UNI 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
  4.4 Identification and description of the medical device
       to be investigated
  4.5 Preliminary investigations and justification of the
       study
  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
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
Bibliography

Supplies 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.