I.S. EN ISO 14155:2020
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Hardcopy , PDF
12-14-2020
English
09-07-2020
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.
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
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