Description
Designing and conducting a clinical trial should be done with Good
Clinical Practice (GCP) and quality in mind to ensure the reliability
of trial results as well as to follow requirements of regulatory
authorities. Organizations usually understand the necessity of
following ICH E6(R2) to ensure GCP; however, there is frequently
a gap in training internal teams, contractors, CROs, and sites on
ISO 14155:2020 GCP for medical devices. Following the standard
is a key part of building globally recognized GCP into the full life
cycle of the medical device clinical trial and can complement the
current GCP training.
This course covers an overview of the ISO 14155:2020 standard for medical device GCP. Use with a copy of your organization’s standard or purchase a copy from www.iso.org.
Content includes an Overview of the Standard, Clinical Investigation Planning, Sponsor Responsibilities, Responsibilities of the Investigator, Clinical Investigation Conduct, and Suspension, Termination, and Close-out of Clinical Investigation.
