UNI EN ISO 14155-1 : 2009

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
   6.8 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
Annex A (informative) - Suggested procedure for literature
        review
Annex B (informative) - Information for the ethics committees
Annex C (informative) - Final reports of clinical investigations
        with medical devices 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

Describes procedures for the conduct and performance of clinical investigations of medical devices. Also ascertains general requirements intended to - protect human subjects, - ensure the scientific conduct of the clinical investigation, - assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices.