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...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Weitere Verfasser: | |
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Berlin/Boston :
De Gruyter,
2014.
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | 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. |
| Beschreibung: | 17.1 EMA definition of anonymous sample/data. |
| Beschreibung: | 1 online resource (210 pages) |
| Bibliographie: | Includes bibliographical references (pages 191-196) and index. |
| ISBN: | 311028328X 9783110283297 3110283298 9783110283280 3110381591 9783110381597 |
Internformat
MARC
| LEADER | 00000cam a2200000 i 4500 | ||
|---|---|---|---|
| 001 | ZDB-4-EBA-ocn898769669 | ||
| 003 | OCoLC | ||
| 005 | 20241004212047.0 | ||
| 006 | m o d | ||
| 007 | cr |n||||||||| | ||
| 008 | 141227s2014 mau ob 001 0 eng d | ||
| 010 | |a 2014017116 | ||
| 040 | |a EBLCP |b eng |e pn |c EBLCP |d OCLCQ |d YDXCP |d E7B |d CCO |d OCLCO |d DEBSZ |d OCLCQ |d AZK |d OCLCQ |d COCUF |d PIFAG |d ZCU |d MERUC |d DEGRU |d U3W |d UIU |d STF |d OCLCF |d OCLCQ |d ICG |d VT2 |d OCLCO |d OCLCQ |d WYU |d OCLCA |d TKN |d LEAUB |d DKC |d OCLCO |d OCLCQ |d UX1 |d OCLCQ |d N$T |d OCLCA |d K6U |d U9X |d VLY |d AUD |d BRF |d OCLCQ |d OCLCO |d OCL |d OCLCQ |d QGK |d OCLCO |d OCLCL |d UEJ |d OCLCQ | ||
| 019 | |a 899591384 |a 961511398 |a 962631912 |a 979584791 |a 1055394992 |a 1066651588 |a 1081296984 |a 1107345909 |a 1162496816 |a 1228564800 |a 1259054791 | ||
| 020 | |a 311028328X | ||
| 020 | |a 9783110283297 | ||
| 020 | |a 3110283298 | ||
| 020 | |a 9783110283280 |q (electronic bk.) | ||
| 020 | |z 9783110367645 | ||
| 020 | |z 3110367645 | ||
| 020 | |a 3110381591 | ||
| 020 | |a 9783110381597 | ||
| 024 | 7 | |a 10.1515/9783110283280 |2 doi | |
| 035 | |a (OCoLC)898769669 |z (OCoLC)899591384 |z (OCoLC)961511398 |z (OCoLC)962631912 |z (OCoLC)979584791 |z (OCoLC)1055394992 |z (OCoLC)1066651588 |z (OCoLC)1081296984 |z (OCoLC)1107345909 |z (OCoLC)1162496816 |z (OCoLC)1228564800 |z (OCoLC)1259054791 | ||
| 050 | 4 | |a R853.C55 |b S37 2014eb | |
| 060 | 4 | |a W 20.5 | |
| 072 | 7 | |a MED106000 |2 bisacsh | |
| 082 | 7 | |a 610.72/4 |2 23 | |
| 084 | |a PZ 4700 |2 rvk | ||
| 049 | |a MAIN | ||
| 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. | ||
| 650 | 0 | |a Clinical trials |x Research. | |
| 650 | 0 | |a Data protection. |0 http://id.loc.gov/authorities/subjects/sh85035859 | |
| 650 | 0 | |a Medical care |x Research. |0 http://id.loc.gov/authorities/subjects/sh85082882 | |
| 650 | 0 | |a Medical records |x Access control. |0 http://id.loc.gov/authorities/subjects/sh85083012 | |
| 650 | 0 | |a Privacy, Right of. |0 http://id.loc.gov/authorities/subjects/sh85107029 | |
| 650 | 0 | |a Confidential communications. |0 http://id.loc.gov/authorities/subjects/sh85030929 | |
| 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 |0 http://d-nb.info/gnd/4038243-6 | |
| 650 | 7 | |a Datenschutz |2 gnd |0 http://d-nb.info/gnd/4011134-9 | |
| 700 | 1 | |a Schröder, Markus. | |
| 758 | |i has work: |a G3P (Text) |1 https://id.oclc.org/worldcat/entity/E39PCFtqFWpdVC4gr7ybr4fpfq |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 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 | |l FWS01 |p ZDB-4-EBA |q FWS_PDA_EBA |u https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=909994 |3 Volltext |
| 936 | |a BATCHLOAD | ||
| 938 | |a De Gruyter |b DEGR |n 9783110283280 | ||
| 938 | |a EBL - Ebook Library |b EBLB |n EBL1685362 | ||
| 938 | |a ebrary |b EBRY |n ebr11006632 | ||
| 938 | |a YBP Library Services |b YANK |n 11725008 | ||
| 938 | |a EBSCOhost |b EBSC |n 909994 | ||
| 994 | |a 92 |b GEBAY | ||
| 912 | |a ZDB-4-EBA | ||
| 049 | |a DE-863 | ||
Datensatz im Suchindex
| DE-BY-FWS_katkey | ZDB-4-EBA-ocn898769669 |
|---|---|
| _version_ | 1816882297771655169 |
| adam_text | |
| any_adam_object | |
| author | Schriever, Karl-Heinz |
| author2 | Schröder, Markus |
| author2_role | |
| author2_variant | m s ms |
| author_facet | Schriever, Karl-Heinz Schröder, Markus |
| author_role | |
| author_sort | Schriever, Karl-Heinz |
| author_variant | k h s khs |
| building | Verbundindex |
| bvnumber | localFWS |
| callnumber-first | R - Medicine |
| callnumber-label | R853 |
| callnumber-raw | R853.C55 S37 2014eb |
