ISO 14155:2020 - Clinical Investigation Conduct
Course Description:
This course describes the conduct and activities at the beginning and throughout the course of clinical investigations in accordance with ISO 14155.
This course covers the following topics:
- Initiation visits
- Site monitoring
- Adverse event and device deficiency reporting
- Documents, documentation, and data control
- Electronic system requirements
- Auditing requirements
- Training new site personnel
- Guaranteeing subjects’ privacy and confidentiality
- Accounting for all subjects
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Comply with ISO 14155 on the following subjects:
- Site initiation and monitoring
- Adverse events and device deficiencies
- Documents, documentation, and data control
- Requirements of electronic systems
- Auditing requirements
- New site personnel
- Subject privacy and confidentiality
- Accounting of subjects
Who Should Enroll:
Clinical research associates (monitors), clinical study coordinators, assistant senior clinical research associates, clinical project and data managers, data entry personnel, ethics committee and institutional review board members, regulators, and notified body personnel involved in auditing clinical evaluations are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
Knowledge of monitoring medical device clinical investigations is recommended.