《BS-EN-ISO-14155-2-2003.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-14155-2-2003.pdf（18页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans The European Standard EN ISO 14155-2:2003 has the status of a British Standard ICS 11.040.01 ? BS EN ISO 14155-2:2003 This British Standard was published under th
2、e authority of the Standards Policy and Strategy Committee on 27 May 2003 BSI 27 May 2003 ISBN 0 580 41910 X National foreword This British Standard is the official English language version of EN ISO 14155-2:2003. It is identical with ISO 14155-2:2003. The UK participation in its preparation was ent
3、rusted to Technical Committee CH/194, Biological Evaluation of Medical Devices, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publica
4、tions referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the neces
5、sary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the inter
6、pretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, pages 2 to 14, an inside back cover and
7、 a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14155-2 May 2003 ICS 11.040.01 English version Clinical investigation of me
8、dical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003) Investigation clinique des dispositifs mdicaux sur les sujets humains - Partie 2: Plan dinvestigation clinique (ISO 14155-2:2003) Klinische Prfung von Medizinprodukten an Menschen - Teil 2: Klinische Prfplne (
9、ISO 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 b
10、ibliographical 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
11、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,
12、 Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by a
13、ny means reserved worldwide for CEN national Members. Ref. No. EN ISO 14155-2:2003 E EN ISO 14155-2:2003 (E) 2 Contents page Foreword3 Introduction.4 1Scope 5 2Normative references 5 3Terms and definitions5 4Requirements.6 4.1General6 4.2Clinical Investigation Plan (CIP).6 4.3General information.6 4
14、.3.1Identification of the clinical investigation plan.6 4.3.2Clinical investigators, principal clinical investigator, co-ordinating clinical investigator, investigation centres/site(s) .6 4.3.3Sponsor.6 4.3.4Monitoring arrangements6 4.3.5Data and quality management6 4.3.6An overall synopsis of the c
15、linical investigation7 4.3.7Approval and agreement to the clinical investigation plan.7 4.4Identification and description of the medical device to be investigated .7 4.5Preliminary investigations and justification of the study7 4.5.1Literature review 7 4.5.2Preclinical testing 7 4.5.3Previous clinic
16、al experience.8 4.5.4Device risk analysis and risk assessment8 4.6Objectives of the clinical investigation .8 4.7Design of the clinical investigation8 4.8Statistical considerations .9 4.9Deviations from the clinical investigation plan 10 4.10Amendments to the clinical investigation plan 10 4.11Adver
17、se events and adverse device effects .10 4.12Early termination or suspension of the investigation10 4.13Publication policy 10 4.14Case Report Forms11 Annex A (informative) Case Report Forms.12 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisi
18、ons of EU Directives13 Bibliography14 EN ISO 14155-2:2003 (E) 3 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 1
19、94 “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.
20、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
21、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, Luxembour
22、g, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. EN ISO 14155-2:2003 (E) 4 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 st
23、andard. 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
24、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. EN ISO 14155-2:2003 (E) 5 1Scope This part of EN ISO 14155 provides requir
25、ements 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
26、 a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices. 2Normative 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
27、 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 (in
28、cluding amendments). EN ISO 14155-1:2003, Clinical investigation of medical devices for human subjects Part 1: General requirements. (ISO 14155-1:2001) 3Terms 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
29、.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 enrolm
30、ent 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 d
31、evice are observed 3.5 recruitment process of identifying subjects who may be suitable for enrolment into the clinical investigation EN ISO 14155-2:2003 (E) 6 4Requirements 4.1General All requirements of EN ISO 14155-1 apply. 4.2Clinical Investigation Plan (CIP) The CIP shall be a document developed
32、 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 sha
33、ll include the information specified in the subsequent clauses. Alternatively, if the required information is written in other documentation, for example the clinical investigators brochure or the sponsors standard operating procedures, such documentation shall be referenced in the CIP and shall be
34、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 4.3.1Identification
35、 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 r
36、eferenced with the version number. 4.3.2Clinical 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
37、 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 ad
38、dress(es) of other establishments or persons involved in patient management, and associated testing and analysis shall be given. 4.3.3Sponsor The CIP shall state the name and address of the sponsor of the clinical investigation. NOTEIf the sponsor is not resident in the country (countries) in which
39、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. 4.3.4Monitoring arrangements The CIP shall state the monitoring arrangements to be followed during the investigat
40、ion and the planned extent of source data verification. 4.3.5Data 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. EN
41、ISO 14155-2:2003 (E) 7 4.3.6An overall synopsis of the clinical investigation The CIP shall provide a summary or overview of the clinical investigation. NOTEIt 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
42、 the conduct of the investigation. 4.3.7Approval 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 b
43、y signing and dating an appropriate document. 4.4Identification 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
44、 the device, its model or type number including software version and accessories, if any, to permit full identification and traceability. If this information is not known at the time the CIP is written, a description shall be given as to how traceability shall be achieved during and after the study;
45、 b) the intended purpose of the device as stated by the manufacturer including the clinical indications and contra- indications for use in the proposed study and the populations for which it is intended; c) a description of the device including any materials that will be in contact with tissues or b
46、ody fluids. This shall include details of any medicinal products, human and/or animal tissues or their derivatives, or other biologically active substances; d) instructions for installation and use of the device including any necessary storage and handling requirements, preparation for use and any i
47、ntended re-use (e.g. sterilization), any pre-use checks of safety and performance and any precautions to be taken after use, e.g. disposal; e) a summary of necessary training and experience needed for the use of the device under investigation; f) a description of the necessary medical or surgical pr
48、ocedures involved in the use of the device. 4.5Preliminary investigations and justification of the study 4.5.1Literature review The CIP shall contain a critical review of the relevant scientific literature and/or unpublished data and reports together with a list of the literature reviewed. The concl
49、usions from this review shall justify the design of the proposed investigation. The review shall be relevant to the intended purpose of the device to be investigated and the proposed method of use. It should also help in the identification of relevant end-points and confounding factors that should be considered, and the choice and justification of control methods. NOTEGuidance on literature review and appraisal is provided in EN ISO 14155 1:2003, annex A. 4.5.2Preclinical testing Th