AAMI 14155 2011
$140.32
ANSI/AAMI/ISO 14155:2011 – Clinical investigation of medical devices for human subjects.
| Published By | Publication Date | Number of Pages |
| AAMI | 2011 | 74 |
Addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects – Good clinical practice |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 11 | Background of ANSI/AAMI adoption of ISO 14155:2011 |
| 12 | Foreword |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 20 | 4 Ethical considerations 4.1 General 4.2 Improper influence or inducement 4.3 Compensation and additional health care 4.4 Responsibilities |
| 21 | 4.5 Communication with the ethics committee (EC) 4.5.1 General 4.5.2 Initial EC submission 4.5.3 Information to be obtained from the EC 4.5.4 Continuing communication with the EC |
| 22 | 4.5.5 Continuing information to be obtained from the EC 4.6 Vulnerable populations 4.7 Informed consent 4.7.1 General |
| 23 | 4.7.2 Process of obtaining informed consent 4.7.3 Special circumstances for informed consent 4.7.3.1 General 4.7.3.2 Subject needing legally authorized representatives 4.7.3.3 Subject unable to read or write |
| 24 | 4.7.3.4 Emergency treatments 4.7.4 Information to be provided to the subject |
| 26 | 4.7.5 Informed consent signature |
| 27 | 4.7.6 New information 5 Clinical investigation planning 5.1 General 5.2 Risk evaluation 5.3 Justification for the design of the clinical investigation |
| 28 | 5.4 Clinical investigation plan (CIP) 5.5 Investigator’s brochure (IB) 5.6 Case report forms (CRFs) 5.7 Monitoring plan 5.8 Investigation site selection 5.9 Agreement(s) |
| 29 | 5.10 Labeling 5.11 Data monitoring committee (DMC) 6 Clinical investigation conduct 6.1 General 6.2 Investigation site initiation 6.3 Investigation site monitoring |
| 30 | 6.4 Adverse events and device deficiencies 6.4.1 Adverse events 6.4.2 Device deficiencies 6.5 Clinical investigation documents and documentation 6.5.1 Amendments 6.5.2 Subject identification log 6.5.3 Source documents |
| 31 | 6.6 Additional members of the investigation site team 6.7 Subject privacy and confidentiality of data 6.8 Document and data control 6.8.1 Traceability of documents and data 6.8.2 Recording of data |
| 32 | 6.8.3 Electronic clinical data systems 6.9 Investigational device accountability |
| 33 | 6.10 Accounting for subjects 6.11 Auditing 7 Suspension, termination and close-out of the clinical investigation 7.1 Suspension or premature termination of the clinical investigation 7.1.1 Procedure for suspension or premature termination |
| 34 | 7.1.2 Procedure for resuming the clinical investigation after temporary suspension |
| 35 | 7.2 Routine close-out 7.3 Clinical investigation report |
| 36 | 7.4 Document retention 8 Responsibilities of the sponsor 8.1 Clinical quality assurance and quality control |
| 37 | 8.2 Clinical investigation planning and conduct 8.2.1 Selection of clinical personnel |
| 38 | 8.2.2 Preparation of documents and materials 8.2.3 Conduct of clinical investigation |
| 39 | 8.2.4 Monitoring 8.2.4.1 General 8.2.4.2 Qualifications of the monitor 8.2.4.3 Assessment of the investigation site 8.2.4.4 Initiation of the investigation site |
| 40 | 8.2.4.5 Routine on-site monitoring visits |
| 41 | 8.2.4.6 Close-out activities 8.2.4.7 Monitoring reports 8.2.5 Safety evaluation and reporting |
| 42 | 8.2.6 Clinical investigation close-out 8.3 Outsourcing of duties and functions |
| 43 | 8.4 Communication with regulatory authorities 9 Responsibilities of the principal investigator 9.1 General 9.2 Qualification of the principal investigator 9.3 Qualification of investigation site |
| 44 | 9.4 Communication with the EC 9.5 Informed consent process 9.6 Compliance with the CIP |
| 45 | 9.7 Medical care of subjects |
| 46 | 9.8 Safety reporting |
| 47 | Annex A Clinical investigation plan (CIP) A.1 General |
| 48 | A.2 Identification and description of the investigational device A.3 Justification for the design of the clinical investigation |
| 49 | A.4 Risks and benefits of the investigational device and clinical investigation A.5 Objectives and hypotheses of the clinical investigation A.6 Design of the clinical investigation |
| 51 | A.7 Statistical considerations A.8 Data management A.9 Amendments to the CIP |
| 52 | A.10 Deviations from clinical investigation plan A.11 Device accountability A.12 Statements of compliance A.13 Informed consent process A.14 Adverse events, adverse device effects and device deficiencies |
| 53 | A.15 Vulnerable population A.16 Suspension or premature termination of the clinical investigation A.17 Publication policy A.18 Bibliography |
| 54 | Annex B Investigator’s brochure (IB) B.1 General B.2 Investigational device information |
| 55 | B.3 Preclinical testing B.4 Existing clinical data B.5 Risk management B.6 Regulatory and other references |
| 56 | Annex C Case report forms (CRFs) C.1 General C.2 Content and format |
| 57 | C.3 Procedural issues |
| 58 | Annex D Clinical investigation report D.1 General D.2 Cover page D.3 Table of contents |
| 59 | D.4 Summary D.5 Introduction D.6 Investigational device and methods |
| 60 | D.7 Results |
| 61 | D.8 Discussion and overall conclusions D.9 Abbreviated terms and definitions |
| 62 | D.10 Ethics D.11 Investigators and administrative structure of clinical investigation D.12 Signature page D.13 Annexes to the report |
| 64 | Annex E Essential clinical investigation documents |
| 71 | Annex F Adverse event categorization |
| 74 | Bibliography |
