LEADER 06254oam 22012134a 450 001 9910841079503321 005 20230829003321.0 010 $a1-280-55482-7 010 $a9786610554829 010 $a0-470-32599-2 010 $a0-470-84626-7 035 $a(CKB)111004366694272 035 $a(MH)011321923-7 035 $a(SSID)ssj0000128444 035 $a(PQKBManifestationID)11139631 035 $a(PQKBTitleCode)TC0000128444 035 $a(PQKBWorkID)10064842 035 $a(PQKB)10565129 035 $a(MiAaPQ)EBC4956583 035 $a(Au-PeEL)EBL4956583 035 $a(CaONFJC)MIL55482 035 $a(OCoLC)824553387 035 $a(EXLCZ)99111004366694272 100 $a19981208d1999 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aConducting GCP-compliant clinical research /$fWendy Bohaychuk and Graham Ball$b[electronic resource] 210 $aChichester ;$aNew York $cJohn Wiley$dc1999 215 $a1 online resource (xiv, 211 p. ) 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-470-84253-9 311 $a0-471-98824-3 320 $aIncludes bibliographical references (p. 202-205) and index. 330 $aConducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including: Standard operating procedures for investigators Standard operating procedures for sponsors and CROs GCP - an indexed reference Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels.; Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators 330 8 $aensure that nothing important is overlooked.; The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies. 606 $aClinical trials$xStandards 606 $aDrugs$xTesting$xStandards 606 $aOnderzoek$2gtt 606 $aGeneeskunde$2gtt 606 $aClinical Trials as Topic$xstandards 606 $aDrug Evaluation$xstandards 606 $aDrug Evaluation, Preclinical 606 $aEvaluation Studies as Topic 606 $aDrug Discovery 606 $aInvestigative Techniques 606 $aEpidemiologic Methods 606 $aHealth Care Evaluation Mechanisms 606 $aQuality of Health Care 606 $aPublic Health 606 $aEnvironment and Public Health 606 $aHealth Care Quality, Access, and Evaluation 606 $aHealth Care 606 $aClinical Trials as Topic 606 $aDrug Evaluation, Preclinical 606 $aDrug Evaluation 606 $aMedicine$2HILCC 606 $aHealth & Biological Sciences$2HILCC 606 $aMedical Research$2HILCC 608 $aComputer network resources.$2local 608 $aElectronic books.$2lcsh 615 0$aClinical trials$xStandards. 615 0$aDrugs$xTesting$xStandards. 615 17$aOnderzoek. 615 17$aGeneeskunde. 615 12$aClinical Trials as Topic$xstandards. 615 22$aDrug Evaluation$xstandards. 615 22$aDrug Evaluation, Preclinical. 615 2$aEvaluation Studies as Topic 615 2$aDrug Discovery 615 2$aInvestigative Techniques 615 2$aEpidemiologic Methods 615 2$aHealth Care Evaluation Mechanisms 615 2$aQuality of Health Care 615 2$aPublic Health 615 2$aEnvironment and Public Health 615 2$aHealth Care Quality, Access, and Evaluation 615 2$aHealth Care 615 2$aClinical Trials as Topic 615 2$aDrug Evaluation, Preclinical 615 2$aDrug Evaluation 615 7$aMedicine 615 7$aHealth & Biological Sciences 615 7$aMedical Research 676 $a615/.1901 700 $aBohaychuk$b Wendy$01729395 701 $aBall$b Graham$01729396 712 02$aJohn Wiley & Sons. 801 0$bDLC 801 1$bDLC 801 2$bC#P 801 2$bUKM 801 2$bNLM 801 2$bBAKER 801 2$bNLGGC 801 2$bBTCTA 801 2$bYDXCP 906 $aBOOK 912 $a9910841079503321 996 $aConducting GCP-compliant clinical research$94139176 997 $aUNINA 999 $aThis Record contains information from the Harvard Library Bibliographic Dataset, which is provided by the Harvard Library under its Bibliographic Dataset Use Terms and includes data made available by, among others the Library of Congress