> iso_14155:2020
ISO 14155:2020
Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice (GCP)
ISO 14155:2020 establishes principles of Good Clinical Practice (GCP) specifically for medical device and software investigations in human subjects. It aligns with the Declaration of Helsinki, specifying requirements for trial protocol design, institutional review board (IRB) approvals, informed consent, clinical data integrity, electronic data capture (EDC), and adverse event reporting.
Scope & Applicability
Applies to clinical investigations conducted to assess the clinical performance, effectiveness, or safety of medical devices in human subjects.
Non-Coverage Boundaries
Does not replace pharmaceutical drug trial GCP guidelines (which are governed by ICH E6(R3)).
Key Clauses & Control Requirements
Clinical Investigation Plan (CIP)
Detailed protocol defining endpoints, statistical methodology, inclusion/exclusion criteria, and monitoring procedures.
Electronic Data Handling & Integrity
Validation of electronic clinical trial systems, immutable audit trails, and strict ALCOA+ data integrity enforcement.
Required Regulatory & Audit Evidence Artifacts
- [✓]Clinical Investigation Plan (CIP) and Investigator's Brochure (IB)
- [✓]Ethics Committee / IRB Approval Letters and Signed Informed Consent Forms
- [✓]Trial Master File (TMF) and Clinical Data Management System Validation Records
“Clinical trial endpoints generated by your software are what get pharmaceutical therapies and devices approved. A single data corruption flaw can invalidate a multimillion-dollar study.”
Cross-Surface Ecosystem Relationships
- ISO 14155:2020 Clinical investigation of medical devices ↗(International Organization for Standardization)
Frequently Asked Questions
How does ISO 14155 relate to ICH E6 GCP?
ICH E6 is designed primarily for medicinal products (drugs), whereas ISO 14155 addresses the unique lifecycle and investigational challenges of medical devices.