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GCP auditing: methods and experiences

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Bibliographic Details
Format:	Book
Language:	English
Published:	Aulendorf ECV, Editio-Cantor-Verl. 2007
Edition:	2., rev. and expanded ed.
Series:	pharmind-Serie Dokumentation
Subjects:	Clinical Trials as Topic Financial Audit > methods Pharmaceutical Preparations Quality Control Total Quality Management GCP-Regeln Klinische Prüfung
Online Access:	Inhaltsverzeichnis Auszug Inhaltstext Inhaltsverzeichnis Klappentext
Item Description:	Literaturangaben
Physical Description:	287 S. 21 cm
ISBN:	9783871933561 3871933562

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MARC


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Record in the Search Index

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adam_text	Contents Key Note Address Gabriele Schwarz 7 Preface for the 1st edition Hans Günther Stelzer 9 Preface for the 2nd edition Hans Günther Stelzer 10 Quality Management in Clinical Research and the Value of Audits Rita Hattemer-Apostel 11 Clinical Quality Management in a Medical Department of a Multinational Pharmaceutical Company - an Enhanced Approach to Quality Jürgen-Hans Schmidt, Martin Gebauer, and Thorsten Gorbauch 33 Audit Schedule and Project Auditor in a Clinical Project Eva Beate Ansmann, Ilona Fleischhauer, Jürgen-Hans Schmidt, Christine Korbmacher, and Christiane Ehmer 41 Audit of Protocol, Written Information for Study Participants, Informed Consent Form and Case Report Form Wolfgang Krempien and Roland Scharpf 48 The Investigator Site Audit Carmen Julius, Beat Widler, Elfriede Lindauer, and Friederike Spengler 61 Clinical Investigator Audit as Part of the Systems Audit Beat Widler, Elfriede Lindauer, Carmen Julius, and Friederike Spengler 71 Investigator Site Audits by the Sponsor in CRO-Monitored Studies Jürgen-Hans Schmidt and Martin Gebauer 77 Sponsor Audits at Contract Research Organisations (CROs) - the CROs' Perspective Dagmar Chase and Jürgen-Hans Schmidt 82 5 Sponsor Audits at Contract Research Organisations (CROs) - the Sponsors' Perspective Jürgen-Hans Schmidt and Dagmar Chase "" Audit in the Analytical Laboratory Ralf Schaltenbrand, Susanne Plate, Volker El-Samalouti, and Karin Reimeisen 109 Audits of Specialised Laboratories: Approaches, Problems and Solutions Andreas Edelmann and Michaela Rittberger 124 Audits of Early Phase Clinical Trials and Clinical Pharmacology Units Rita Hattemer-Apostel and John Norton 14Ò Systems Audits in Pharmacovigilance Michaela Rittberger, Michael Stegemann, and Jürgen-Hans Schmidt ' 64 Audits in Data Management, Statistics and Medical Writing: Auditing Clinical Databases, Trial Reports and Related Systems Rita Hattemer-Apostel and Wolfgang Reinhardt 188 Validation of Computer Systems in Clinical Trials Peter M. Kaiser, Per-Holger Sanden, and Thomas Badautschek 206 Electronic Data Capture (EDC) in Clinical Trials from a Quality Assurance Perspective Hans Poland 219 Performing and Reporting an Audit - Administrative and Technical Aspects Beat Widler, Iris Sobol, and Rudolf Löffel 247 Appendix Acronyms and Abbreviations 259 Glossary 263 Index 283 Authors' Addresses 285 The second edition of this handbook provides again a comprehensive and up-to-date description of the audit¬ ing methods and activities that accompany today's clini¬ cal development. All chapters have been revised, new chapters have been added. The subjects cover audits of the written information for investigators and study par¬ ticipants, phase I audits, investigator site audits, CRO audits, and systems audits. It provides worthwhile reading for clinical operations professionals and quality manage¬ ment experts involved in drag research and development, who want to get an overview of the clinical auditing pro¬ cess, as well as for those, who want to widen their scope.
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bvnumber	BV035468233
ctrlnum	(OCoLC)244264544 (DE-599)DNB985289317
dewey-full	615.580724
dewey-hundreds	600 - Technology (Applied sciences)
dewey-ones	615 - Pharmacology and therapeutics
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dewey-tens	610 - Medicine and health
discipline	Medizin
edition	2., rev. and expanded ed.
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physical	287 S. 21 cm
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spelling	GCP auditing methods and experiences ed. by the German Society for Good Research Practice (DGGF) 2., rev. and expanded ed. Aulendorf ECV, Editio-Cantor-Verl. 2007 287 S. 21 cm txt rdacontent n rdamedia nc rdacarrier pharmind-Serie Dokumentation Literaturangaben Clinical Trials as Topic Financial Audit methods Pharmaceutical Preparations Quality Control Total Quality Management GCP-Regeln (DE-588)4281617-8 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 gnd rswk-swf Klinische Prüfung (DE-588)4031192-2 s GCP-Regeln (DE-588)4281617-8 s DE-604 Deutsche Gesellschaft für Gute Forschungspraxis Sonstige (DE-588)3057304-X oth application/pdf http://www.ecv.de/ecv/catalog/inhalt/3871933562_Inhaltsverzeichnis.pdf Inhaltsverzeichnis application/pdf http://www.ecv.de/ecv/catalog/leseproben/3871933562_Leseprobe.pdf Auszug text/html http://deposit.dnb.de/cgi-bin/dokserv?id=2992949&prov=M&dok_var=1&dok_ext=htm Inhaltstext Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017387951&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017387951&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext
spellingShingle	GCP auditing methods and experiences Clinical Trials as Topic Financial Audit methods Pharmaceutical Preparations Quality Control Total Quality Management GCP-Regeln (DE-588)4281617-8 gnd Klinische Prüfung (DE-588)4031192-2 gnd
subject_GND	(DE-588)4281617-8 (DE-588)4031192-2
title	GCP auditing methods and experiences
title_auth	GCP auditing methods and experiences
title_exact_search	GCP auditing methods and experiences
title_full	GCP auditing methods and experiences ed. by the German Society for Good Research Practice (DGGF)
title_fullStr	GCP auditing methods and experiences ed. by the German Society for Good Research Practice (DGGF)
title_full_unstemmed	GCP auditing methods and experiences ed. by the German Society for Good Research Practice (DGGF)
title_short	GCP auditing
title_sort	gcp auditing methods and experiences
title_sub	methods and experiences
topic	Clinical Trials as Topic Financial Audit methods Pharmaceutical Preparations Quality Control Total Quality Management GCP-Regeln (DE-588)4281617-8 gnd Klinische Prüfung (DE-588)4031192-2 gnd
topic_facet	Clinical Trials as Topic Financial Audit methods Pharmaceutical Preparations Quality Control Total Quality Management GCP-Regeln Klinische Prüfung
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