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BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice >
BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice, 2024
- undefined [Go to Page]
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Ethical considerations
- 4.1 General
- 4.2 Improper influence or inducement
- 4.3 Responsibilities
- 4.4 Ethics committee involvement
- 4.5 Informed consent
- 5 Clinical performance study planning
- 5.1 General
- 5.2 Risk evaluation
- 5.3 Design of the clinical performance study
- 5.4 Investigator brochure
- 5.5 Clinical Performance Study Protocol (CPSP)
- 5.5.1 General
- 5.5.2 Principal investigator responsibilities
- 5.5.3 Contents of the CPSP
- 5.6 Case report forms
- 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
- 5.10 Monitoring plan
- 5.11 Agreements
- 5.12 Labelling
- 6 Study site initiation
- 6.1 General
- 6.2 Prerequisites
- 6.3 Training
- 6.4 Initiation of the study site
- 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
- 7.3.3 Monitoring reports
- 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
- 8.3 Document retention
- 8.4 Suspension or premature termination of the clinical performance study
- 9 Auditing
- Annex A (normative) Additional general requirements for certain studies
- Annex B (normative) Clinical performance study protocol (CPSP)
- Annex C (normative) Investigator brochure
- Annex D (normative) Clinical performance study report
- Annex E (normative) Communication with the ethics committee
- Annex F (normative) Informed consent
- Annex G (normative) Adverse event categorization
- Annex H (informative) Good clinical performance study documentation
- Annex I (informative) Auditing
- Bibliography [Go to Page]