Assuring data quality and validity in clinical trials for regulatory decision making :: workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices /
Gespeichert in:
| Körperschaft: | |
|---|---|
| Weitere Verfasser: | |
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Washington, DC :
National Academy Press,
©1999.
|
| Schriftenreihe: | Compass series (Washington, D.C.)
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Beschreibung: | 1 online resource (xii, 76 pages) : illustrations |
| Bibliographie: | Includes bibliographical references (pages 75-76). |
| ISBN: | 0585142610 9780585142616 030952024X 9780309520249 |
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| 245 | 0 | 0 | |a Assuring data quality and validity in clinical trials for regulatory decision making : |b workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / |c Jonathan R. Davis [and others] editors. |
| 260 | |a Washington, DC : |b National Academy Press, |c ©1999. | ||
| 300 | |a 1 online resource (xii, 76 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
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| 338 | |a online resource |b cr |2 rdacarrier | ||
| 347 | |a data file | ||
| 490 | 1 | |a The compass series | |
| 504 | |a Includes bibliographical references (pages 75-76). | ||
| 505 | 0 | |a Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices. | |
| 588 | 0 | |a Print version record. | |
| 546 | |a English. | ||
| 610 | 1 | 0 | |a United States. |b Food and Drug Administration. |
| 610 | 1 | 7 | |a United States. |b Food and Drug Administration |2 fast |
| 650 | 0 | |a Clinical trials |x Quality control. | |
| 650 | 0 | |a Clinical trials |x Data processing |v Congresses. | |
| 650 | 0 | |a Decision making. |0 http://id.loc.gov/authorities/subjects/sh85036199 | |
| 650 | 0 | |a Quality control. |0 http://id.loc.gov/authorities/subjects/sh85109440 | |
| 650 | 2 | |a United States Food and Drug Administration | |
| 650 | 1 | 2 | |a Clinical Trials |x standards |
| 650 | 2 | 2 | |a Decision Making |0 https://id.nlm.nih.gov/mesh/D003657 |
| 650 | 2 | 2 | |a Quality Control |0 https://id.nlm.nih.gov/mesh/D011786 |
| 650 | 2 | 2 | |a Research Design |0 https://id.nlm.nih.gov/mesh/D012107 |
| 650 | 6 | |a Études cliniques |x Qualité |x Contrôle. | |
| 650 | 6 | |a Études cliniques |x Informatique |v Congrès. | |
| 650 | 6 | |a Prise de décision. | |
| 650 | 6 | |a Qualité |x Contrôle. | |
| 650 | 7 | |a decision making. |2 aat | |
| 650 | 7 | |a quality control. |2 aat | |
| 650 | 7 | |a MEDICAL |x Drug Guides. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Nursing |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Pharmacy. |2 bisacsh | |
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| 650 | 7 | |a Decision making |2 fast | |
| 650 | 7 | |a Clinical trials |x Data processing |2 fast | |
| 653 | |a Andre fag (naturvidenskab og teknik) |a Andre fag. | ||
| 655 | 0 | |a Electronic books. | |
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| 655 | 7 | |a Actes de congrès. |2 rvmgf | |
| 700 | 1 | |a Davis, Jonathan R. |0 http://id.loc.gov/authorities/names/n00010006 | |
| 710 | 2 | |a Institute of Medicine (U.S.). |b Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. |0 http://id.loc.gov/authorities/names/no99081645 | |
| 758 | |i has work: |a Assuring data quality and validity in clinical trials for regulatory decision making (Text) |1 https://id.oclc.org/worldcat/entity/E39PCFVXv6K7vJQCgqXYMvMy7d |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |t Assuring data quality and validity in clinical trials for regulatory decision making. |d Washington, DC : National Academy Press, ©1999 |z 0309065941 |w (DLC) 00500867 |w (OCoLC)48761213 |
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Datensatz im Suchindex
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| _version_ | 1816881589778382848 |
| adam_text | |
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| author2 | Davis, Jonathan R. |
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| author_GND | http://id.loc.gov/authorities/names/n00010006 |
| author_corporate | Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices |
| author_corporate_role | |
| author_facet | Davis, Jonathan R. Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices |
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| contents | Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices. |
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| genre_facet | Electronic books. Congress proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. |
| id | ZDB-4-EBA-ocm44964812 |
| illustrated | Illustrated |
| indexdate | 2024-11-27T13:15:07Z |
| institution | BVB |
| institution_GND | http://id.loc.gov/authorities/names/no99081645 |
| isbn | 0585142610 9780585142616 030952024X 9780309520249 |
| language | English |
| oclc_num | 44964812 |
| open_access_boolean | |
| owner | MAIN DE-863 DE-BY-FWS |
