NEN 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 pre-clinical 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

Specifies procedures for the conduct and performance of clinical investigations of medical devices. It also defines 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.