hour course will focus on the impact of the new ISO 14155:2020 on clinical investigations and our daily work in clinical research. Emphasis lies on the roles and responsibilities, how this version differs from the previous one and from GCP E6 R2, and how it relates to the MDR.
At the end, attendees will receive a certificate and the course hand-outs (in PDF format).
By the end of this TRIUM Training you should be able to:
- Identify the main changes from the 2011 ISO 14155 version
- Explain the sponsor, IEC and investigator responsibilities per ISO 14155:2020
- Explain the differences and similarities between ICH GCP E6 R2,MDR and ISO 14155:2020
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.