INTERACTIVE DEMO AVAILABLE BELOW

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.

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.

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.

Course Length: 45 minutes

INCLUDES:

• Unlimited access to the content for 45 days from your initial day of purchase.

• Certificate of completion

• Case Studies

• Post-Assessment

• Knowledge Checks

LEARNING OBJECTIVES

1. Describe the ISO 14155:2020 standard requirements for Medical Device GCP.

2. Recognize how the ISO 14155:2020 standard applies to activities related to site monitoring and investigator responsibilities.

3. Apply the ISO 14155:2020 standard to study activities.

AUDIENCE

All clinical research personnel

INTERACTIVE DEMO: