DIN EN ISO 14155-2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155 2011 + Cor 1 2011) German version EN ISO 14155 2011 + AC 2011.pdf

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1、January 2012 Translation by DIN-Sprachendienst.English price group 24No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 11.100.20!$y,n“1860975www.din.deDDIN EN ISO 14155Clinical investigation of medical devices for human subjects Good clinical practice (ISO 14155:2011 + Cor. 1:2011)English translation of DIN EN ISO 14155:2012-01Klinische Prfung von Medizinprodukten an Menschen Gute klinische Praxis (ISO 14155:2011

3、+ Cor. 1:2011)Englische bersetzung von DIN EN ISO 14155:2012-01Investigation clinique des dispositifs mdicaux pour sujets humains Bonnes pratiques cliniques (ISO 14155:2011 + Cor. 1:2011)Traduction anglaise de DIN EN ISO 14155:2012-01SupersedesDIN EN ISO 14155-1:2009-11andDIN EN ISO 14155-2:2009-11w

4、ww.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.6801.12 DIN EN ISO 14155:2012-01 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of

5、medical devices” in collaboration with Technical Committee CEN/TC 258 “Clinical investigation of medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee),

6、Working Committee NA 027-02-20 AA Klinische Prfungen. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 14971 DIN EN ISO 14971 Amendments This standard differs from DIN EN ISO 14155-1:2009-11 and DIN EN ISO 14155-2:2009-11 as follows: a) the

7、 content of the former Part 2 specifying the clinical investigation plan (CIP) has been incorporated; b) Clause 3 “Terms and definitions” has been updated; c) the national regulations relating to the clinical investigation of medicinal products have been taken into account, where appropriate; d) the

8、 duties/roles of sponsor, monitor and investigator have been specified in separate clauses; e) the investigators brochure (IB) has been transferred to Annex B (normative); f) informative Annex E with Tables E.1, E.2 and E.3 relating to the essential clinical investigation documents has been included

9、; g) informative Annex F “Adverse event categorization” has been included. Previous editions DIN EN 540: 1993-07 DIN EN 540 Berichtigung 1: 1998-08 DIN EN ISO 14155-1: 2003-09, 2009-11 DIN EN ISO 14155-2: 2003-09, 2009-11 National Annex NA (informative) Bibliography DIN EN ISO 14971, Medical devices

10、 Application of risk management to medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14155 October 2011 + AC July 2011 ICS 11.100.20 Supersedes EN ISO 14155:2011.English version Clinical investigation of medical devices for human subjects Good clinical practice (ISO 14155:2011

11、 + Cor. 1:2011) Investigation clinique des dispositifs mdicaux pour sujets humains Bonnes pratiques cliniques (ISO 14155:2011 + Cor. 1:2011) Klinische Prfung von Medizinprodukten an Menschen Gute klinische Praxis (ISO 14155:2011 + Cor. 1:2011) EN ISO 14155:2006 was approved by CEN on 2011-09-20 and

12、Corrigendum AC:2011 on 2011-07-15. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nati

13、onal standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. The European Standard exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own languag

14、e and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia

15、, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels

16、2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14155:2011 + AC:2011 EsContents Page Foreword 4 Foreword to EN ISO 14155/AC:2011 .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Ethical considerations . 1

17、1 4.1 General . 11 4.2 Improper influence or inducement 12 4.3 Compensation and additional health care . 12 4.4 Responsibilities 12 4.5 Communication with the ethics committee (EC) . 12 4.5.1 General . 12 4.5.2 Initial EC submission . 12 4.5.3 Information to be obtained from the EC . 13 4.5.4 Contin

18、uing communication with the EC 13 4.5.5 Continuing information to be obtained from the EC . 13 4.6 Vulnerable populations 13 4.7 Informed consent 14 4.7.1 General . 14 4.7.2 Process of obtaining informed consent . 14 4.7.3 Special circumstances for informed consent 14 4.7.4 Information to be provide

19、d to the subject 15 4.7.5 Informed consent signature 17 4.7.6 New information 17 5 Clinical investigation planning 18 5.1 General . 18 5.2 Risk evaluation 18 5.3 Justification for the design of the clinical investigation 18 5.4 Clinical investigation plan (CIP) 18 5.5 Investigators brochure (IB) . 1

20、9 5.6 Case report forms (CRFs) 19 5.7 Monitoring plan . 19 5.8 Investigation site selection 19 5.9 Agreement(s) . 19 5.10 Labelling 19 5.11 Data monitoring committee (DMC) 20 6 Clinical investigation conduct . 20 6.1 General . 20 6.2 Investigation site initiation 20 6.3 Investigation site monitoring

21、 . 20 6.4 Adverse events and device deficiencies 20 6.4.1 Adverse events . 20 6.4.2 Device deficiencies . 20 6.5 Clinical investigation documents and documentation . 21 6.5.1 Amendments . 21 6.5.2 Subject identification log . 21 6.5.3 Source documents 21 6.6 Additional members of the investigation s

22、ite team 21 6.7 Subject privacy and confidentiality of data . 21 6.8 Document and data control . 22 2 DIN EN ISO 14155:2012-01 EN ISO 14155:2011 + AC:2011 (E) 6.8.1 Traceability of documents and data 22 6.8.2 Recording of data 22 6.8.3 Electronic clinical data systems 22 6.9 Investigational device a

