The recent revisions of ISO 14155: 2011 Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice have been well received as a global standard for medical device GCP. This training course focuses on the ISO standard’s sections specific to investigator responsibilities. The content of this training can be used as a foundation for investigator training for study responsibilities.
At the conclusion of this 90-minute session, participants will be able to:
- Training on ISO 14155: 2011 to principal investigators and others that manage investigative sites on studies that recognize the standard
- Study team members with an overview of the requirements of the standard, plusany significant differences between local requirements and the standard
- Information to facilitate a gap analysis and implementation plan to adapt the standard into current practice