06258oam 22012134a 450 991083055350332120230829003321.01-280-55482-797866105548290-470-32599-20-470-84626-7(CKB)111004366694272(MH)011321923-7(SSID)ssj0000128444(PQKBManifestationID)11139631(PQKBTitleCode)TC0000128444(PQKBWorkID)10064842(PQKB)10565129(MiAaPQ)EBC4956583(Au-PeEL)EBL4956583(CaONFJC)MIL55482(OCoLC)824553387(EXLCZ)9911100436669427219981208d1999 uy 0engurcnu||||||||txtccrConducting GCP-compliant clinical research /Wendy Bohaychuk and Graham Ball[electronic resource]Chichester ;New York John Wileyc19991 online resource (xiv, 211 p. )Bibliographic Level Mode of Issuance: Monograph0-470-84253-9 0-471-98824-3 Includes bibliographical references (p. 202-205) and index.Conducting 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 investigatorsensure 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.Clinical trialsStandardsDrugsTestingStandardsOnderzoekgttGeneeskundegttClinical Trials as TopicstandardsDrug EvaluationstandardsDrug Evaluation, PreclinicalEvaluation Studies as TopicDrug DiscoveryInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CarePublic HealthEnvironment and Public HealthHealth Care Quality, Access, and EvaluationHealth CareClinical Trials as TopicDrug Evaluation, PreclinicalDrug EvaluationMedicineHILCCHealth & Biological SciencesHILCCMedical ResearchHILCCComputer network resources.localElectronic books.lcshClinical trialsStandards.DrugsTestingStandards.Onderzoek.Geneeskunde.Clinical Trials as Topicstandards.Drug Evaluationstandards.Drug Evaluation, Preclinical.Evaluation Studies as TopicDrug DiscoveryInvestigative TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CarePublic HealthEnvironment and Public HealthHealth Care Quality, Access, and EvaluationHealth CareClinical Trials as TopicDrug Evaluation, PreclinicalDrug EvaluationMedicineHealth & Biological SciencesMedical Research615/.1901Bohaychuk Wendy1646619Ball Graham1646620John Wiley & Sons.DLCDLCC#PUKMNLMBAKERNLGGCBTCTAYDXCPBOOK9910830553503321Conducting GCP-compliant clinical research3993721UNINAThis 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