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BS EN ISO 14155:2020 - TC Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice, 2020
- National foreword [Go to Page]
- Compliance with a British Standard cannot confer immunity from legal obligations.
- Amendments/corrigenda issued since publication
- Annex ZA
- (informative)
- Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices
- Annex ZB
- (informative)
- Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices
- 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 [Go to Page]
- INTERNATIONAL STANDARD
- 2 Normative references
- 3 Terms and definitions [Go to Page]
- 3.1
- 3.2
- 3.3
- 3.4
- 3.43.5
- 3.53.6
- 3.7
- 3.63.8
- 3.73.9
- 3.83.10
- 3.93.11
- 3.103.12
- 3.13
- 3.113.14
- 3.15
- 3.123.16
- 3.133.17
- 3.143.18
- 3.153.19
- 3.20
- 3.21 [Go to Page]
- combination of text, graphics, data, audio, imaging, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system (3.13)
- 3.163.22
- 3.173.23
- 3.183.24
- 3.193.25
- 3.203.26
- 3.213.27
- 3.223.28
- 3.233.29
- 3.243.30
- 3.253.31
- 3.263.32
- 3.273.33
- 3.283.34
- 3.293.35
- 3.303.36
- 3.313.37
- 3.323.38
- 3.333.39
- 3.40
- 3.41
- 3.343.42
- 3.353.43
- 3.363.44
- 3.373.45
- 3.46
- 3.383.47
- 3.393.48
- 3.403.49
- 3.413.50
- 3.423.51
- 3.433.52
- 3.53
- 3.54
- 3.443.55
- 4 Ethical considerations [Go to Page]
- 4.1 General
- 4 Summary of good clinical practice (GCP) principles
- 5 Ethical considerations [Go to Page]
- 5.1 General
- 4.25.2 Improper influence or inducement
- 4.35.3 Compensation and additional health care
- 5.4 Registration in publicly accessible database
- 4.45.5 Responsibilities
- 4.55.6 Communication with the ethics committee (EC) [Go to Page]
- 4.5.15.6.1 General
- 4.5.25.6.2 Initial EC submission
- 4.5.35.6.3 Information to be obtained from the EC
- 4.5.45.6.4 Continuing communication with the EC
- 4.5.55.6.5 Continuing information to be obtained from the EC
- 4.65.7 Vulnerable populations
- 4.75.8 Informed consent [Go to Page]
- 4.7.15.8.1 General
- 4.7.25.8.2 Process of obtaining informed consent
- 4.7.35.8.3 Special circumstances for informed consent
- 4.7.3.25.8.3.2 Subject needing legally authorizeddesignated representatives
- 4.7.3.35.8.3.3 Subject unable to read or write
- 4.7.3.45.8.3.4 Emergency treatments
- 4.7.45.8.4 Information to be provided to the subject
- 4.7.55.8.5 Informed consent signature
- 4.7.65.8.6 New information
- 56 Clinical investigation planning [Go to Page]
- 5.16.1 General
- 5.2 Risk evaluation
- 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
- 5.36.3 Justification for the design of the clinical investigation
- 5.46.4 Clinical investigation plan (CIP)
- 5.56.5 Investigator's brochure (IB)
- 5.66.6 Case report forms (CRFs)
- 5.76.7 Monitoring plan
- 5.86.8 Investigation site selection
- 5.96.9 Agreement(s)
- 5.106.10 Labelling
- 5.116.11 Data monitoring committee (DMC)
- 67 Clinical investigation conduct [Go to Page]
- 6.17.1 General
- 6.27.2 Investigation site initiation
- 6.37.3 Investigation site monitoring
- 6.47.4 Adverse events and device deficiencies [Go to Page]
- 7.4.1 Signals requiring immediate action
- 6.4.17.4.2 Adverse events
- 6.4.27.4.3 Device deficiencies
- 7.4.4 Risk assessment process for potentially unacceptable risks
- 6.57.5 Clinical investigation documents and documentation [Go to Page]
- 6.5.17.5.1 Amendments
- 6.5.27.5.2 Subject identification log
- 6.5.37.5.3 Source documents
- 6.67.6 Additional members of the investigation site team
- 6.77.7 Subject privacy and confidentiality of data
- 6.87.8 Document and data control [Go to Page]
- 6.8.17.8.1 Traceability of documents and data
- 6.8.27.8.2 Recording of data
- 6.8.37.8.3 Electronic clinical data systems
- 6.97.9 Investigational device accountability
- 6.107.10 Accounting for subjects
- 6.117.11 Auditing
- 78 Suspension, termination, and close-out of the clinical investigation [Go to Page]
- 8.1 Completion of the clinical investigation
- 7.18.2 Suspension or premature termination of the clinical investigation [Go to Page]
- 7.1.18.2.1 Procedure for suspension or premature termination
- 7.1.28.2.2 Procedure for resuming the clinical investigation after temporary suspension
- 7.28.3 Routine close-out
- 7.38.4 Clinical investigation report
- 8.5 Risk assessment and conclusions
- 7.48.6 Document retention
- 89 Responsibilities of the sponsor [Go to Page]
- 8.19.1 Clinical quality assurance and quality controlmanagement
- 8.29.2 Clinical investigation planning and conduct [Go to Page]
- 8.2.19.2.1 Selection and training of clinical personnel
- 8.2.29.2.2 Preparation of documents and materials
- 8.2.39.2.3 Conduct of clinical investigation
- 8.2.49.2.4 Monitoring
- 8.2.4.29.2.4.2 Qualifications of the monitor
- 8.2.4.39.2.4.3 Assessment of the investigation site
- 8.2.4.49.2.4.4 Initiation of the investigation site
- 8.2.4.59.2.4.5 Routine on-site monitoring visits
- 8.2.4.69.2.4.6 Close-out activities
- 8.2.4.79.2.4.7 Monitoring reports
- 8.2.59.2.5 Safety evaluation and reporting
- 8.2.69.2.6 Clinical investigation close-out
- 8.39.3 Outsourcing of duties and functions
- 8.49.4 Communication with regulatory authorities
