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BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice >
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BS EN ISO 14155:2020+A11:2024 Clinical investigation of medical devices for human subjects. Good clinical practice, 2025
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- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Summary of good clinical practice (GCP) principles
- 5 Ethical considerations
- 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)
- 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
- 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
- 6.1 General
- 6.2 Risk management
- 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
- 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
- 7.4.3 Device deficiencies
- 7.4.4 Risk assessment process for potentially unacceptable risks
- 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
- 7.8 Document and data control
- 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
- 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
- 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
- 9.1 Clinical quality management
- 9.2 Clinical investigation planning and conduct
- 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
- 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
- Bibliography [Go to Page]
