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BS EN ISO 14155:2020

BS EN ISO 14155:2020

$215.11

Clinical investigation of medical devices for human subjects. Good clinical practice

Published By Publication Date Number of Pages
BSI 2020 96
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This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).

This document specifies general requirements intended to

  1. protect the rights, safety and well-being of human subjects,

  2. ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,

  3. define the responsibilities of the sponsor and principal investigator, and

  4. assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

NOTE 1

Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.

NOTE 2

For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD’s output is accurate for a given input), and where appropriate, the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [ 4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.

This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
5 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
7 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
11 Foreword
13 1 Scope
2 Normative references
3 Terms and definitions
21 4 Summary of good clinical practice (GCP) principles
22 5 Ethical considerations
5.1 General
5.2 Improper influence or inducement
5.3 Compensation and additional health care
23 5.4 Registration in publicly accessible database
5.5 Responsibilities
5.6 Communication with the ethics committee (EC)
5.6.1 General
5.6.2 Initial EC submission
24 5.6.3 Information to be obtained from the EC
5.6.4 Continuing communication with the EC
5.6.5 Continuing information to be obtained from the EC
5.7 Vulnerable populations
25 5.8 Informed consent
5.8.1 General
5.8.2 Process of obtaining informed consent
26 5.8.3 Special circumstances for informed consent
27 5.8.4 Information to be provided to the subject
29 5.8.5 Informed consent signature
5.8.6 New information
6 Clinical investigation planning
6.1 General
6.2 Risk management
6.2.1 General
30 6.2.2 Investigational device including clinical procedure risks and their disclosure
6.2.3 Clinical investigation process
6.3 Justification for the design of the clinical investigation
31 6.4 Clinical investigation plan (CIP)
6.5 Investigator’s brochure (IB)
6.6 Case report forms (CRFs)
32 6.7 ​Monitoring plan
33 6.8 Investigation site selection
6.9 Agreement(s)
6.10 Labelling
6.11 Data monitoring committee (DMC)
34 7 Clinical investigation conduct
7.1 General
7.2 Investigation site initiation
7.3 Investigation site monitoring
7.4 Adverse events and device deficiencies
7.4.1 Signals requiring immediate action
7.4.2 Adverse events
35 7.4.3 Device deficiencies
7.4.4 Risk assessment process for potentially unacceptable risks
36 7.5 Clinical investigation documents and documentation
7.5.1 Amendments
7.5.2 Subject identification log
7.5.3 Source documents
7.6 Additional members of the investigation site team
7.7 Subject privacy and confidentiality of data
37 7.8 Document and data control
7.8.1 Traceability of documents and data
7.8.2 Recording of data
38 7.8.3 Electronic clinical data systems
7.9 Investigational device accountability
39 7.10 Accounting for subjects
7.11 Auditing
40 8 Suspension, termination, and close-out of the clinical investigation
8.1 Completion of the clinical investigation
8.2 Suspension or premature termination of the clinical investigation
8.2.1 Procedure for suspension or premature termination
41 8.2.2 Procedure for resuming the clinical investigation after temporary suspension
8.3 Routine close-out
8.4 Clinical investigation report
42 8.5 Risk assessment and conclusions
8.6 Document retention
9 Responsibilities of the sponsor
9.1 Clinical quality management
43 9.2 Clinical investigation planning and conduct
9.2.1 Selection and training of clinical personnel
44 9.2.2 Preparation of documents and materials
9.2.3 Conduct of clinical investigation
45 9.2.4 ​Monitoring
48 9.2.5 Safety evaluation and reporting
9.2.6 Clinical investigation close-out
49 9.3 Outsourcing of duties and functions
9.4 Communication with regulatory authorities
10 Responsibilities of the principal investigator
10.1 General
50 10.2 Qualification of the principal investigator
10.3 Qualification of investigation site
10.4 Communication with the EC
51 10.5 Informed consent process
10.6 ​Compliance with the CIP
52 10.7 Medical care of subjects
10.8 Safety reporting
53 Annex A (normative) Clinical investigation plan (CIP)
62 Annex B (normative) Investigator’s brochure (IB)
65 Annex C (informative) Case report forms (CRFs)
67 Annex D (normative) Clinical investigation report
72 Annex E (informative) Essential clinical investigation documents
79 Annex F (informative) Adverse event categorization
81 Annex G (informative) EC responsibilities
85 Annex H (informative) Application of ISO 14971 to clinical investigations
86 Annex I (informative) Clinical development stages
91 Annex J (informative) Clinical investigation audits

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BS EN ISO 14155:2020
$215.11