LEADER 04039nam 2200721 450 001 9910815917103321 005 20230803200437.0 010 $a3-11-028328-X 010 $a3-11-038159-1 024 7 $a10.1515/9783110283280 035 $a(CKB)3360000000515420 035 $a(EBL)1685362 035 $a(SSID)ssj0001424084 035 $a(PQKBManifestationID)12626296 035 $a(PQKBTitleCode)TC0001424084 035 $a(PQKBWorkID)11441082 035 $a(PQKB)10313852 035 $a(MiAaPQ)EBC1685362 035 $a(DE-B1597)427829 035 $a(OCoLC)898769669 035 $a(OCoLC)979584791 035 $a(DE-B1597)9783110283280 035 $a(Au-PeEL)EBL1685362 035 $a(CaPaEBR)ebr11006632 035 $a(CaONFJC)MIL807291 035 $a(EXLCZ)993360000000515420 100 $a20140430h20142014 uy| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aG3P $egood privacy protection practice in clinical research : principles of pseudonymization and anonymization /$fKarl-Heinz Schriever, Markus Schro?der 210 1$aBerlin ;$aNew York :$cDe Gruyter,$d[2014] 210 4$dİ2014 215 $a1 online resource (210 p.) 300 $aDescription based upon print version of record. 311 $a3-11-055436-4 311 $a3-11-036764-5 320 $aIncludes bibliographical references (pages [191]-196) and index. 327 $aStudy modes -- Protection masks and procedures -- Coding methods for de-identified samples/data -- Relationships among the protection masks -- Data types -- Anonymization -- Validation : a brief introduction -- Request management -- Legal requirements & regulations -- Informed consent -- Selected data protection & medical sites -- Impact of external services on data protection -- Practical approach to clinical trials with supplementary genetic parts. 330 $aEstablishing 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. 606 $aClinical trials$xResearch 606 $aData protection 606 $aMedical care$xResearch 606 $aMedical records$xAccess control 606 $aPrivacy, Right of 615 0$aClinical trials$xResearch. 615 0$aData protection. 615 0$aMedical care$xResearch. 615 0$aMedical records$xAccess control. 615 0$aPrivacy, Right of. 676 $a610.72/4 686 $aPZ 4700$2rvk 700 $aSchriever$b K.-H.$f1948-$01685395 702 $aSchro?der$b Markus$f1960- 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910815917103321 996 $aG3P$94057494 997 $aUNINA