AAMI ISO 14155 : 2011

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14155:2011
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical
  investigation
8 Responsibilities of the sponsor
9 Responsibilities of the principal investigator
Annex A (normative) - Clinical investigation plan (CIP)
Annex B (normative) - Investigator's brochure (IB)
Annex C (informative) - Case report forms (CRFs)
Annex D (informative) - Clinical investigation report
Annex E (informative) - Essential clinical investigation
                        documents
Annex F (informative) - Adverse event categorization
Bibliography

Specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.