Clinical trials audit preparation: a guide for good clinical practice (GCP) inspections
Saved in:
| Main Author: | |
|---|---|
| Format: | Electronic eBook |
| Language: | English |
| Published: |
Hoboken, N.J.
Wiley
c2010
|
| Subjects: | |
| Online Access: | TUM01 Volltext |
| Item Description: | 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 |
| Physical Description: | 1 Online-Ressource (xxi, 246 p.) |
| ISBN: | 0470572744 0470572752 9780470572740 9780470572757 |
Staff View
MARC
| LEADER | 00000nmm a2200000zc 4500 | ||
|---|---|---|---|
| 001 | BV041049579 | ||
| 003 | DE-604 | ||
| 005 | 20150527 | ||
| 007 | cr|uuu---uuuuu | ||
| 008 | 130528s2010 |||| o||u| ||||||eng d | ||
| 020 | |a 0470572744 |c electronic bk. |9 0-470-57274-4 | ||
| 020 | |a 0470572752 |c electronic bk. |9 0-470-57275-2 | ||
| 020 | |a 9780470572740 |c electronic bk. |9 978-0-470-57274-0 | ||
| 020 | |a 9780470572757 |c electronic bk. |9 978-0-470-57275-7 | ||
| 035 | |a (OCoLC)654804300 | ||
| 035 | |a (DE-599)BVBBV041049579 | ||
| 040 | |a DE-604 |b ger |e aacr | ||
| 041 | 0 | |a eng | |
| 049 | |a DE-91 | ||
| 082 | 0 | |a 615.5/80724 |2 22 | |
| 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 | |
| 300 | |a 1 Online-Ressource (xxi, 246 p.) | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b c |2 rdamedia | ||
| 338 | |b cr |2 rdacarrier | ||
| 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 | |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe, Hardcover |z 0-470-24885-8 |
| 776 | 0 | 8 | |i Erscheint auch als |n Druck-Ausgabe, Hardcover |z 978-0-470-24885-0 |
| 856 | 4 | 0 | |u http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636 |x Verlag |3 Volltext |
| 912 | |a ZDB-4-NLEBK | ||
| 999 | |a oai:aleph.bib-bvb.de:BVB01-026026837 | ||
| 966 | e | |u http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636 |l TUM01 |p ZDB-4-NLEBK |q TUM_PDA_EBSCO_MED_gekauft |x Verlag |3 Volltext | |
Record in the Search Index
| _version_ | 1804150414300413952 |
|---|---|
| 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 |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>02573nmm a2200481zc 4500</leader><controlfield tag="001">BV041049579</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20150527 </controlfield><controlfield tag="007">cr|uuu---uuuuu</controlfield><controlfield tag="008">130528s2010 |||| o||u| ||||||eng d</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0470572744</subfield><subfield code="c">electronic bk.</subfield><subfield code="9">0-470-57274-4</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">0470572752</subfield><subfield code="c">electronic bk.</subfield><subfield code="9">0-470-57275-2</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9780470572740</subfield><subfield code="c">electronic bk.</subfield><subfield code="9">978-0-470-57274-0</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9780470572757</subfield><subfield code="c">electronic bk.</subfield><subfield code="9">978-0-470-57275-7</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)654804300</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)BVBBV041049579</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">aacr</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-91</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">615.5/80724</subfield><subfield code="2">22</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Mihajlovic-Madzarevic, Vera</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Clinical trials audit preparation</subfield><subfield code="b">a guide for good clinical practice (GCP) inspections</subfield><subfield code="c">Vera Mihajlovic-Madzarevic</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Hoboken, N.J.</subfield><subfield code="b">Wiley</subfield><subfield code="c">c2010</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource (xxi, 246 p.)</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="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</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references and index</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Clinical Trials as Topic / standards</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Guideline Adherence / standards</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Management Audit</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality Control</subfield></datafield><datafield tag="650" ind1=" " ind2="7"><subfield code="a">MEDICAL / Chemotherapy</subfield><subfield code="2">bisacsh</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medizin</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Drugs / Testing / Auditing</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical audit</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe, Hardcover</subfield><subfield code="z">0-470-24885-8</subfield></datafield><datafield tag="776" ind1="0" ind2="8"><subfield code="i">Erscheint auch als</subfield><subfield code="n">Druck-Ausgabe, Hardcover</subfield><subfield code="z">978-0-470-24885-0</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-4-NLEBK</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-026026837</subfield></datafield><datafield tag="966" ind1="e" ind2=" "><subfield code="u">http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636</subfield><subfield code="l">TUM01</subfield><subfield code="p">ZDB-4-NLEBK</subfield><subfield code="q">TUM_PDA_EBSCO_MED_gekauft</subfield><subfield code="x">Verlag</subfield><subfield code="3">Volltext</subfield></datafield></record></collection> |
| id | DE-604.BV041049579 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T00:38:33Z |
| institution | BVB |
| isbn | 0470572744 0470572752 9780470572740 9780470572757 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-026026837 |
| oclc_num | 654804300 |
| open_access_boolean | |
| owner | DE-91 DE-BY-TUM |
| owner_facet | DE-91 DE-BY-TUM |
| physical | 1 Online-Ressource (xxi, 246 p.) |
| psigel | ZDB-4-NLEBK ZDB-4-NLEBK TUM_PDA_EBSCO_MED_gekauft |
| publishDate | 2010 |
| publishDateSearch | 2010 |
| publishDateSort | 2010 |
| publisher | Wiley |
| record_format | marc |
| 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 |
| url | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=535636 |
| work_keys_str_mv | AT mihajlovicmadzarevicvera clinicaltrialsauditpreparationaguideforgoodclinicalpracticegcpinspections |