ISO 14155-2026 Clinical investigation of medicaldevices for human subjects - Goodclinical practice
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Reference number
Clinical investigation of medical
devices for human subjects —Good
clinical practice
Investigation clinique des dispositifs médicaux pour sujets
humains—Bonne pratique clinique
ISO 14155:2026(en)
International
Standard
ISO 14155
F
2
ou
02
h-0
e
3
dition
◎ISO 2026
ii
ISO 14155:2026(en)
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Published in Switzerland
CISO 2026-All rights reserved
iii
ISO 14155:2026(en)
Contents Page
Foreword ......................................................................................................................................................................................vi
Introduction ..........................................................................................................................................................................ii
1 Scope ............................................................................................................................................................................... 1
2 Normative references ...................................................................................................................................................
1
3 Terms and definitions ............................................................................................................................................... 1
4 Summary of good clinical practice principles .................................................................................................. 9
5 Ethical considerations ........................................................................................................................................... 10
5.1 Genera ..............................................................................................................................................................10
5.2 Improper influence or inducement ........................................................................................................... 10
5.3 Compensation and additional health care ............................................................................................. 10
5.4 Registration in publicly accessible database ...........................................................................................11
5.5 Responsibilities ............................................................................................................................................... 1
5.6 Communication with the ethics committe .......................................................................................... 11
5.6.1 General ...............................................................................................................................................11
5.6.2 Initial ECsubmission ....................................................................................................................... 11
5.6.3 Information to be obtained from the EC ..................................................................................... 12
5.6.4 Continuing communication with the EC ..................................................................................... 12
5.6.5 Continuing information to be obtained from the EC ............................................................... 12
5.7 Vulnerable populations ............................................................................................................................... 12
5.8 Informed consent ........................................................................................................................................... 13
5.8.1 General ...............................................................................................................................................13
5.8.2 Process of obtaining informed consent .....................................................................................13
5.8.3 Special circumstances for informed consent ........................................................................... 14
5.8.4 Information to be provided to the subjec .................................................................................15
5.8.5 Informed consent signature ......................................................................................................... 16
5.8.6 New information ............................................................................................................................... 17
6Clinical investigation planning ........................................................................................................................... 17
6.1 Genera ..............................................................................................................................................................17
6.2 Risk management ......................................................................................................................................... 17
6.2.1 General ............................................................................................................................................... 17
6.2.2 Risks related to the use of the investigational device and their disclosure ................... 18
6.2.3 Risks related to clinical procedures required by the CIP outside routine clinical
practice .............................................................................................................................................. 18
6.2.4 Risks related to the clinical investigation proces ...................................................................19
6.3 Justification for the design of the clinical investigation ....................................................................... 19
6.4 Clinical investigation plan........................................................................................................................... 19
6.5 Investigator ' s brochure ............................................................................................................................... 20
6.6 Case report form ............................................................................................................................................ 20
6.7 Monitoring plan ............................................................................................................................................... 20
6.8 Investigation site selection ....................................................................................................................... 21
6.9 Agreement (s .....................................................................................................................................................2
6.10 Labelling ........................................................................................................................................................... 2
6.11 Data monitoring committe .......................................................................................................................2
6.12 Clinical events committe ........................................................................................................................... 22
7Clinical investigation conduc ............................................................................................................................... 23
7.1 Genera ..............................................................................................................................................................23
7.2 Investigation site initiation .......................................................................................................................... 23
7.3 Investigation site monitoring ...................................................................................................................... 23
7.4 Adverse events and device deficiencies ..................................................................................................23
7.4.1 Signals requiring immediate action ............................................................................................. 23
7.4.2 Adverse events ............................................................................................................................... 23
7.4.3 Device deficiencies ......................................................................................................................... 24
CISO 2026-All rights reserved
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ReferencenumberClinicalinvestigationofmedicaldevicesforhumansubjects—GoodclinicalpracticeInvestigationcliniquedesdispositifsmédicauxpoursujetshumains—BonnepratiquecliniqueISO14155:2026(en)InternationalStandardISO14155F2ou02h-0e3dition◎ISO2026iiISO14155:2026(en)COPYRIGHTPROTECTEDDOCUMENT@ISO2026Allri...
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作者：安心365
分类：法规规范
价格：120质量币
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时间：2026-04-15