23、ccountability 23 6.10 Accounting for subjects . 23 6.11 Auditing 23 7 Suspension, termination and close-out of the clinical investigation 24 7.1 Suspension or premature termination of the clinical investigation . 24 7.1.1 Procedure for suspension or premature termination 24 7.1.2 Procedure for resum

24、ing the clinical investigation after temporary suspension 25 7.2 Routine close-out 25 7.3 Clinical investigation report . 25 7.4 Document retention . 26 8 Responsibilities of the sponsor . 26 8.1 Clinical quality assurance and quality control . 26 8.2 Clinical investigation planning and conduct 27 8

25、.2.1 Selection of clinical personnel . 27 8.2.2 Preparation of documents and materials 27 8.2.3 Conduct of clinical investigation . 28 8.2.4 Monitoring 28 8.2.5 Safety evaluation and reporting . 31 8.2.6 Clinical investigation close-out . 31 8.3 Outsourcing of duties and functions 32 8.4 Communicati

26、on with regulatory authorities . 32 9 Responsibilities of the principal investigator 32 9.1 General . 32 9.2 Qualification of the principal investigator 32 9.3 Qualification of investigation site 33 9.4 Communication with the EC . 33 9.5 Informed consent process . 33 9.6 Compliance with the CIP. 33

27、9.7 Medical care of subjects . 34 9.8 Safety reporting . 35 Annex A (normative) Clinical investigation plan (CIP) 36 Annex B (normative) Investigators brochure (IB) . 43 Annex C (informative) Case report forms (CRFs) 45 Annex D (informative) Clinical investigation report 47 Annex E (informative) Ess

28、ential clinical investigation documents . 52 Annex F (informative) Adverse event categorization 59 Bibliography 62 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices . 63 Annex ZB (informative) Relationship b

29、etween this European Standard and the Essential Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices 65 3 DIN EN ISO 14155:2012-01 EN ISO 14155:2011 + AC:2011 (E) Foreword This document (EN ISO 14155:2011) has been prepared by Technical Committee ISO/TC 194 “Biological evalu

30、ation of medical devices” in collaboration with Technical Committee CEN/TC 258 “Clinical investigation of medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, a

31、t the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or

32、 all such patent rights. This document supersedes EN ISO 14155:2011. This new edition contains revised Annexes ZA and ZB. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directi

33、ve(s). For relationship with EU Directives, see informative Annexes ZA and ZB, which are an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgi

34、um, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsemen

35、t notice The text of ISO 14155:2011 has been approved by CEN as EN ISO 14155:2011 without any modification. Foreword to EN ISO 14155 /AC:2011 This document (EN ISO 14155:2011/AC:2011) has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices” in collaboration with

36、 Technical Committee CEN/TC 258 “Clinical investigation of medical devices” the secretariat of which is held by DIN. Endorsement notice The text of ISO 14155:2011/Cor. 1:2011 has been approved by CEN as EN ISO 14155:2011/AC:2011 without any modification. 4 DIN EN ISO 14155:2012-01 EN ISO 14155:2011

37、+ AC:2011 (E) 1 Scope This International Standard addresses 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. The principles set forth in thi

38、s International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard specifies general requirements intended to protect the ri

39、ghts, safety and well-being of human subjects, ensure the scientific conduct of th e clinical investigation and the credibility of the clinical investigation results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, r egula

40、tory authorities and other bodies involved in the conformity assessment of medical devices. It does not apply to in vitro diagnostic medical devices. NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider wheth

41、er other standards and/or requirements also apply to the investigational device(s) under consideration. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the

42、latest edition of the referenced document (including any amendments) applies. ISO 14971:2007, Medical devices Application of risk management to medical devices 5 DIN EN ISO 14155:2012-01 EN ISO 14155:2011 + AC:2011 (E) 3 Terms and definitions For the purposes of this document, the following terms an

43、d definitions apply. 3.1 adverse device effect ADE adverse event related to the use of an investigational medical device NOTE 1 This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunc

44、tion of the investigational medical device. NOTE 2 This definition includes any event resulting from use error or from intentional misuse of the investigational medical device. 3.2 adverse event AE any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including a

45、bnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device NOTE 1 This definition includes events related to the investigational medical device or the comparator. NOTE 2 This definition includes events related to the procedures invo

46、lved. NOTE 3 For users or other persons, this definition is restricted to events related to investigational medical devices. 3.3 audit systematic independent examination of activities and documents related to clinical investigation to determine whether these activities were conducted, and the data r

47、ecorded, analysed and accurately reported, according to the CIP, standard operating procedures, this International Standard and applicable regulatory requirements 3.4 blinding/masking procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s)

48、 NOTE Single blinding usually refers to the subject(s) being unaware of the treatment assignment(s). Double blinding usually refers to the subject(s), investigator(s), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s). 3.5 case report forms CRFs set of printed, optical or electronic documents for each subject on which information to be reported to the sponsor is recorded, as required by the CIP 3.6 clinical investigation systematic investigation in one or more human subjects, undertaken t