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Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
:
Available format(s): Hardcopy, PDF
Superseded date: 17-09-2020
Language(s): English
Published date: 31-10-2011
Publisher: National Standards Authority of Ireland
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.
Foreword 1 Scope2 Normative references3 Terms and definitions 4 Ethical considerations 5 Clinical investigation planning 6 Clinical investigation conduct 7 Suspension, termination and close-out of the clinical investigation8 Responsibilities of the sponsor 9 Responsibilities of the principal investigatorAnnex 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 reportAnnex E (informative) Essential clinical investigation documentsAnnex F (informative) Adverse event categorization Bibliography
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
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