G3P - good privacy protection practice in clinical research: principles of pseudonymization and anonymization
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Berlin
De Gruyter
[2017]
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110554366&searchTitles=true Inhaltsverzeichnis |
| Beschreibung: | XII, 198 Seiten Illustrationen 23 cm |
| ISBN: | 9783110554366 3110554364 |
Internformat
MARC
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Datensatz im Suchindex
| _version_ | 1804178958820835328 |
|---|---|
| adam_text | Table of contents
About the Authors----XI
1 Introduction—rl
2 Study Modes------3
2.1 Screening Mode - Pharmacogenetic Information for Screening---3
2.2 Pre- Unspecified Mode - Pharmacogenetic as Part of a Study---3
2.3 Possible Approaches, Summary- Clinical Trial With Genetic Part—-
2.4 Biobanks-What do we Mean by That?-------7
3 Protection Masks and Procedures---9
3.1 Identified Sam pies/Data---9
3.2 De-identified Samples/Data----10
3.3 Anonymized Samples/Data-------10
3.4 Re-identification---11
4 Coding Methods for De-identified Samples/Data----13
4.1 Single-coded Samples/Data-----13
4.2 Double-coded Samples/Data-----14
4.3 Triple-coded Samples/Data-----15
5 Relationships Among the Protection Masks----17
6 Data Types----19
7 Anonymization----23
7.1 Basic Terms and Ideas----23
7.2 Masking------24
7.3 Discarding the Key---30
7.4 Maintaining the Reliability of Stored Data-35
7.5 Security Measures----37
8 Validation - a Brief Introduction---43
8.1 Preliminaries---43
8.2 Basic Definitions Terms--43
8.3 General Principles of Computer System Validation--45
8.4 Primary Validation - Specification Phase---47
8.5 Primary Validation - Preparing Operational Use--51
8.6 Primary Validation - Testing Phase--58
VIII —— Table of contents
9 Request Management-------67
9.1 Genetic Review Board (GRB)----67
9.2 Request Specification--68
9.3 Subrequest Specification-—71
9.4 Involvement of External Service Providers----72
10 Legal Requirements Regulations-----75
10.1 Basic Ideas——75
10.2 Data Protection in the European Union (EU)---76
10.3 Transfer of Personal Data to Third Countries-92
10.4 Binding Corporate Rules---99
10.5 Data Protection in the United States (U.S.) - a Brief History-102
11 Informed Consent----109
11.1 Sections Mandatory for a Genetic Informed Consent---117
12 Selected Data Protection Medical Sites---125
12.1 Germany-----125
12.2 Europe----126
12.3 US----128
12.4 Global Initiatives--130
13 Impact of External Services on Data Protection----133
13.1 Introduction---133
13.2 Scenario 1 - Using GDI Throughout---135
13.3 Scenario 2 - Replacing GDI by nGDI Upon Sample Registration,
Performed by regCRO----136
13.4 Scenario 3 - Replacing GDI by nGDI Upon Sample Registration,
Performed by Sponsor——137
13.5 Scenario 4 - Sample Registration by CRO, Proprietary Labeling
withCROSID-----137
13.6 Scenario 5 - Barcoded Label bSID at Study Site-138
13.7 Overall Summary-----139
13.8 External Statistical Evaluation-140
13.9 External Biobanking----140
Table of contents
14 Practical Approach to Clinical Trials with Supplementary
Genetic Parts —141
14.1 introduction---141
14.2 Overall Project Topology--143
14.3 Checklist - Trial Set-up--144
14.4 Checklist - System Topology —-146
14.5 Checklist - Sample Management------146
14.6 Checklist - ICs, Ethics Committees Restrictions —148
14.7 Checklist-Anonymization-----149
14.8 Checklist - Statistical Evaluation —150
15 Appendix 1: Data Protection in the European Union----153
15.1 Council of Europe (COE)---153
15.2 EU Privacy Directive - Definitions-153
15.3 Tasks of the Article 29 Data Protection Working Party-154
16 Appendix 2: Data Types----157
16.1 EU Privacy Directive (October 24,1995)---157
16.2 Council of Europe (COE) Definition of Data Types-157
16.3 Federal Data Protection Act (GER) as of 1. Jan. 2003-160
17 Appendix 3: Protection Masks-----161
17.1 EMA definition of anonymous sample/data-----161
17.2 Germany------161
17.3 Spain----162
17.4 US-----163
18 Appendix 4: Informed Consent (1C)---167
18.1 The Nuremberg Code----167
18.2 EU Privacy Directive (October 24,1995)--168
18.3 COE - Rec No. R (97) 5, Explanatory Memorandum to Rec (97) 5--
18.4 Oviedo Convention-----174
18.5 UNESCO Universal Declaration on Bioethics and
Human Rights----175
18.6 Key Issues in Informed Consent for Pharmacogenomics
Research----176
18.7 International Declaration On Human Genetic Data------178
18.8 CIOMS - Ethical Guidelines for Biomedical Research----179
18.9 Human Genetic Examination Act
(Genetic Diagnosis Act - GenDG)---181
X
Table of contents
19 Appendix 5: Security--185
19.1 EU Privacy Directive (October 24,1995)-185
19.2 Federal Data Protection Act (Germany)--185
19.3 Council of Europe Recommendation No. R(97) 5----186
19.4 US - Privacy Act of 1974 (Comments from
William W. Lowrance, cf. (42))-187
19.5 Safe Harbor Privacy Principles (2000)--188
19.6 UN - ICCPR International Covenant on Civil and
