EN ISO 14155-2:2003
(Main)Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
Klinische Prüfung von Medizinprodukten an Menschen - Teil 2: Klinische Prüfpläne (ISO 14155-2:2003)
Dieser Teil von EN ISO 14155 legt Anforderungen für die Erarbeitung von Prüfplänen (CIP) für die klinische Prüfung von Medizinprodukten fest. Die Erarbeitung eines CIP in Übereinstimmung mit den Anforderungen dieser Norm und dessen Befolgung wird die wissenschaftliche Gültigkeit einer klinischen Prüfung und die Reproduzierbarkeit ihrer Ergebnisse verbessern helfen.
Diese Norm gilt nicht für Medizinprodukte für die in vitro Diagnostik.
Investigation clinique des dispositifs médicaux sur les sujets humains - Partie 2: Plan d'investigation clinique (ISO 14155-2:2003)
La présente partie de l'EN ISO 14155 spécifie des exigences relatives à la préparation d'un plan d'investigation clinique (PIC) pour l'investigation clinique de dispositifs médicaux. Un plan d'investigation clinique, élaboré en accord avec les exigences de la présente norme et le respect de ses dispositions, permettra d'aider à optimiser la validité scientifique et la reproductibilité des résultats d'une investigation clinique.
La présente norme n'est pas applicable aux dispositifs médicaux de diagnostic in vitro.
Klinične raziskave medicinskih pripomočkov za ljudi – 2. del: Načrti kliničnih raziskav (ISO 14155-2:2003)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14155-2:2003
01-september-2003
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Clinical investigation of medical devices for human subjects - Part 2: Clinical
investigation plans (ISO 14155-2:2003)
Klinische Prüfung von Medizinprodukten an Menschen - Teil 2: Klinische Prüfpläne (ISO
14155-2:2003)
Investigation clinique des dispositifs médicaux sur les sujets humains - Partie 2: Plan
d'investigation clinique (ISO 14155-2:2003)
Ta slovenski standard je istoveten z: EN ISO 14155-2:2003
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 14155-2:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 14155-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2003
ICS 11.040.01
English version
Clinical investigation of medical devices for human subjects -
Part 2: Clinical investigation plans (ISO 14155-2:2003)
Investigation clinique des dispositifs médicaux sur les Klinische Prüfung von Medizinprodukten an Menschen -
sujets humains - Partie 2: Plan d'investigation clinique (ISO Teil 2: Klinische Prüfpläne (ISO 14155-2:2003)
14155-2:2003)
This European Standard was approved by CEN on 7 February 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14155-2:2003 E
worldwide for CEN national Members.
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EN ISO 14155-2:2003 (E)
Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions.5
4 Requirements .6
4.1 General.6
4.2 Clinical Investigation Plan (CIP).6
4.3 General information.6
4.3.1 Identification of the clinical investigation plan.6
4.3.2 Clinical investigators, principal clinical investigator, co-ordinating clinical investigator,
investigation centres/site(s) .6
4.3.3 Sponsor.6
4.3.4 Monitoring arrangements.6
4.3.5 Data and quality management.6
4.3.6 An overall synopsis of the clinical investigation.7
4.3.7 Approval and agreement to the clinical investigation plan.7
4.4 Identification and description of the medical device to be investigated .7
4.5 Preliminary investigations and justification of the study.7
4.5.1 Literature review .7
4.5.2 Preclinical testing .7
4.5.3 Previous clinical experience.8
4.5.4 Device risk analysis and risk assessment .8
4.6 Objectives of the clinical investigation .8
4.7 Design of the clinical investigation.8
4.8 Statistical considerations .9
4.9 Deviations from the clinical investigation plan .10
4.10 Amendments to the clinical investigation plan .10
4.11 Adverse events and adverse device effects .10
4.12 Early termination or suspension of the investigation.10
4.13 Publication policy .10
4.14 Case Report Forms.11
Annex A (informative) Case Report Forms .12
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives .13
Bibliography .14
2
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EN ISO 14155-2:2003 (E)
Foreword
This document (EN ISO 14155-2:2003) has been prepared by Technical Committee CEN /TC 258 "Clinical
investigation of medical devices", the secretariat of which is held by AFNOR, in collaboration with Technical
Committee ISO/TC 194 "Biological evaluation of medical devices".
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 November 2003, and conflicting national standards shall be withdrawn at the latest
by November 2003.
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 Directive(s), see informative annex ZA, which is an integral part of this document.
Annex A is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
3
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EN ISO 14155-2:2003 (E)
Introduction
This standard is the second part of EN ISO 14155 "Clinical investigation of medical devices for human subjects",
and should be read in conjunction with that standard.
