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NEN EN ISO 14155-2 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: CLINICAL INVESTIGATION PLANS
01-02-2011
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Clinical Investigation Plan (CIP)
4.3 General information
4.3.1 Identification of the clinical investigation
plan
4.3.2 Clinical investigators, principal clinical
investigator, co-ordinating clinical investigator,
investigation centres/site(s)
4.3.3 Sponsor
4.3.4 Monitoring arrangements
4.3.5 Data and quality management
4.3.6 An overall synopsis of the clinical investigation
4.3.7 Approval and agreement to the clinical
investigation plan
4.4 Identification and description of the medical device
to be investigated
4.5 Preliminary investigations and justification of the
study
4.5.1 Literature review
4.5.2 Preclinical testing
4.5.3 Previous clinical experience
4.5.4 Device risk analysis and risk assessment
4.6 Objectives of the clinical investigation
4.7 Design of the clinical investigation
4.8 Statistical considerations
4.9 Deviations from the clinical investigation plan
4.10 Amendments to the clinical investigation plan
4.11 Adverse events and adverse device effects
4.12 Early termination or suspension of the investigation
4.13 Publication policy
4.14 Case Report Forms
Annex A (informative) Case Report Forms
Bibliography
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