SIST EN ISO 14155:2012
(Main)Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
ISO 14155:2011 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 ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ISO 14155:2011 does not apply to in vitro diagnostic medical devices.
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011)
Diese Internationale Norm legt die gute klinische Praxis für die Gestaltung, die Durchführung, Aufzeichnung
und Dokumentation klinischer Prüfungen, die an menschlichen Versuchspersonen durchgeführt werden, fest,
um die Sicherheit und Leistungsfähigkeit von Medizinprodukten für regulatorische Zwecke zu bewerten.
Die in der vorliegenden Internationalen Norm dargestellten Grundsätze treffen auf alle anderen klinische
Prüfungen zu und sollten so weit wie möglich, unter Berücksichtigung der Art der klinischen Prüfung und der
Anforderungen der nationalen Bestimmungen, eingehalten werden.
Diese Internationale Norm legt allgemeine Anforderungen fest, mit denen Folgendes erreicht werden soll
⎯ der Schutz der Rechte, Sicherheit und des Wohlergehens der beteiligten Versuchspersonen,
⎯ die Sicherstellung der wissenschaftlich korrekten Durchführung der klinischen Prüfung und der
Glaubwürdigkeit der Ergebnisse der klinischen Prüfung,
⎯ die Festlegung der Verantwortlichkeiten des Sponsors und Prüfungsleiters,
⎯ die Unterstützung der Arbeit von Sponsoren, Prüfern, Ethikkommissionen, gesetzlich Aufsichtsbehörden
und der am Konformitätsbewertungsverfahren für Medizinprodukte beteiligten Institutionen.
Sie gilt nicht für Medizinprodukten für die In vitro Diagnostik.
ANMERKUNG Von ISO/TC 194 erarbeitete Normen sind für die Anwendung auf Medizinprodukte vorgesehen.
Anwender dieser Internationalen Norm haben zu berücksichtigen, ob weitere Normen und/oder Anforderungen auf das zu
betrachtende Prüfprodukt ebenfalls angewendet werden können.
Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques (ISO 14155:2011)
L'ISO 14155:2011 traite les bonnes pratiques cliniques pour la conception, la conduite, l'enregistrement et l'établissement des rapports des investigations cliniques menées sur des sujets humains en vue d'évaluer la sécurité ou les performances des dispositifs médicaux à des fins réglementaires.
Les principes définis dans l'ISO 14155:2011 s'appliquent également aux autres investigations cliniques et il convient de les suivre dans la mesure du possible, en prenant en compte la nature de l'investigation et les exigences imposées par les réglementations nationales.
L'ISO 14155:2011 fixe les exigences générales pour protéger les droits, la sécurité et le bien-être des sujets humains, assurer la conduite scientifique de l'investigation clinique et la crédibilité des résultats de l'investigation, définir les responsabilités du promoteur et de l'investigateur principal et aider les promoteurs, les investigateurs, les comités d'éthique, les autorités réglementaires, et les autres organismes impliqués dans l'évaluation de la conformité des dispositifs médicaux.
L'ISO 14155:2011 ne s'applique pas aux dispositifs médicaux de diagnostic in vitro.
Klinične raziskave medicinskih pripomočkov za ljudi - Dobre klinične prakse (ISO 14155:2011)
ISO 14155:2011 obravnava dobro klinično prakso za načrtovanje, izvajanje, beleženje in poročanje o kliničnih preiskavah, izvedenih na ljudeh, za ocenjevanje varnosti ali delovanja medicinskih pripomočkov za potrebe regulacije.
Načela, določena v ISO 14155:2011, prav tako veljajo za vse preostale klinične raziskave in jim je treba slediti, kolikor je mogoče, glede na naravo kliničnih raziskav in zahteve državnih predpisov.
ISO 14155:2011 določa splošne zahteve za zaščito pravic, varnosti in dobrega počutja ljudi, zagotavlja znanstveno izvajanje klinične preiskave in verodostojnost rezultatov, opredeljuje odgovornost sponzorja in vodilnega raziskovalca ter je opora sponzorjem, preiskovalcem, etičnim odborom, regulativnim organom in drugim organom, ki so vključeni v ugotavljanje skladnosti medicinskih pripomočkov.
ISO 14155:2011 ne velja za diagnostične medicinske pripomočke in vitro.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14155:2012
01-januar-2012
1DGRPHãþD
SIST EN ISO 14155:2011
SIST EN ISO 14155:2011/AC:2011
.OLQLþQHUD]LVNDYHPHGLFLQVNLKSULSRPRþNRY]DOMXGL'REUHNOLQLþQHSUDNVH ,62
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO
14155:2011)
Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO
14155:2011)
Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques
cliniques (ISO 14155:2011)
Ta slovenski standard je istoveten z: EN ISO 14155:2011
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14155:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14155:2012
---------------------- Page: 2 ----------------------
SIST EN ISO 14155:2012
EUROPEAN STANDARD
EN ISO 14155
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 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)
Investigation clinique des dispositifs médicaux pour sujets Klinische Prüfung von Medizinprodukten an Menschen -
humains - Bonnes pratiques cliniques (ISO 14155:2011) Gute klinische Praxis (ISO 14155:2011)
This European Standard was approved by CEN on 20 September 2011.
