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G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization.
Medical and genetic information from medical research must be protected against unauthorized access and replication. This book is a practical guide demonstrating how coding methods, providing the required high degree of data protection, can be integrated into respective applications dealing with pat...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Berlin/Boston :
De Gruyter,
2014.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- About the Authors; 1 Introduction; 2 Study Modes; 2.1 Screening Mode
- Pharmacogenetic Information for Screening; 2.2 Pre- Unspecified Mode
- Pharmacogenetic as Part of a Study; 2.3 Possible Approaches, Summary
- Clinical Trial With Genetic Part; 2.4 Biobanks
- What do we Mean by That?; 3 Protection Masks and Procedures; 3.1 Identified Samples/Data; 3.2 De-identified Samples/Data; 3.3 Anonymized Samples/Data; 3.4 Re-identification; 4 Coding Methods for De-identified Samples/Data; 4.1 Single-coded Samples/Data; 4.2 Double-coded Samples/Data; 4.3 Triple-coded Samples/Data.
- 5 Relationships Among the Protection Masks6 Data Types; 7 Anonymization; 7.1 Basic Terms and Ideas; 7.2 Masking; 7.3 Discarding the Key; 7.4 Maintaining the Reliability of Stored Data; 7.5 Security Measures; 8 Validation
- a Brief Introduction; 8.1 Preliminaries; 8.2 Basic Definitions & Terms; 8.3 General Principles of Computer System Validation; 8.4 Primary Validation
- Specification Phase; 8.5 Primary Validation
- Preparing Operational Use; 8.6 Primary Validation
- Testing Phase; 9 Request Management; 9.1 Genetic Review Board (GRB); 9.2 Request Specification; 9.3 Subrequest Specification.
- 9.4 Involvement of External Service Providers10 Legal Requirements & Regulations; 10.1 Basic Ideas; 10.2 Data Protection in the European Union (EU); 10.3 Transfer of Personal Data to Third Countries; 10.4 Binding Corporate Rules; 10.5 Data Protection in the United States (U.S.)
- a Brief History; 11 Informed Consent; 11.1 Sections Mandatory for a Genetic Informed Consent; 12 Selected Data Protection & Medical Sites; 12.1 Germany; 12.2 Europe; 12.3 US; 12.4 Global Initiatives; 13 Impact of External Services on Data Protection; 13.1 Introduction; 13.2 Scenario 1
- Using GDI Throughout.
- 13.3 Scenario 2
- Replacing GDI by nGDI Upon Sample Registration, Performed by regCRO13.4 Scenario 3
- Replacing GDI by nGDI Upon Sample Registration, Performed by Sponsor; 13.5 Scenario 4
- Sample Registration by CRO, Proprietary Labeling with CROSID; 13.6 Scenario 5
- Barcoded Label bSID at Study Site; 13.7 Overall Summary; 13.8 External Statistical Evaluation; 13.9 External Biobanking; 14 Practical Approach to Clinical Trials with Supplementary Genetic Parts; 14.1 Introduction; 14.2 Overall Project Topology; 14.3 Checklist
- Trial Set-up; 14.4 Checklist
- System Topology.
- 14.5 Checklist
- Sample Management14.6 Checklist
- ICs, Ethics Committees Restrictions; 14.7 Checklist
- Anonymization; 14.8 Checklist
- Statistical Evaluation; 15 Appendix 1: Data Protection in the European Union; 15.1 Council of Europe (COE); 15.2 EU Privacy Directive
- Definitions; 15.3 Tasks of the Article 29 Data Protection Working Party; 16 Appendix 2: Data Types; 16.1 EU Privacy Directive (October 24, 1995); 16.2 Council of Europe (COE) Definition of Data Types; 16.3 Federal Data Protection Act (GER) as of 1. Jan. 2003; 17 Appendix 3: Protection Masks.