EN ISO 14155:2011

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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
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.
See MEDDEV 2.7/1, Section 6.3.
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
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.

SAE = Serious Adverse Event.
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
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.
See MEDDEV 2.7/1, Section 6.3.
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.
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.
SAE = Serious Adverse Event.
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
ISO 14155:2011(E)
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ii © ISO 2011 – All rights reserved

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 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

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.
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 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 rights, safety and well-being of human subjects,
⎯ ensure the scientific conduct of the 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, regulatory 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 whether 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 latest edition of the referenced
document (including any amendments) applies.
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 14155:2011(E)
3 Terms and definitions
For the purposes of this document, the following terms and 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 malfunction 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 abnormal
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 involved.
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 recorded, 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)
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 to assess the safety or performance of a
medical device
NOTE “Clinical trial” or “clinical study” are synonymous with “clinical investigation”.
2 © ISO 2011 – All rights reserved

ISO 14155:2011(E)
3.7
clinical investigation plan
CIP
document that state(s) the rationale, objectives, design and proposed analysis, methodology, monitoring,
conduct and record-keeping of the clinical investigation
NOTE The term “protocol” is synonymous with “CIP”. However, protocol has many different meanings, some not
related to clinical investigation, and these can differ from country to country. Therefore, the term CIP is used in this
International Standard.
3.8
clinical investigation report
document describing the design, execution, statistical analysis and results of a clinical investigation
3.9
clinical performance
behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended
use, when correctly applied to appropriate subject(s)
3.10
comparator
medical device, therapy (e.g. active control), placebo or no treatment, used in the reference group in a clinical
investigation
3.11
contract research organization
CRO
person or organization contracted by the sponsor to perform one or more of the sponsor's clinical
investigation-related duties and functions
3.12
coordinating investigator
investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation
3.13
data monitoring committee
DMC
independent committee that may be established by the sponsor to assess, at intervals, the progress of the
clinical investigation, the safety data or the critical performance endpoints and to recommend the sponsor
whether to continue, suspend, modify, or stop the clinical investigation
NOTE Examples of DMCs are “data safety monitoring board (DSMB)” or “data safety monitoring committee (DSMC)”.
3.14
deviation
instance(s) of failure to follow, intentionally or unintentionally, the requirements of the CIP
3.15
device deficiency
inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance
NOTE Device deficiencies include malfunctions, use errors, and inadequate labelling.
3.16
endpoint(s)
〈primary〉 principal indicator(s) used for assessing the primary hypothesis of a clinical investigation
3.17
endpoint(s)
〈secondary〉 indicator(s) used for assessing the secondary hypotheses of a clinical investigation
ISO 14155:2011(E)
3.18
ethics committee
EC
independent body whose responsibility it is to review clinical investigations in order to protect the rights, safety
and well-being of human subjects participating in a clinical investigation
NOTE For the purposes of this International Standard, “ethics committee” is synonymous with “research ethics
committee”, “independent ethics committee” or “institutional review board”. The regulatory requirements pertaining to
ethics committees or similar institutions vary by country or region.
3.19
hypothesis
testable statement, resulting from the objective, regarding the investigational medical device safety or
performance that is used to design the clinical investigation and that can be accepted or rejected based on
results of the clinical investigation and statistical calculations
NOTE The primary hypothesis is the determinant of the investigational medical device safety or performance
parameters and is usually used to calculate the sample size. Secondary hypotheses concerning other points of interest
can also be evaluated.
3.20
independent
not involved in the conduct of a clinical investigation, except for their specifically assigned responsibilities, in
order to avoid bias or a conflict of interest
3.21
informed consent process
process by which an individual is provided information and is asked to voluntarily participate in a clinical
investigation
NOTE Informed consent is documented by means of a written, signed and dated informed consent form.
3.22
investigation site
institution or site where the clinical investigation is carried out
NOTE For the purpose of this International Standard, “investigation site” is synonymous with “investigation centre”.
3.23
investigational medical device
medical device being assessed for safety or performance in a clinical investigation
NOTE 1 This includes medical devices already on the market, that are being evaluated for new intended uses, new
populations, new materials or design changes.
NOTE 2 In this International Standard, the terms “investigational medical device” and “investigational device” are used
interchangeably.
3.24
investigator
individual member of the investigation site team designated and supervised by the principal investigator at an
investigation site to perform critical clinical-investigation-related procedures or to make important clinical-
investigation-related decisions
NOTE An individual member of the investigation site team can also be called “sub-investigator” or
“co-investigator”.
4 © ISO 2011 – All rights reserved

