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BS EN ISO 20916:2024

BS EN ISO 20916:2024

$215.11

In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

Published By Publication Date Number of Pages
BSI 2024 76
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This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. NOTE 1 The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to — ensure the conduct of the clinical performance study will lead to reliable and robust study results, — define the responsibilities of the sponsor and principal investigator, — assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and — protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies. Analytical performance studies are out of the scope of this document. NOTE 2 When the collection of specimens specifically for the analytical performance study creates an additional collection risk for subjects, some of the elements of this document (particularly the annexes) can be useful for ensuring subject safety. Clinical performance studies that are performed for reasons other than pre- and post-market regulatory purposes, such as for re-imbursement purposes, are out of the scope of this document. NOTE 3 Some of the elements of this document can be useful for the design of such studies, including subject safety and data integrity. This document does not include safety information for laboratory workers or other personnel collecting the study specimens. NOTE 4 Such information is included in other publications[1][12][13]. NOTE 5 Users of this document can consider whether other standards and/or requirements also apply to the IVD medical device which is the subject of the clinical performance study, for instance, in the situation for which there is an IVD medical device and a medical device used in an integrated system (e.g. a lancet, an IVD test strip, and a glucose meter), aspects of both this document and ISO 14155 can be considered.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Annex ZA (informative)Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
13 Foreword
14 Introduction
17 1 Scope
2 Normative references
18 3 Terms and definitions
27 4 Ethical considerations
4.1 General
4.2 Improper influence or inducement
4.3 Responsibilities
4.4 Ethics committee involvement
28 4.5 Informed consent
5 Clinical performance study planning
5.1 General
29 5.2 Risk evaluation
30 5.3 Design of the clinical performance study
5.4 Investigator brochure
31 5.5 Clinical Performance Study Protocol (CPSP)
5.5.1 General
5.5.2 Principal investigator responsibilities
32 5.5.3 Contents of the CPSP
35 5.6 Case report forms
36 5.7 Recording of specimen information
5.8 Specimen accountability and integrity
5.9 Study site selection
5.9.1 Site qualification
5.9.2 Site assessment
5.9.3 Site selection
37 5.10 Monitoring plan
5.11 Agreements
5.12 Labelling
6 Study site initiation
6.1 General
38 6.2 Prerequisites
6.3 Training
6.4 Initiation of the study site
39 7 Clinical performance study conduct
7.1 General
7.2 Responsibilities of the sponsor
7.3 Study site monitoring
7.3.1 General
7.3.2 Routine monitoring
40 7.3.3 Monitoring reports
41 7.4 Security and confidentiality of data
8 Close-out of the clinical performance study
8.1 Close-out activities
8.2 Clinical performance study report
43 8.3 Document retention
8.4 Suspension or premature termination of the clinical performance study
44 9 Auditing
45 Annex A (normative) Additional general requirements for certain studies
48 Annex B (normative) Clinical performance study protocol (CPSP)
52 Annex C (normative) Investigator brochure
54 Annex D (normative) Clinical performance study report
57 Annex E (normative) Communication with the ethics committee
59 Annex F (normative) Informed consent
63 Annex G (normative) Adverse event categorization
67 Annex H (informative) Good clinical performance study documentation
72 Annex I (informative) Auditing
73 Bibliography

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BS EN ISO 20916:2024
$215.11