| callnumber-search | R853.C55 S37 2014eb |
| callnumber-sort | R 3853 C55 S37 42014EB |
| callnumber-subject | R - General Medicine |
| classification_rvk | PZ 4700 |
| collection | ZDB-4-EBA |
| 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. |
| ctrlnum | (OCoLC)898769669 |
| dewey-full | 610.72/4 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.72/4 |
| dewey-search | 610.72/4 |
| dewey-sort | 3610.72 14 |
| dewey-tens | 610 - Medicine and health |
| discipline | Rechtswissenschaft Medizin |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>07439cam a2200937 i 4500</leader><controlfield tag="001">ZDB-4-EBA-ocn898769669</controlfield><controlfield tag="003">OCoLC</controlfield><controlfield tag="005">20241004212047.0</controlfield><controlfield tag="006">m o d </controlfield><controlfield tag="007">cr |n|||||||||</controlfield><controlfield tag="008">141227s2014 mau ob 001 0 eng d</controlfield><datafield tag="010" ind1=" " ind2=" "><subfield code="a"> 2014017116</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">EBLCP</subfield><subfield code="b">eng</subfield><subfield code="e">pn</subfield><subfield code="c">EBLCP</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">YDXCP</subfield><subfield code="d">E7B</subfield><subfield code="d">CCO</subfield><subfield code="d">OCLCO</subfield><subfield code="d">DEBSZ</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">AZK</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">COCUF</subfield><subfield code="d">PIFAG</subfield><subfield code="d">ZCU</subfield><subfield code="d">MERUC</subfield><subfield code="d">DEGRU</subfield><subfield code="d">U3W</subfield><subfield code="d">UIU</subfield><subfield code="d">STF</subfield><subfield code="d">OCLCF</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">ICG</subfield><subfield code="d">VT2</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">WYU</subfield><subfield code="d">OCLCA</subfield><subfield code="d">TKN</subfield><subfield code="d">LEAUB</subfield><subfield code="d">DKC</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">UX1</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">N$T</subfield><subfield code="d">OCLCA</subfield><subfield code="d">K6U</subfield><subfield code="d">U9X</subfield><subfield code="d">VLY</subfield><subfield code="d">AUD</subfield><subfield code="d">BRF</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCL</subfield><subfield code="d">OCLCQ</subfield><subfield code="d">QGK</subfield><subfield code="d">OCLCO</subfield><subfield code="d">OCLCL</subfield><subfield code="d">UEJ</subfield><subfield code="d">OCLCQ</subfield></datafield><datafield tag="019" ind1=" " ind2=" "><subfield code="a">899591384</subfield><subfield code="a">961511398</subfield><subfield code="a">962631912</subfield><subfield code="a">979584791</subfield><subfield code="a">1055394992</subfield><subfield code="a">1066651588</subfield><subfield code="a">1081296984</subfield><subfield code="a">1107345909</subfield><subfield code="a">1162496816</subfield><subfield code="a">1228564800</subfield><subfield code="a">1259054791</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">311028328X</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783110283297</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">3110283298</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783110283280</subfield><subfield code="q">(electronic bk.)</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="z">9783110367645</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="z">3110367645</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">3110381591</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783110381597</subfield></datafield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1515/9783110283280</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)898769669</subfield><subfield code="z">(OCoLC)899591384</subfield><subfield code="z">(OCoLC)961511398</subfield><subfield code="z">(OCoLC)962631912</subfield><subfield code="z">(OCoLC)979584791</subfield><subfield code="z">(OCoLC)1055394992</subfield><subfield code="z">(OCoLC)1066651588</subfield><subfield code="z">(OCoLC)1081296984</subfield><subfield code="z">(OCoLC)1107345909</subfield><subfield code="z">(OCoLC)1162496816</subfield><subfield