GCP auditing: methods and experiences
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Aulendorf
ECV, Editio-Cantor-Verl.
2007
|
| Ausgabe: | 2., rev. and expanded ed. |
| Schriftenreihe: | pharmind-Serie Dokumentation
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Auszug Inhaltstext Inhaltsverzeichnis Klappentext |
| Beschreibung: | Literaturangaben |
| Beschreibung: | 287 S. 21 cm |
| ISBN: | 9783871933561 3871933562 |
Internformat
MARC
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Datensatz im Suchindex
| _version_ | 1805092286740037632 |
|---|---|
| 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. |
| any_adam_object | 1 |
| building | Verbundindex |
| bvnumber | BV035468233 |
| ctrlnum | (OCoLC)244264544 (DE-599)DNB985289317 |
| dewey-full | 615.580724 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.580724 |
| dewey-search | 615.580724 |
| dewey-sort | 3615.580724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | 2., rev. and expanded ed. |
| format | Book |
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| illustrated | Not Illustrated |
| indexdate | 2024-07-20T10:09:10Z |
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| isbn | 9783871933561 3871933562 |
| language | English |
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| physical | 287 S. 21 cm |
| publishDate | 2007 |
| publishDateSearch | 2007 |
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| publisher | ECV, Editio-Cantor-Verl. |
| record_format | marc |
| series2 | pharmind-Serie Dokumentation |
| 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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