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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
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Available format(s): Hardcopy, PDF
Withdrawn date: 28-02-2021
Language(s): English
Published date: 01-01-2011
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.
Foreword1 Scope2 Normative references3 Terms and definitions4 Ethical considerations5 Clinical investigation planning6 Clinical investigation conduct7 Suspension, termination and close-out of the clinical investigation8 Responsibilities of the sponsor9 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 categorizationBibliographyAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical DevicesAnnex ZB (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices
Specifies 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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