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 national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists 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 language 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155:2011: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .6
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Foreword
This document (EN ISO 14155:2011) has been prepared by Technical Committee ISO/TC 194 "Biological
evaluation 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, at 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 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 Directive(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, Belgium, 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.
Endorsement notice
The text of ISO 14155:2011 has been approved by CEN as EN ISO 14155:2011 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
For all requirements related to clinical investigations contained in the directive and referred to in the following
chart: Obligations attributed to the "sponsor" under ISO 14155 shall be incumbent, under the MDD to the
manufacturer, if located in the EU/EEA/Turkey/Switzerland, and incumbent to the Authorized Representative
otherwise͘ Both may refer to external service providers in order to fulfil their obligations.
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
Partial fulfilment of the ER, as
regards
1) the documentation of
clinical investigations of
medical devices used in the
Entire standard Annex I. 6a
clinical evaluation process
as referred to in Annex
1
X.1.1 and
2) parts of Annex X.2 listed
below.
ISO 14155 does not refer to a
particular version of the declaration
of Helsinki. The latest available
version of the declaration of Helsinki
must be taken into account.
4.1, 5.2 and 5.3
Annex X:
National/regional requirements for
2.2.
ethics in clinical research and for
protecting the safety, wellbeing,
health and rights of subjects must
be observed.
Annex X:
5,3, 5.4, A.7
2.3.1
Annex X
5.3, A.3 and A.6
2.3.2.
1
See MEDDEV 2.7/1, Section 6.3.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
Annex X:
5.3, A.3 and A.6
2.3.3.
Annex X:
5.3, A.5 and 8.2.5
2.3.4.
Annex X: Partial compliance: covers internal
2.3.5. procedures of sponsor to address
6.4.1, 8.2.5 d) and 9.8
2
SAE -reporting requirements of the
Directive.
Annex X:
5.5, 5.8, 6, 9.2, 9.3 and Annex B
2.3.6.
Annex X:
7.3
2.3.7.
National/regional requirements for
Annex VIII, 2.2., structure/content of ethics in clinical research and for
nd
5.4, Annex A; 5.5, Annex B; 4.7 ,
the documents required in the 2 protecting the safety, wellbeing,
rd th
3 and 5 indent. health and rights of subjects must
be observed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s)/clinical
investigations falling within the scope of this standard.
2
SAE = Serious Adverse Event.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on active
implantable medical devices
For all requirements related to clinical investigations contained in the directive and referred to in the following
chart: Obligations attributed to the "sponsor" under ISO 14155 shall be incumbent, under the MDD to the
manufacturer, if located in the EU/EEA/Turkey/Switzerland, and incumbent to the Authorized Representative
otherwise͘ Both may refer to external service providers in order to fulfil their obligations.
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 90/385/EEC
Partial fulfilment of the ER, as
regards
1) the documentation of
clinical investigations of
medical devices used in the
Entire standard 6a
clinical evaluation process
as referred to in Annex
3
VII.1.1 and
2) parts of Annex VII.2 listed
below.
ISO 14155 does not refer to a
particular version of the declaration
of Helsinki. The latest available
version of the declaration of Helsinki
Annex 7:
must be taken into account.
4.1, 5.2 and 5.3
2.2.
National/regional requirements for
ethics in clinical research and for
protecting the safety, wellbeing,
health and rights of subjects must
be observed.
Annex 7:
5,3, 5.4, A.7
2.3.1.
3
See MEDDEV 2.7/1, Section 6.3.
6
---------------------- Page: 8 ----------------------
SIST EN ISO 14155:2012
EN ISO 14155:2011 (E)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 90/385/EEC
Annex 7:
5.3, A.3 and A.6
2.3.2.
Annex 7:
5.3, A.3 and A.6
2.3.3.
Annex 7:
5.3, A.5 and 8.2.5
2.3.4.
Partial compliance: covers internal
Annex 7:
procedures of sponsor to address
6.4.1, 8.2.5 d) and 9.8
2.3.5.
4
SAE -reporting requirements of the
Directive.
Annex 7:
5.5, 5.8, 6, 9.2, 9.3 and Annex B
2.3.6.
Annex 7:
7.3
2.3.7.
National/regional requirements for
Annex 7, 2.2., structure/content of ethics in clinical research and for
nd
5.4, Annex A; 5.5, Annex B; 4.7 the documents required in the 2 , protecting the safety, wellbeing,
rd th
3 and 5 indent. health and rights of subjects must
be observed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
SAE = Serious Adverse Event.