code="z">(OCoLC)1228564800</subfield><subfield code="z">(OCoLC)1259054791</subfield></datafield><datafield tag="050" ind1=" " ind2="4"><subfield code="a">R853.C55</subfield><subfield code="b">S37 2014eb</subfield></datafield><datafield tag="060" ind1=" " ind2="4"><subfield code="a">W 20.5</subfield></datafield><datafield tag="072" ind1=" " ind2="7"><subfield code="a">MED106000</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="082" ind1="7" ind2=" "><subfield code="a">610.72/4</subfield><subfield code="2">23</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">PZ 4700</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">MAIN</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Schriever, Karl-Heinz.</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">G3P - Good Privacy Protection Practice in Clinical Research :</subfield><subfield code="b">Principles of Pseudonymization and Anonymization.</subfield></datafield><datafield tag="260" ind1=" " ind2=" "><subfield code="a">Berlin/Boston :</subfield><subfield code="b">De Gruyter,</subfield><subfield code="c">2014.</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 online resource (210 pages)</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">computer</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">online resource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="588" ind1="0" ind2=" "><subfield code="a">Print version record.</subfield></datafield><datafield tag="505" ind1="0" ind2=" "><subfield code="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.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="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.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="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.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="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.</subfield></datafield><datafield tag="505" ind1="8" ind2=" "><subfield code="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.</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">17.1 EMA definition of anonymous sample/data.</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="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.</subfield></datafield><datafield tag="504" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references (pages 191-196) and index.</subfield></datafield><datafield tag="546" ind1=" " ind2=" "><subfield code="a">English.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Clinical trials</subfield><subfield code="x">Research.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Data protection.</subfield><subfield code="0">http://id.loc.gov/authorities/subjects/sh85035859</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Medical care</subfield><subfield code="x">Research.</subfield><subfield code="0">http://id.loc.gov/authorities/subjects/sh85082882</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Medical records</subfield><subfield code="x">Access control.</subfield><subfield code="0">http://id.loc.gov/authorities/subjects/sh85083012</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Privacy, Right of.</subfield><subfield code="0">http://id.loc.gov/authorities/subjects/sh85107029</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Confidential communications.</subfield><subfield code="0">http://id.loc.gov/authorities/subjects/sh85030929</subfield></datafield><datafield tag="650" ind1="1" ind2="2"><subfield code="a">Biomedical Research</subfield></datafield><datafield tag="650" ind1="2" ind2="2"><subfield code="a">Anonymous Testing</subfield></datafield><datafield tag="650" ind1="2" ind2="2"><subfield code="a">Confidentiality</subfield></datafield><datafield tag="650" ind1="2" ind2="2"><subfield code="a">Privacy</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Études cliniques</subfield><subfield code="x">Recherche.</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Protection de l'information (Informatique)</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Soins médicaux</subfield><subfield code="x">Recherche.</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Dossiers médicaux</subfield><subfield code="x">Accès</subfield><subfield code="x">Contrôle.</subfield></datafield><datafield tag="650" ind1=" " ind2="6"><subfield code="a">Secret professionnel.