The standard is intended to assist manufacturers, sponsors, monitors and clinical investigators in the design and
conduct of clinical investigations. It is also intended to assist regulatory bodies and ethics committees in their roles
of reviewing Clinical Investigation Plans (CIP). The CIP is a framework within which appropriate experience, insight,
judgement, qualification and education need to be applied. The scientific rigour of a CIP can be verified and
possibly improved by an independent review of the CIP.
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EN ISO 14155-2:2003 (E)
1 Scope
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the
clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this
standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a
clinical investigation.
This Standard does not apply to in vitro diagnostic medical devices.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These normative
references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references,
subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in
it by amendment or revision. For undated references the latest edition of the publication referred to applies (including
amendments).
EN ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General
requirements. (ISO 14155-1:2001)
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions given in EN ISO 14155-1:2003 and the
following apply.
3.1
end point - primary
principal indicator measured or determined to assess the primary objective of a clinical investigation
3.2
end point - secondary
indicator measured or determined in addition to the primary end-point to assess some other objective of a clinical
investigation
3.3
point of enrolment
time at which, following recruitment, a subject has signed the informed consent form and is regarded as part of the
study population
3.4
follow-up period
period of the clinical investigation after the application of the device under investigation in each subject during
which the effects of the device are observed
3.5
recruitment
process of identifying subjects who may be suitable for enrolment into the clinical investigation
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EN ISO 14155-2:2003 (E)
4 Requirements
4.1 General
All requirements of EN ISO 14155-1 apply.
4.2 Clinical Investigation Plan (CIP)
The CIP shall be a document developed by the sponsor and the clinical investigator(s). The CIP shall be designed
in such a way as to optimise the scientific validity and reproducibility of the results of the study in accordance with
current clinical knowledge and practice so as to fulfil the objectives of the investigation.
The CIP shall include the information specified in the subsequent clauses. Alternatively, if the required information
is written in other documentation, for example the clinical investigator’s brochure or the sponsor’s standard
operating procedures, such documentation shall be referenced in the CIP and shall be made available on request.
In the event of the sponsor deciding that any requirement given in 4.3 to 4.10 is not applicable, relevant or
appropriate, a clear statement justifying the omission of the information specified shall be provided on each
occasion.
4.3 General information
4.3.1 Identification of the clinical investigation plan
The CIP and any amended version shall state the title of the clinical investigation and its reference number. The
CIP shall also include a version/issue number and date to ensure that it may be traced to the signatories (see
4.3.7). Each page of the CIP shall be referenced with the version number.
4.3.2 Clinical investigators, principal clinical investigator, co-ordinating clinical investigator, investigation
centres/site(s)
The CIP shall state or refer to a list of the name(s), address(es), and professional position(s) of the clinical
investigator(s), of the principal clinical investigator(s) and co-ordinating clinical investigator if appointed. The CIP
shall document the name(s) and address(es) of the Institution(s) in which the clinical investigation will be
conducted. Where it may affect the validity of the clinical investigation, the name(s) and address(es) of other
establishments or persons involved in patient management, and associated testing and analysis shall be given.
4.3.3 Sponsor
The CIP shall state the name and address of the sponsor of the clinical investigation.
NOTE If the sponsor is not resident in the country (countries) in which the clinical investigation is to be carried out, the
name and address of a representative in that country (those countries) may be required according to national or regional
regulations.
4.3.4 Monitoring arrangements
The CIP shall state the monitoring arrangements to be followed during the investigation and the planned extent of
source data verification.
4.3.5 Data and quality management
The CIP shall describe or refer to the procedures for database management, treatment of data, source data
verification, data archiving, retention period and other aspects of quality assurance as appropriate.
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EN ISO 14155-2:2003 (E)
4.3.6 An overall synopsis of the clinical investigation
The CIP shall provide a summary or overview of the clinical investigation.
NOTE It may be useful to include a flow chart showing the key stages of the clinical investigation or any other information
that may be of value for the conduct of the investigation.
4.3.7 Approval and agreement to the clinical investigation plan
The sponsor, the co-ordinating investigator (if appointed) and the principal clinical investigator(s) in each centre
shall agree to the CIP and any amendments and indicate their approval and agreement by signing and dating an
appropriate document.
4.4 Identification and description of the medical device to be investigated
The CIP shall include or refer to a summary description of the device to be investigated and its intended purpose.
The following information shall be given:
a) the manufacturer of the device, its model or type number including software version and accessories, if any, to
permit full identification and trace
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