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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.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
| LEADER | 00000cam a2200000Mi 4500 | ||
|---|---|---|---|
| 001 | EBSCO_ocn898769669 | ||
| 003 | OCoLC | ||
| 005 | 20231017213018.0 | ||
| 006 | m o d | ||
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| 008 | 141227s2014 mau ob 001 0 eng d | ||
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| 020 | |a 311028328X | ||
| 020 | |a 9783110283297 | ||
| 020 | |a 3110283298 | ||
| 020 | |a 9783110283280 |q (electronic bk.) | ||
| 020 | |z 9783110367645 | ||
| 020 | |z 3110367645 | ||
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| 020 | |a 9783110381597 | ||
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| 082 | 0 | 4 | |a 610.72/4 |2 23 |
| 084 | |a PZ 4700 |2 rvk | ||
| 049 | |a UAMI | ||
| 100 | 1 | |a Schriever, Karl-Heinz. | |
| 245 | 1 | 0 | |a G3P - Good Privacy Protection Practice in Clinical Research : |b Principles of Pseudonymization and Anonymization. |
| 260 | |a Berlin/Boston : |b De Gruyter, |c 2014. | ||
| 300 | |a 1 online resource (210 pages) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 588 | 0 | |a Print version record. | |
| 505 | 0 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 500 | |a 17.1 EMA definition of anonymous sample/data. | ||
| 520 | |a 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 patient related medical and genetic data. | ||
| 504 | |a Includes bibliographical references (pages 191-196) and index. | ||
| 546 | |a English. | ||
| 590 | |a eBooks on EBSCOhost |b EBSCO eBook Subscription Academic Collection - Worldwide | ||
| 650 | 0 | |a Clinical trials |x Research. | |
| 650 | 0 | |a Data protection. | |
| 650 | 0 | |a Medical care |x Research. | |
| 650 | 0 | |a Medical records |x Access control. | |
| 650 | 0 | |a Privacy, Right of. | |
| 650 | 0 | |a Confidential communications. | |
| 650 | 1 | 2 | |a Biomedical Research |
| 650 | 2 | 2 | |a Anonymous Testing |
| 650 | 2 | 2 | |a Confidentiality |
| 650 | 2 | 2 | |a Privacy |
| 650 | 6 | |a Études cliniques |x Recherche. | |
| 650 | 6 | |a Protection de l'information (Informatique) | |
| 650 | 6 | |a Soins médicaux |x Recherche. | |
| 650 | 6 | |a Dossiers médicaux |x Accès |x Contrôle. | |
| 650 | 6 | |a Secret professionnel. | |
| 650 | 7 | |a MEDICAL / Research. |2 bisacsh | |
| 650 | 7 | |a Confidential communications |2 fast | |
| 650 | 7 | |a Data protection |2 fast | |
| 650 | 7 | |a Medical care |x Research |2 fast | |
| 650 | 7 | |a Medical records |x Access control |2 fast | |
| 650 | 7 | |a Privacy, Right of |2 fast | |
| 650 | 7 | |a Medizin |2 gnd | |
| 650 | 7 | |a Datenschutz |2 gnd | |
| 700 | 1 | |a Schröder, Markus. | |
| 776 | 0 | 8 | |i Print version: |a Schriever, Karl-Heinz. |t G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. |d Berlin/Boston : De Gruyter, ©2014 |z 9783110367645 |
| 856 | 4 | 0 | |u https://ebsco.uam.elogim.com/login.aspx?direct=true&scope=site&db=nlebk&AN=909994 |z Texto completo |
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