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

h-0

dition

◎ISO 2026

ISO 14155:2026(en)

@ISO 2026

be reproduced or utilized otherwise in any form or by any means,electronic or mechanical,including photocopying,or posting on

the internet or an intranet,without prior written permission.Permission can be requested from either ISO at the address below

or ISO's member body in the country of the requester.

ISO copyright office

CP401·Ch.de Blandonnet 8

CH-1214 Vernier,Geneva

Phone:+41227490111

Email:copyright@iso.org

Website: www.iso.org

Published in Switzerland

iii

ISO 14155:2026(en)

Contents Page

Foreword ......................................................................................................................................................................................vi

Introduction ..........................................................................................................................................................................ii

1 Scope ............................................................................................................................................................................... 1

2 Normative references ...................................................................................................................................................

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

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标签： #ISO #2026 #GCP

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ReferencenumberClinicalinvestigationofmedicaldevicesforhumansubjects—GoodclinicalpracticeInvestigationcliniquedesdispositifsmédicauxpoursujetshumains—BonnepratiquecliniqueISO14155:2026(en)InternationalStandardISO14155F2ou02h-0e3dition◎ISO2026iiISO14155:2026(en)COPYRIGHTPROTECTEDDOCUMENT@ISO2026Allri...

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