AAMI ISO 14155-2 : 2003

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14155-2:2003
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, coordinating clinical investigator,
             investigation centers/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
Annexes
A - Case Report Forms
Bibliography

Describes requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices.