AAMI ISO 14155-1 : 2003

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 10993-1:2003
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Justification for a clinical investigation
5 Ethical considerations
   5.1 Declaration of Helsinki
   5.2 Improper influence or inducement
   5.3 Compensation and additional health care
   5.4 Responsibilities
6 General requirements
   6.1 Formal agreement(s)
   6.2 Qualifications
   6.3 Clinical investigation plan
   6.4 Design of the clinical investigation
   6.5 Confidentiality
   6.6 Start of clinical investigation
   6.7 Informed consent
        6.7.1 General
        6.7.2 Process of obtaining informed consent
        6.7.3 Information to be provided to the subject for
              the purpose of obtaining informed consent
        6.7.4 Informed consent statement
        6.7.5 Informed consent agreement
   6.8 Suspension or early termination of the clinical
        investigation
   6.9 Document and data control
   6.10 Accounting for subjects
   6.11 Access to preclinical and clinical information
   6.12 Auditing
7 Documentation
   7.1 General
   7.2 Clinical investigator's brochure
   7.3 Other documents
8 Sponsor
   8.1 General
   8.2 Responsibilities of sponsor
9 Monitor
   9.1 Responsibilities of monitor
10 Clinical investigator
   10.1 General
   10.2 Qualification of clinical investigator
   10.3 Responsibilities of clinical investigator
11 Final report
   11.1 Presentation of results
   11.2 Contents of the final report
Annexes
A - Suggested procedure for literature review
B - Information for the ethics committees
C - Final reports of clinical investigations with medical
    devices
Bibliography

Describes procedures for the conduct and performance of clinical investigations of medical devices.