7
---------------------- Page: 9 ----------------------
SIST EN ISO 14155:2012
---------------------- Page: 10 ----------------------
SIST EN ISO 14155:2012
INTERNATIONAL ISO
STANDARD 14155
Second edition
2011-02-01
Clinical investigation of medical devices
for human subjects — Good clinical
practice
Investigation clinique des dispositifs médicaux pour sujets humains —
Bonnes pratiques cliniques
Reference number
ISO 14155:2011(E)
©
ISO 2011
---------------------- Page: 11 ----------------------
SIST EN ISO 14155:2012
ISO 14155:2011(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2011 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 14155:2012
ISO 14155:2011(E)
Contents Page
Foreword .v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Ethical considerations .7
4.1 General .7
4.2 Improper influence or inducement .8
4.3 Compensation and additional health care.8
4.4 Responsibilities.8
4.5 Communication with the ethics committee (EC).8
4.5.1 General .8
4.5.2 Initial EC submission .8
4.5.3 Information to be obtained from the EC.9
4.5.4 Continuing communication with the EC .9
4.5.5 Continuing information to be obtained from the EC .9
4.6 Vulnerable populations.9
4.7 Informed consent .10
4.7.1 General .10
4.7.2 Process of obtaining informed consent.10
4.7.3 Special circumstances for informed consent .10
4.7.4 Information to be provided to the subject .11
4.7.5 Informed consent signature .13
4.7.6 New information .13
5 Clinical investigation planning .14
5.1 General .14
5.2 Risk evaluation .14
5.3 Justification for the design of the clinical investigation.14
5.4 Clinical investigation plan (CIP).14
5.5 Investigator's brochure (IB).15
5.6 Case report forms (CRFs).15
5.7 Monitoring plan.15
5.8 Investigation site selection .15
5.9 Agreement(s) .15
5.10 Labelling.15
5.11 Data monitoring committee (DMC) .16
6 Clinical investigation conduct .16
6.1 General .16
6.2 Investigation site initiation .16
6.3 Investigation site monitoring .16
6.4 Adverse events and device deficiencies.16
6.4.1 Adverse events.16
6.4.2 Device deficiencies .16
6.5 Clinical investigation documents and documentation.17
6.5.1 Amendments.17
6.5.2 Subject identification log.17
6.5.3 Source documents .17
6.6 Additional members of the investigation site team.17
6.7 Subject privacy and confidentiality of data .17
6.8 Document and data control.18
© ISO 2011 – All rights reserved iii
---------------------- Page: 13 ----------------------
SIST EN ISO 14155:2012
ISO 14155:2011(E)
6.8.1 Traceability of documents and data . 18
6.8.2 Recording of data . 18
6.8.3 Electronic clinical data systems . 18
6.9 Investigational device accountability . 19
6.10 Accounting for subjects. 19
6.11 Auditing . 19
7 Suspension, termination and close-out of the clinical investigation. 20
7.1 Suspension or premature termination of the clinical investigation. 20
7.1.1 Procedure for suspension or premature termination . 20
7.1.2 Procedure for resuming the clinical investigation after temporary suspension . 21
7.2 Routine close-out. 21
7.3 Clinical investigation report . 21
7.4 Document retention. 22
8 Responsibilities of the sponsor . 22
8.1 Clinical quality assurance and quality control . 22
8.2 Clinical investigation planning and conduct . 23
8.2.1 Selection of clinical personnel. 23
8.2.2 Preparation of documents and materials. 23
8.2.3 Conduct of clinical investigation . 24
8.2.4 Monitoring . 24
8.2.5 Safety evaluation and reporting. 27
8.2.6 Clinical investigation close-out. 27
8.3 Outsourcing of duties and functions. 28
8.4 Communication with regulatory authorities . 28
9 Responsibilities of the principal investigator. 28
9.1 General. 28
9.2 Qualification of the principal investigator. 28
9.3 Qualification of investigation site . 29
9.4 Communication with the EC . 29
9.5 Informed consent process. 29
9.6 Compliance with the CIP. 29
9.7 Medical care of subjects . 30
9.8 Safety reporting . 31
Annex A (normative) Clinical investigation plan (CIP). 32
Annex B (normative) Investigator's brochure (IB). 39
Annex C (informative) Case report forms (CRFs) . 41
Annex D (informative) Clinical investigation report. 43
Annex E (informative) Essential clinical investigation documents. 48
Annex F (informative) Adverse event categorization . 55
Bibliography. 58
iv © ISO 2011 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14155:2012
ISO 14155:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14155 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices.
This second edition cancels and replaces the first edition of ISO 14155-1:2003 and the first edition of
ISO 14155-2:2003, which have been technically revised.
© ISO 2011 – All rights reserved v
---------------------- Page: 15 ----------------------
SIST EN ISO 14155:2012
---------------------- Page: 16 ----------------------
SIST EN ISO 14155:2012
INTERNATIONAL STANDARD ISO 14155:2011(E)
Clinical investigation of medical devices for human subjects —
Good clinical practice
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 this Internat
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.