</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">MEDICAL / Research.</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Confidential communications</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Data protection</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Medical care</subfield><subfield code="x">Research</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Medical records</subfield><subfield code="x">Access control</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Privacy, Right of</subfield><subfield code="2">fast</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Medizin</subfield><subfield code="2">gnd</subfield><subfield code="0">http://d-nb.info/gnd/4038243-6</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">Datenschutz</subfield><subfield code="2">gnd</subfield><subfield code="0">http://d-nb.info/gnd/4011134-9</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Schröder, Markus.</subfield></datafield><datafield tag="758" ind1=" " ind2=" "><subfield code="i">has work:</subfield><subfield code="a">G3P (Text)</subfield><subfield code="1">https://id.oclc.org/worldcat/entity/E39PCFtqFWpdVC4gr7ybr4fpfq</subfield><subfield code="4">https://id.oclc.org/worldcat/ontology/hasWork</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Print version:</subfield><subfield code="a">Schriever, Karl-Heinz.</subfield><subfield code="t">G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization.</subfield><subfield code="d">Berlin/Boston : De Gruyter, ©2014</subfield><subfield code="z">9783110367645</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="l">FWS01</subfield><subfield code="p">ZDB-4-EBA</subfield><subfield code="q">FWS_PDA_EBA</subfield><subfield code="u">https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=909994</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="936" ind1=" " ind2=" "><subfield code="a">BATCHLOAD</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">De Gruyter</subfield><subfield code="b">DEGR</subfield><subfield code="n">9783110283280</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">EBL - Ebook Library</subfield><subfield code="b">EBLB</subfield><subfield code="n">EBL1685362</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">ebrary</subfield><subfield code="b">EBRY</subfield><subfield code="n">ebr11006632</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">YBP Library Services</subfield><subfield code="b">YANK</subfield><subfield code="n">11725008</subfield></datafield><datafield tag="938" ind1=" " ind2=" "><subfield code="a">EBSCOhost</subfield><subfield code="b">EBSC</subfield><subfield code="n">909994</subfield></datafield><datafield tag="994" ind1=" " ind2=" "><subfield code="a">92</subfield><subfield code="b">GEBAY</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-4-EBA</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-863</subfield></datafield></record></collection> |
| id | ZDB-4-EBA-ocn898769669 |
| illustrated | Not Illustrated |
| indexdate | 2024-11-27T13:26:23Z |
| institution | BVB |
| isbn | 311028328X 9783110283297 3110283298 9783110283280 3110381591 9783110381597 |
| language | English |
| lccn | 2014017116 |
| oclc_num | 898769669 |
| open_access_boolean | |
| owner | MAIN DE-863 DE-BY-FWS |
| owner_facet | MAIN DE-863 DE-BY-FWS |
| physical | 1 online resource (210 pages) |
| psigel | ZDB-4-EBA |
| publishDate | 2014 |
| publishDateSearch | 2014 |
| publishDateSort | 2014 |
| publisher | De Gruyter, |
| record_format | marc |
| spelling | Schriever, Karl-Heinz. G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. Berlin/Boston : De Gruyter, 2014. 1 online resource (210 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Print version record. 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. 17.1 EMA definition of anonymous sample/data. 