01/562226 DC : DRAFT JUNE 2001

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 plans
   6.4 Design of the clinical investigation
   6.5 Confidentiality
   6.6 Start of clinical investigation
   6.7 Informed consent
   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 pre-clinical clinical information
   6.12 Auditing
   6.13 Final report
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 final report
Annex A (informative) - Literature review
A.1 Introduction
A.2 Methodology
Annex B (informative) - Information of the ethics committees
Annex C (informative) - Final report of clinical investigations
                        with medical devices
C.1 General
C.2 Title page
C.3 Summary
C.4 Table of contents
C.5 Introduction
C.6 Materials and methods
C.7 Discussion and overall conclusions:
C.9 Abbreviations and definitions
C.10 Ethics
C.11 Investigators and investigation administrative structure
C.12 Signature blocks
C.13 Annex to the report
Bibliography

BS EN ISO 14155-1