Clinical trials audit preparation: a guide for good clinical practice (GCP) inspections
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
Wiley
c2010
|
| Schlagworte: | |
| Online-Zugang: | TUM01 Volltext |
| Beschreibung: | Good clinical practice and therapeutic product development -- Therapeutic products clinical development in the United States -- The inspection preparation -- Analysis of warning letters -- Fraud and misconduct in clinical research -- Appendix A: some answers to the most problematic questions in compliance -- Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance -- Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects -- Appendix D: Nuremberg Code -- Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research Includes bibliographical references and index |
| Beschreibung: | 1 Online-Ressource (xxi, 246 p.) |
| ISBN: | 0470572744 0470572752 9780470572740 9780470572757 |
Internformat
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| 100 | 1 | |a Mihajlovic-Madzarevic, Vera |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Clinical trials audit preparation |b a guide for good clinical practice (GCP) inspections |c Vera Mihajlovic-Madzarevic |
| 264 | 1 | |a Hoboken, N.J. |b Wiley |c c2010 | |
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| 500 | |a Good clinical practice and therapeutic product development -- Therapeutic products clinical development in the United States -- The inspection preparation -- Analysis of warning letters -- Fraud and misconduct in clinical research -- Appendix A: some answers to the most problematic questions in compliance -- Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance -- Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects -- Appendix D: Nuremberg Code -- Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research | ||
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Clinical Trials as Topic / standards | |
| 650 | 4 | |a Guideline Adherence / standards | |
| 650 | 4 | |a Management Audit | |
| 650 | 4 | |a Quality Control | |
| 650 | 7 | |a MEDICAL / Chemotherapy |2 bisacsh | |
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Drugs / Testing / Auditing | |
| 650 | 4 | |a Medical audit | |
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Datensatz im Suchindex
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| any_adam_object | |
| author | Mihajlovic-Madzarevic, Vera |
| author_facet | Mihajlovic-Madzarevic, Vera |
| author_role | aut |
| author_sort | Mihajlovic-Madzarevic, Vera |
| author_variant | v m m vmm |
| building | Verbundindex |
| bvnumber | BV041049579 |
| collection | ZDB-4-NLEBK |
| ctrlnum | (OCoLC)654804300 (DE-599)BVBBV041049579 |
| dewey-full | 615.5/80724 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.5/80724 |
| dewey-search | 615.5/80724 |
| dewey-sort | 3615.5 580724 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Electronic eBook |
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| id | DE-604.BV041049579 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T00:38:33Z |
| institution | BVB |
| isbn | 0470572744 0470572752 9780470572740 9780470572757 |
| language | English |
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| physical | 1 Online-Ressource (xxi, 246 p.) |
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| publisher | Wiley |
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| spelling | Mihajlovic-Madzarevic, Vera Verfasser aut Clinical trials audit preparation a guide for good clinical practice (GCP) inspections Vera Mihajlovic-Madzarevic Hoboken, N.J. Wiley c2010 1 Online-Ressource (xxi, 246 p.) txt rdacontent c rdamedia cr rdacarrier Good clinical practice and therapeutic product development -- Therapeutic products clinical development in the United States -- The inspection preparation -- Analysis of warning letters -- Fraud and misconduct in clinical research -- Appendix A: some answers to the most problematic questions in compliance -- Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance -- Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects -- Appendix D: Nuremberg Code -- Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research Includes bibliographical references and index Clinical Trials as Topic / standards Guideline Adherence / standards Management Audit Quality Control MEDICAL / Chemotherapy bisacsh Medizin Drugs / Testing / Auditing Medical audit Erscheint auch als Druck-Ausgabe, Hardcover 0-470-24885-8 Erscheint auch als Druck-Ausgabe, Hardcover 978-0-470-24885-0 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636 Verlag Volltext |
| spellingShingle | Mihajlovic-Madzarevic, Vera Clinical trials audit preparation a guide for good clinical practice (GCP) inspections Clinical Trials as Topic / standards Guideline Adherence / standards Management Audit Quality Control MEDICAL / Chemotherapy bisacsh Medizin Drugs / Testing / Auditing Medical audit |
| title | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections |
| title_auth | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections |
| title_exact_search | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections |
| title_full | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections Vera Mihajlovic-Madzarevic |
| title_fullStr | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections Vera Mihajlovic-Madzarevic |
| title_full_unstemmed | Clinical trials audit preparation a guide for good clinical practice (GCP) inspections Vera Mihajlovic-Madzarevic |
| title_short | Clinical trials audit preparation |
| title_sort | clinical trials audit preparation a guide for good clinical practice gcp inspections |
| title_sub | a guide for good clinical practice (GCP) inspections |
| topic | Clinical Trials as Topic / standards Guideline Adherence / standards Management Audit Quality Control MEDICAL / Chemotherapy bisacsh Medizin Drugs / Testing / Auditing Medical audit |
| topic_facet | Clinical Trials as Topic / standards Guideline Adherence / standards Management Audit Quality Control MEDICAL / Chemotherapy Medizin Drugs / Testing / Auditing Medical audit |
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