ISO 14155:2020 - Scope

This course covers the background of the ISO 14155 standard and how it applies in conjunction with international regulatory documents. It outlines the scope of the ISO 14155 and how it’s requirements apply to the different types of medical clinical investigations.

The course provides a summary of GCP principles as outlined in the standard and provides a list of documents referenced in the standard.

This course also explores other mandatory standards needed to conduct clinical investigations such as ISO 14971.