Foreword
1 Scope
2 Terms and definitions
3 Ethical considerations
3.1 General
3.2 Improper influence or inducement
3.3 Compensation and additional health care
3.4 Responsibilities
3.5 Ethics Committee Procedures
3.5.1 General
3.5.2 Initial EC submission
3.5.3 Continuing EC Oversight
3.5.4 Information to be obtained from the EC
3.6 Vulnerable populations
3.7 Informed consent
3.7.1 General
3.7.2 Process of obtaining informed consent
3.7.3 Special circumstances
3.7.4 Information to be provided to the subject
3.7.5 Informed consent form
3.7.6 New information
4 Investigation planning
4.1 General
4.2 Justification for a clinical investigation
4.3 Risk Assessment
4.4 Clinical investigation plan (CIP)
4.5 Investigator's brochure
4.6 Case report forms (CRFs)
4.7 Formal agreement(s)
4.8 Labeling
4.9 Data-monitoring committee
5 Investigation implementation
5.1 General
5.2 Subject enrollment
5.3 Source documents
5.4 Monitoring
5.5 Adverse events
5.6 Amendments
5.7 Additional Personnel
5.8 Subject privacy and confidentiality of data
5.9 Document and data control
5.9.1 Recording of data
5.9.2 Electronic data systems
5.10 Investigational device accountability
5.11 Accounting for subjects
5.12 Auditing
6 Investigation suspension and close-out
6.1 Suspension or premature termination of the investigation
6.1.1 Reason for suspension or premature termination
6.1.2 Procedure for suspension or premature termination
6.1.3 Procedure for resuming a clinical investigation
after temporary suspension
6.2 Routine close out
6.3 Clinical investigation reports
6.4 Document Retention
7 Responsibilities of sponsor
7.1 Clinical quality assurance and quality control
7.2 Investigation set-up and management
7.2.1 Selection of clinical personnel
7.2.2 Investigation planning
7.2.3 Investigation implementation
7.2.4 Safety evaluation
7.2.5 Investigation close out
7.3 Outsourcing of roles and responsibilities
7.4 Communication with regulatory authorities
8 Responsibilities of the monitor
8.1 General
8.2 Qualifications of the monitor
8.3 Monitoring activities
8.4 Monitoring report
9 Responsibilities of the investigator
9.1 General
9.2 Qualification of investigator
9.3 Qualification of Investigation site
9.4 Communication with the ethics committee
9.5 Informed consent process
9.6 Compliance with the CIP
9.7 Medical care of subjects
9.8 Safety reporting
Annex A (normative) - Clinical Investigation Plan (CIP)
A.1 General
A.1.1 Identification of the clinical investigation
plan
A.1.2 Investigators, principal investigator, co-ordinating
investigator, investigation site(s)
A.1.3 Sponsor
A.1.4 An overall synopsis of the clinical investigation
A.2 Identification and description of the investigational
medical device
A.3 Preliminary investigations and justification of the
investigation
A.3.1 Literature review
A.3.2 Preclinical testing
A.3.3 Previous clinical experience
A.3.4 Device and investigation risk assessment
A.4 Objectives of the clinical investigation
A.5 Design of the clinical investigation
A.5.1 Specifics
A.5.2 Devices and comparators
A.5.3 Subjects
A.5.4 Procedures
A.5.5 Monitoring arrangements
A.6 Statistical considerations
A.7 Data management
A.8 Amendments to the CIP
A.9 Clinical investigation plan deviations
A.10 Device accountability
A.11 Ethics, standards and regulatory
A.12 Informed consent procedure
A.13 Adverse events and adverse device effects
A.14 Vulnerable population
A.15 Early termination or suspension of the investigation
A.16 Publication policy
Annex B (informative) - Case report forms (CRF)
B.1 General
B.2 Content and format
B.2.1 Cover Page
B.2.2 Header or Footer
B.2.3 Types of Forms
B.3 Procedural issues
Annex C (informative) - Clinical investigation report
C.1 General
C.2 Cover page
C.3 Summary
C.4 Table of contents
C.5 Introduction
C.6 Investigational device and methods
C.6.1 Device description
C.6.2 Clinical Investigation Plan
C.7 Results
C.8 Discussion and overall conclusions
C.9 Abbreviated terms and definitions
C.10 Ethics
C.11 Investigators and administrative structure of
investigation
C.12 Signature page
C.13 Annex to the report
Annex D (informative) - Essential clinical investigation
documents
Annex E (informative) - Adverse event reporting
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC on Medical Devices
Bibliography