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.

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...

Full description

Saved in:
Bibliographic Details
Main Author: Schriever, Karl-Heinz
Other Authors: Schröder, Markus
Format: eBook
Language:English
Published: Berlin/Boston : De Gruyter, 2014.
Subjects:
Clinical trials > Research.
Data protection.
Medical care > Research.
Medical records > Access control.
Privacy, Right of.
Confidential communications.
MEDICAL / Research.
Confidential communications
Data protection
Medical care > Research
Medical records > Access control
Privacy, Right of
Medizin
Datenschutz
Online Access:Click for online access
Table of 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.
  • 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.

Similar Items