EN ISO 14155-2:2009

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
Annex ZA (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
         on Medical Devices
Annex ZB (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 90/385/EEC
         on Active Implantable Medical Devices

1 ScopeThis part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.This Standard does not apply to in vitro diagnostic medical devices.