I.S. EN ISO 14155:2020&LC:2020
Current
The latest, up-to-date edition.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Hardcopy , PDF
English
08-12-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of good clinical practice (GCP) principles
5 Ethical considerations
6 Clinical investigation planning
7 Clinical investigation conduct
8 Suspension, termination, and close-out of the clinical investigation
9 Responsibilities of the sponsor
10 Responsibilities of the principal investigator
Annex A (normative) Clinical investigation plan (CIP)
Annex B (normative) Investigator's brochure (IB)
Annex C (informative) Case report forms (CRFs)
Annex D (normative) Clinical investigation report
Annex E (informative) Essential clinical investigation documents
Annex F (informative) Adverse event categorization
Annex G (informative) EC responsibilities
Annex H (informative) Application of ISO 14971 to clinical investigations
Annex I (informative) Clinical development stages
Annex J (informative) Clinical investigation audits
Bibliography
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
| Committee |
TC 194
|
| DocumentType |
Standard
|
| Pages |
106
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 14155:2020 | Identical |
| EN ISO 14155:2020 | Identical |
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