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. Includes bibliographical references (pages 191-196) and index. English. Clinical trials Research. Data protection. http://id.loc.gov/authorities/subjects/sh85035859 Medical care Research. http://id.loc.gov/authorities/subjects/sh85082882 Medical records Access control. http://id.loc.gov/authorities/subjects/sh85083012 Privacy, Right of. http://id.loc.gov/authorities/subjects/sh85107029 Confidential communications. http://id.loc.gov/authorities/subjects/sh85030929 Biomedical Research Anonymous Testing Confidentiality Privacy Études cliniques Recherche. Protection de l'information (Informatique) Soins médicaux Recherche. Dossiers médicaux Accès Contrôle. Secret professionnel. MEDICAL / Research. bisacsh Confidential communications fast Data protection fast Medical care Research fast Medical records Access control fast Privacy, Right of fast Medizin gnd http://d-nb.info/gnd/4038243-6 Datenschutz gnd http://d-nb.info/gnd/4011134-9 Schröder, Markus. has work: G3P (Text) https://id.oclc.org/worldcat/entity/E39PCFtqFWpdVC4gr7ybr4fpfq https://id.oclc.org/worldcat/ontology/hasWork Print version: Schriever, Karl-Heinz. G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. Berlin/Boston : De Gruyter, ©2014 9783110367645 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=909994 Volltext |
| spellingShingle | Schriever, Karl-Heinz G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. 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. Clinical trials Research. Data protection. http://id.loc.gov/authorities/subjects/sh85035859 Medical care Research. http://id.loc.gov/authorities/subjects/sh85082882 Medical records Access control. http://id.loc.gov/authorities/subjects/sh85083012 Privacy, Right of. http://id.loc.gov/authorities/subjects/sh85107029 Confidential communications. http://id.loc.gov/authorities/subjects/sh85030929 Biomedical Research Anonymous Testing Confidentiality Privacy Études cliniques Recherche. Protection de l'information (Informatique) Soins médicaux Recherche. Dossiers médicaux Accès Contrôle. Secret professionnel. MEDICAL / Research. bisacsh Confidential communications fast Data protection fast Medical care Research fast Medical records Access control fast Privacy, Right of fast Medizin gnd http://d-nb.info/gnd/4038243-6 Datenschutz gnd http://d-nb.info/gnd/4011134-9 |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85035859 http://id.loc.gov/authorities/subjects/sh85082882 http://id.loc.gov/authorities/subjects/sh85083012 http://id.loc.gov/authorities/subjects/sh85107029 http://id.loc.gov/authorities/subjects/sh85030929 http://d-nb.info/gnd/4038243-6 http://d-nb.info/gnd/4011134-9 |
| 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. |
| title_fullStr | G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. |
| title_full_unstemmed | G3P - Good Privacy Protection Practice in Clinical Research : Principles of Pseudonymization and Anonymization. |
| 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 | Clinical trials Research. Data protection. http://id.loc.gov/authorities/subjects/sh85035859 Medical care Research. http://id.loc.gov/authorities/subjects/sh85082882 Medical records Access control. http://id.loc.gov/authorities/subjects/sh85083012 Privacy, Right of. http://id.loc.gov/authorities/subjects/sh85107029 Confidential communications. http://id.loc.gov/authorities/subjects/sh85030929 Biomedical Research Anonymous Testing Confidentiality Privacy Études cliniques Recherche. Protection de l'information (Informatique) Soins médicaux Recherche. Dossiers médicaux Accès Contrôle. Secret professionnel. MEDICAL / Research. bisacsh Confidential communications fast Data protection fast Medical care Research fast Medical records Access control fast Privacy, Right of fast Medizin gnd http://d-nb.info/gnd/4038243-6 Datenschutz gnd http://d-nb.info/gnd/4011134-9 |
| topic_facet | Clinical trials Research. Data protection. Medical care Research. Medical records Access control. Privacy, Right of. Confidential communications. Biomedical Research Anonymous Testing Confidentiality Privacy Études cliniques Recherche. Protection de l'information (Informatique) Soins médicaux Recherche. Dossiers médicaux Accès Contrôle. Secret professionnel. MEDICAL / Research. Confidential communications Data protection Medical care Research Medical records Access control Privacy, Right of Medizin Datenschutz |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=909994 |
| work_keys_str_mv | AT schrieverkarlheinz g3pgoodprivacyprotectionpracticeinclinicalresearchprinciplesofpseudonymizationandanonymization AT schrodermarkus g3pgoodprivacyprotectionpracticeinclinicalresearchprinciplesofpseudonymizationandanonymization |