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eLibrary > BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice >

BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice, 2020

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BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice, 2020

National foreword
European foreword
Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Summary of good clinical practice (GCP) principles
5 Ethical considerations [Go to Page]
5.1 General
5.2 Improper influence or inducement
5.3 Compensation and additional health care
5.4 Registration in publicly accessible database
5.5 Responsibilities
5.6 Communication with the ethics committee (EC) [Go to Page]
5.6.1 General
5.6.2 Initial EC submission
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
5.8 Informed consent [Go to Page]
5.8.1 General
5.8.2 Process of obtaining informed consent
5.8.3 Special circumstances for informed consent
5.8.4 Information to be provided to the subject
5.8.5 Informed consent signature
5.8.6 New information
6 Clinical investigation planning [Go to Page]
6.1 General
6.2 Risk management [Go to Page]
6.2.1 General
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
6.4 Clinical investigation plan (CIP)
6.5 Investigator's brochure (IB)
6.6 Case report forms (CRFs)
6.7 Monitoring plan
6.8 Investigation site selection
6.9 Agreement(s)
6.10 Labelling
6.11 Data monitoring committee (DMC)
7 Clinical investigation conduct [Go to Page]
7.1 General
7.2 Investigation site initiation
7.3 Investigation site monitoring
7.4 Adverse events and device deficiencies [Go to Page]
7.4.1 Signals requiring immediate action
7.4.2 Adverse events
7.4.3 Device deficiencies
7.4.4 Risk assessment process for potentially unacceptable risks
7.5 Clinical investigation documents and documentation [Go to Page]
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
7.8 Document and data control [Go to Page]
7.8.1 Traceability of documents and data
7.8.2 Recording of data
7.8.3 Electronic clinical data systems
7.9 Investigational device accountability
7.10 Accounting for subjects
7.11 Auditing
8 Suspension, termination, and close-out of the clinical investigation [Go to Page]
8.1 Completion of the clinical investigation
8.2 Suspension or premature termination of the clinical investigation [Go to Page]
8.2.1 Procedure for suspension or premature termination
8.2.2 Procedure for resuming the clinical investigation after temporary suspension
8.3 Routine close-out
8.4 Clinical investigation report
8.5 Risk assessment and conclusions
8.6 Document retention
9 Responsibilities of the sponsor [Go to Page]
9.1 Clinical quality management
9.2 Clinical investigation planning and conduct [Go to Page]
9.2.1 Selection and training of clinical personnel
9.2.2 Preparation of documents and materials
9.2.3 Conduct of clinical investigation
9.2.4 Monitoring
9.2.5 Safety evaluation and reporting
9.2.6 Clinical investigation close-out
9.3 Outsourcing of duties and functions
9.4 Communication with regulatory authorities
10 Responsibilities of the principal investigator [Go to Page]
10.1 General
10.2 Qualification of the principal investigator
10.3 Qualification of investigation site
10.4 Communication with the EC
10.5 Informed consent process
10.6 Compliance with the CIP
10.7 Medical care of subjects
10.8 Safety reporting
Annex A (normative) Clinical investigation plan (CIP)
Annex B (normative) Investigator's brochure (IB)
Annex C (informative) Case report forms (CRFs)
Annex D (normative) Clinical investigation report
Annex E (informative) Essential clinical investigation documents
Annex F (informative) Adverse event categorization
Annex G (informative) EC responsibilities
Annex H (informative) Application of ISO 14971 to clinical investigations
Annex I (informative) Clinical development stages
Annex J (informative) Clinical investigation audits [Go to Page]

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BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice, 2020

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