Political Rights--188
20 Abbreviations---189
Anonymization-----189
General-----189
21 References -—191
Index---197
|
| any_adam_object | 1 |
| author | Schriever, Karl-Heinz 1948- Schröder, Markus 1960- |
| author_GND | (DE-588)1012822540 (DE-588)1060909561 |
| author_facet | Schriever, Karl-Heinz 1948- Schröder, Markus 1960- |
| author_role | aut aut |
| author_sort | Schriever, Karl-Heinz 1948- |
| author_variant | k h s khs m s ms |
| building | Verbundindex |
| bvnumber | BV045231456 |
| classification_rvk | PZ 4700 |
| ctrlnum | (OCoLC)985977453 (DE-599)DNB1130669556 |
| dewey-full | 610.724 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.724 |
| dewey-search | 610.724 |
| dewey-sort | 3610.724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Rechtswissenschaft Medizin |
| format | Book |
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| illustrated | Illustrated |
| indexdate | 2024-07-10T08:12:15Z |
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| isbn | 9783110554366 3110554364 |
| language | English |
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| spelling | Schriever, Karl-Heinz 1948- Verfasser (DE-588)1012822540 aut G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization Karl-Heinz Schriever, Markus Schröder Berlin De Gruyter [2017] XII, 198 Seiten Illustrationen 23 cm txt rdacontent n rdamedia nc rdacarrier Datensicherung (DE-588)4011144-1 gnd rswk-swf Anonymisierung (DE-588)4139362-4 gnd rswk-swf Datenschutz (DE-588)4011134-9 gnd rswk-swf Medizin (DE-588)4038243-6 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Privatsphäre (DE-588)4123980-5 gnd rswk-swf Klinische Medizin (DE-588)4134748-1 gnd rswk-swf Klinische Medizin (DE-588)4134748-1 s Forschung (DE-588)4017894-8 s Privatsphäre (DE-588)4123980-5 s Anonymisierung (DE-588)4139362-4 s Datensicherung (DE-588)4011144-1 s DE-604 Datenschutz (DE-588)4011134-9 s Medizin (DE-588)4038243-6 s 1\p DE-604 Schröder, Markus 1960- Verfasser (DE-588)1060909561 aut Walter de Gruyter GmbH & Co. KG (DE-588)10095502-2 pbl Erscheint auch als Online-Ausgabe Schriever, Karl-Heinz, 1948- G3P - Good Privacy Protection Practice in Clinical Research Berlin/Boston : De Gruyter, 2014 Online-Ressource, 40 Illustrationen B:DE-101 application/pdf http://d-nb.info/1130669556/04 Inhaltsverzeichnis X:MVB http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110554366&searchTitles=true Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030619833&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Schriever, Karl-Heinz 1948- Schröder, Markus 1960- G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization Datensicherung (DE-588)4011144-1 gnd Anonymisierung (DE-588)4139362-4 gnd Datenschutz (DE-588)4011134-9 gnd Medizin (DE-588)4038243-6 gnd Forschung (DE-588)4017894-8 gnd Privatsphäre (DE-588)4123980-5 gnd Klinische Medizin (DE-588)4134748-1 gnd |
| subject_GND | (DE-588)4011144-1 (DE-588)4139362-4 (DE-588)4011134-9 (DE-588)4038243-6 (DE-588)4017894-8 (DE-588)4123980-5 (DE-588)4134748-1 |
| title | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization |
| title_auth | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization |
| title_exact_search | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization |
| title_full | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization Karl-Heinz Schriever, Markus Schröder |
| title_fullStr | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization Karl-Heinz Schriever, Markus Schröder |
| title_full_unstemmed | G3P - good privacy protection practice in clinical research principles of pseudonymization and anonymization Karl-Heinz Schriever, Markus Schröder |
| title_short | G3P - good privacy protection practice in clinical research |
| title_sort | g3p good privacy protection practice in clinical research principles of pseudonymization and anonymization |
| title_sub | principles of pseudonymization and anonymization |
| topic | Datensicherung (DE-588)4011144-1 gnd Anonymisierung (DE-588)4139362-4 gnd Datenschutz (DE-588)4011134-9 gnd Medizin (DE-588)4038243-6 gnd Forschung (DE-588)4017894-8 gnd Privatsphäre (DE-588)4123980-5 gnd Klinische Medizin (DE-588)4134748-1 gnd |
| topic_facet | Datensicherung Anonymisierung Datenschutz Medizin Forschung Privatsphäre Klinische Medizin |
| url | http://d-nb.info/1130669556/04 http://www.degruyter.com/search?f_0=isbnissn&q_0=9783110554366&searchTitles=true http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030619833&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT schrieverkarlheinz g3pgoodprivacyprotectionpracticeinclinicalresearchprinciplesofpseudonymizationandanonymization AT schrodermarkus g3pgoodprivacyprotectionpracticeinclinicalresearchprinciplesofpseudonymizationandanonymization AT walterdegruytergmbhcokg g3pgoodprivacyprotectionpracticeinclinicalresearchprinciplesofpseudonymizationandanonymization |
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