The Resource G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization

G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization

Label
G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization
Title
G3P - Good Privacy Protection Practice in Clinical Research
Title remainder
Principles of Pseudonymization and Anonymization
Creator
Contributor
Subject
Language
eng
Summary
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
Cataloging source
EBLCP
Dewey number
610.72/4
Index
index present
LC call number
R853.C55
LC item number
S37 2014eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization
Publication
Note
17.1 EMA definition of anonymous sample/data
Bibliography note
Includes bibliographical references (pages 191-196) and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • 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
  • 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
  • 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
Control code
ocn898769669
Dimensions
unknown
Extent
1 online resource (210 pages)
Form of item
online
Isbn
9783110283280
Media category
computer
Media MARC source
rdamedia
Media type code
c
http://library.link/vocab/recordID
.b31970825
Specific material designation
remote
System control number
  • (OCoLC)898769669
  • pebcs311028328X

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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