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

Karl-Heinz Schriever; Markus Schröder

Published by De Gruyter 2014

G3P - Good Privacy Protection Practice in Clinical Research

Principles of Pseudonymization and Anonymization

Karl-Heinz Schriever and Markus Schröder

https://doi.org/10.1515/9783110283280

Overview
Contents

About this book

Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection.
The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented.
Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.

Practical guide, providing the required high degree of data protection
Systematic approach to data protection in clinical research.
Technical requirements of data protection (pseudonymization and anonymization)

Author / Editor information

K.-H. Schriever, University of Applied Sciences at Biberach, Germany; M. Schröder, Tembit Software GmbH, Berlin, Germany

Topics

Frontmatter Publicly Available Download PDF	I
Table of contents Publicly Available Download PDF	VII
About the Authors Requires Authentication Unlicensed Licensed Download PDF	XI
1. Introduction Requires Authentication Unlicensed Licensed Download PDF	1
2. Study Modes Requires Authentication Unlicensed Licensed Download PDF	3
3. Protection Masks and Procedures Requires Authentication Unlicensed Licensed Download PDF	9
4. Coding Methods for De-identified Samples/Data Requires Authentication Unlicensed Licensed Download PDF	13
5. Relationships Among the Protection Masks Requires Authentication Unlicensed Licensed Download PDF	17
6. Data Types Requires Authentication Unlicensed Licensed Download PDF	19
7. Anonymization Requires Authentication Unlicensed Licensed Download PDF	23
8. Validation – a Brief Introduction Requires Authentication Unlicensed Licensed Download PDF	43
9. Request Management Requires Authentication Unlicensed Licensed Download PDF	67
10. Legal Requirements & Regulations Requires Authentication Unlicensed Licensed Download PDF	75
11. Informed Consent Requires Authentication Unlicensed Licensed Download PDF	109
12. Selected Data Protection & Medical Sites Requires Authentication Unlicensed Licensed Download PDF	125
13. Impact of External Services on Data Protection Requires Authentication Unlicensed Licensed Download PDF	133
14. Practical Approach to Clinical Trials with Supplementary Genetic Parts Requires Authentication Unlicensed Licensed Download PDF	141
15. Appendix 1: Data Protection in the European Union Requires Authentication Unlicensed Licensed Download PDF	153
16. Appendix 2: Data Types Requires Authentication Unlicensed Licensed Download PDF	157
17. Appendix 3: Protection Masks Requires Authentication Unlicensed Licensed Download PDF	161
18. Appendix 4: Informed Consent (IC) Requires Authentication Unlicensed Licensed Download PDF	167
19. Appendix 5: Security Requires Authentication Unlicensed Licensed Download PDF	185
20. Abbreviations Requires Authentication Unlicensed Licensed Download PDF	189
21. References Requires Authentication Unlicensed Licensed Download PDF	191
Index Requires Authentication Unlicensed Licensed Download PDF	197

(Deutsch)

Language: English
Publisher: De Gruyter
Audience: All stakeholders in clincal trials and research, Data-protection supervisors in hospitals, Payers in the health sector
Pages
- Front matter: 12
- Main content: 198
Illustrations
- Illustrations: 40

eBook

Published: October 2, 2014
ISBN: 9783110283280

Hardcover

Published: September 15, 2014
ISBN: 9783110367645

Paperback

Published: June 26, 2017
ISBN: 9783110554366