I.S. EN ISO 14155:2011&LC:2011-11
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Hardcopy , PDF
17-09-2020
English
31-10-2011
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 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical investigation
8 Responsibilities of the sponsor
9 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 (informative) Clinical investigation report
Annex E (informative) Essential clinical investigation documents
Annex F (informative) Adverse event categorization
Bibliography
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