- 910 Responsibilities of the principal investigator [Go to Page]
- 9.110.1 General
- 9.210.2 Qualification of the principal investigator
- 9.310.3 Qualification of investigation site
- 9.410.4 Communication with the EC
- 9.510.5 Informed consent process
- 9.610.6 Compliance with the CIP
- 9.710.7 Medical care of subjects
- 9.810.8 Safety reporting
- Annex A
- Clinical investigation plan (CIP) [Go to Page]
- A.1 General [Go to Page]
- A.1.1 Introduction
- A.1.2 Identification of the clinical investigation plan
- A.1.3 Sponsor
- A.1.4 Principal investigator, coordinating investigator and investigation site(s)
- A.1.5 Overall synopsis of the clinical investigation
- A.2 Identification and description of the investigational device
- A.3 Justification for the design of the clinical investigation
- A.4 RisksBenefits and benefitsrisks of the investigational device, clinical procedure, and clinical investigation
- A.5 Objectives and hypotheses of the clinical investigation
- A.6 Design of the clinical investigation [Go to Page]
- A.6.1 General
- A.6.2 Investigational device(s) and comparator(s)
- A.6.3 Subjects
- A.6.4 Procedures
- A.6.5 Monitoring plan
- A.7 Statistical considerationsdesign and analysis
- A.8 Data management
- A.9 Amendments to the CIP
- A.10 Deviations from clinical investigation plan
- A.11 Device accountability
- A.12 Statements of compliance
- A.13 Informed consent process
- A.14 Adverse events, adverse device effects, and device deficiencies
- A.15 Vulnerable population (if applicable)
- A.16 Suspension or premature termination of the clinical investigation
- A.17 Publication policy
- A.18 Bibliography
- Annex B
- Investigator's brochure (IB) [Go to Page]
- B.1 General [Go to Page]
- B.1.1 Introduction
- B.1.2 Identification of the IB
- B.1.3 Sponsor/manufacturer
- B.2 Investigational device information
- B.3 Preclinical testing
- B.4 Existing clinical data
- B.5 Risk management of the investigational device
- B.6 Regulatory and other references
- Annex C
- Case report forms (CRFs) [Go to Page]
- C.1 General
- C.2 Content and format [Go to Page]
- C.2.1 Overall considerations
- C.2.2 Cover page/login screen
- C.2.3 Header or footer/e-CRF identifier
- C.2.4 Types of CRF
- C.3 Procedural issues
- Annex D
- Clinical investigation report [Go to Page]
- D.1 General
- D.2 Cover page
- D.3 Table of contents
- D.4 Summary
- D.5 Introduction
- D.6 Investigational device and methods [Go to Page]
- D.6.1 Investigational device description
- D.6.2 Clinical investigation plan (CIP)
- D.7 Results
- D.8 Discussion and overall conclusions
- D.9 Abbreviated terms and definitions
- D.10 Ethics
- D.11 Investigators and administrative structure of clinical investigation
- D.12 Signature page
- D.13 Annexes to the report
- Annex E
- Essential clinical investigation documents [Go to Page]
- Table E.1 — Essential clinical investigation documents prior to clinical investigation
- Table E.1 — Essential clinical investigation documents prior to clinical investigation [Go to Page]
- Table E.2 — Essential clinical investigation documents during clinical investigation
- Table E.2 — Essential clinical investigation documents during clinical investigation [Go to Page]
- Table E.3 — Essential clinical investigation documents after clinical investigation
- Annex F
- Adverse event categorization [Go to Page]
- Table F.1 — Categories of adverse events
- Figure F.1 — Adverse events categorization chart
- Figure F.1 — Adverse events categorization chart
- Annex G
- EC responsibilities [Go to Page]
- G.1 General
- G.2 Responsibilities
- G.3 Composition, functions, and operations
- G.4 Information needed
- G.5 Procedures
- G.6 EC approval/favourable opinion letters
- G.7 Records
- Annex H
- Application of ISO 14971 to clinical investigations
- Annex I
- Clinical development stages [Go to Page]
- I.1 Background
- I.2 Regulatory status [Go to Page]
- I.2.1 General
- I.2.2 Pre-market clinical investigation
- I.2.3 Post-market clinical investigation
- I.3 Clinical development stages [Go to Page]
- I.3.1 General
- I.3.2 Pilot stage
- I.3.3 Pivotal stage
- I.3.4 Post-market stage
- I.4 Type of clinical investigation design [Go to Page]
- I.4.1 General
- I.4.2 Exploratory clinical investigation
- I.4.3 Confirmatory clinical investigation
- I.4.4 Observational clinical investigation
- I.5 Descriptors of clinical investigations [Go to Page]
- I.5.1 General
- I.5.2 First in human clinical investigation
- I.5.3 Early feasibility clinical investigation
- I.5.4 Traditional feasibility clinical investigation
- I.5.5 Pivotal clinical investigation
- I.5.6 Registry
- I.6 Burden to subjects [Go to Page]
- I.6.1 General
- I.6.2 Interventional clinical investigation
- I.6.3 Non-interventional clinical investigation
- I.7 Applicability of this document’s principles
- Annex J
- Clinical investigation audits [Go to Page]
- J.1 General
- J.2 Sponsor
- J.3 Investigation site
- Bibliography
- 30344903-WEB.pdf [Go to Page]
- undefined [Go to Page]
- 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
- 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]