ISO 14155:2011(E)
3.25
investigator's brochure
IB
compilation of the current clinical and non-clinical information on the investigational medical device(s),
relevant to the clinical investigation
3.26
legally authorized representative
individual or judicial or other body authorized under applicable law to consent, on behalf of a prospective
subject, to the subject's participation in the clinical investigation
3.27
malfunction
failure of an investigational medical device to perform in accordance with its intended purpose when used in
accordance with the instructions for use or CIP
3.28
medical device
any instrument, apparatus, implement, machine, appliance, implant, software, material, or other similar or
related article
a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of
the specific purpose(s) of
1) diagnosis, prevention, monitoring, treatment or alleviation of disease,
2) diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
3) investigation, replacement, modification, or support of the anatomy or of a physiological process,
4) supporting or sustaining life,
5) control of conception,
6) disinfection of medical devices, and
b) which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its intended function by such means
NOTE The term “medical device” is usually defined by national regulations. For the purposes of this International
[1]
Standard, this definition does not list “in vitro diagnostic medical devices” (see ISO 13485:2003, definition 3.7 ).
3.29
monitoring
act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded, and
reported in accordance with the CIP, written procedures, this International Standard, and the applicable
regulatory requirements
3.30
multicentre investigation
clinical investigation that is conducted according to a single CIP and takes place at two or more investigation
sites
3.31
objective
main purpose for conducting the clinical investigation
ISO 14155:2011(E)
3.32
point of enrolment
time at which, following recruitment, a subject signs and dates the informed consent form
3.33
principal investigator
qualified person responsible for conducting the clinical investigation at an investigation site
NOTE 1 If a clinical investigation is conducted by a team of individuals at an investigation site, the principal investigator
is responsible for leading the team.
NOTE 2 Whether this is the responsibility of an individual or an institution can depend on national regulations.
3.34
randomization
process of assigning subjects to the investigational medical device or comparator groups using an established
recognized statistical methodology to determine the assignment in order to reduce bias
3.35
recruitment
active efforts to identify subjects who may be suitable for enrolment into the clinical investigation
3.36
serious adverse device effect
SADE
adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event
3.37
serious adverse event
SAE
adverse event that
a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body function, or
3) in-patient or prolonged hospitalization, or
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment
to a body structure or a body function,
c) led to foetal distress, foetal death or a congenital abnormality or birth defect
NOTE Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without serious
deterioration in health, is not considered a serious adverse event.
3.38
source data
all information in original records, certified copies of original records of clinical findings, observations, or other
activities in a clinical investigation, necessary for the reconstruction and evaluation of the clinical investigation
3.39
source document
printed, optical or electronic document containing source data
EXAMPLES Hospital records, laboratory notes, device accountability records, photographic negatives, radiographs,
records kept at the investigation site, at the laboratories and at the medico-technical departments involved in the clinical
investigation.
6 © ISO 2011 – All rights reserved

ISO 14155:2011(E)
3.40
sponsor
individual or organization taking responsibility and liability for the initiation or implementation of a clinical
investigation
NOTE When an investigator initiates, implements and takes full responsibility for the clinical investigation, the
investigator also assumes the role of the sponsor and is identified as the sponsor-investigator.
3.41
subject
individual who participates in a clinical investigation
NOTE A subject can be either a healthy volunteer or a patient.
3.42
unanticipated serious adverse device effect
USADE
serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the
current version of the risk analysis report
NOTE Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or
outcome has been identified in the risk analysis report.
3.43
use error
act or omission of an act that results in a different medical device response than intended by the manufacturer
or expected by the user
NOTE 1 Use error includes slips, lapses, and mistakes.
NOTE 2 An unexpected physiological response of the subject d
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