| owner_facet | MAIN DE-863 DE-BY-FWS |
| physical | 1 online resource (xii, 76 pages) : illustrations |
| psigel | ZDB-4-EBA |
| publishDate | 1999 |
| publishDateSearch | 1999 |
| publishDateSort | 1999 |
| publisher | National Academy Press, |
| record_format | marc |
| series | Compass series (Washington, D.C.) |
| series2 | The compass series |
| spelling | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors. Washington, DC : National Academy Press, ©1999. 1 online resource (xii, 76 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier data file The compass series Includes bibliographical references (pages 75-76). Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices. Print version record. English. United States. Food and Drug Administration. United States. Food and Drug Administration fast Clinical trials Quality control. Clinical trials Data processing Congresses. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 Quality control. http://id.loc.gov/authorities/subjects/sh85109440 United States Food and Drug Administration Clinical Trials standards Decision Making https://id.nlm.nih.gov/mesh/D003657 Quality Control https://id.nlm.nih.gov/mesh/D011786 Research Design https://id.nlm.nih.gov/mesh/D012107 Études cliniques Qualité Contrôle. Études cliniques Informatique Congrès. Prise de décision. Qualité Contrôle. decision making. aat quality control. aat MEDICAL Drug Guides. bisacsh MEDICAL Nursing Pharmacology. bisacsh MEDICAL Pharmacology. bisacsh MEDICAL Pharmacy. bisacsh Quality control fast Decision making fast Clinical trials Data processing fast Andre fag (naturvidenskab og teknik) Andre fag. Electronic books. Congress https://id.nlm.nih.gov/mesh/D016423 proceedings (reports) aat Conference papers and proceedings fast Conference papers and proceedings. lcgft http://id.loc.gov/authorities/genreForms/gf2014026068 Actes de congrès. rvmgf Davis, Jonathan R. http://id.loc.gov/authorities/names/n00010006 Institute of Medicine (U.S.). Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. http://id.loc.gov/authorities/names/no99081645 has work: Assuring data quality and validity in clinical trials for regulatory decision making (Text) https://id.oclc.org/worldcat/entity/E39PCFVXv6K7vJQCgqXYMvMy7d https://id.oclc.org/worldcat/ontology/hasWork Print version: Assuring data quality and validity in clinical trials for regulatory decision making. Washington, DC : National Academy Press, ©1999 0309065941 (DLC) 00500867 (OCoLC)48761213 Compass series (Washington, D.C.) http://id.loc.gov/authorities/names/n97013362 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=14144 Volltext |
| spellingShingle | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Compass series (Washington, D.C.) Executive summary -- Introduction -- Presubmission and submission -- FDA regulatory review -- Summary of issues -- Directions for the future -- Final comments -- Appendices. United States. Food and Drug Administration. United States. Food and Drug Administration fast Clinical trials Quality control. Clinical trials Data processing Congresses. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 Quality control. http://id.loc.gov/authorities/subjects/sh85109440 United States Food and Drug Administration Clinical Trials standards Decision Making https://id.nlm.nih.gov/mesh/D003657 Quality Control https://id.nlm.nih.gov/mesh/D011786 Research Design https://id.nlm.nih.gov/mesh/D012107 Études cliniques Qualité Contrôle. Études cliniques Informatique Congrès. Prise de décision. Qualité Contrôle. decision making. aat quality control. aat MEDICAL Drug Guides. bisacsh MEDICAL Nursing Pharmacology. bisacsh MEDICAL Pharmacology. bisacsh MEDICAL Pharmacy. bisacsh Quality control fast Decision making fast Clinical trials Data processing fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh85036199 http://id.loc.gov/authorities/subjects/sh85109440 https://id.nlm.nih.gov/mesh/D003657 https://id.nlm.nih.gov/mesh/D011786 https://id.nlm.nih.gov/mesh/D012107 https://id.nlm.nih.gov/mesh/D016423 http://id.loc.gov/authorities/genreForms/gf2014026068 |
| title | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / |
| title_auth | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / |
| title_exact_search | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / |
| title_full | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors. |
| title_fullStr | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors. |
| title_full_unstemmed | Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors. |
| title_short | Assuring data quality and validity in clinical trials for regulatory decision making : |
| title_sort | assuring data quality and validity in clinical trials for regulatory decision making workshop report roundtable on research and development of drugs biologics and medical devices |
| title_sub | workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / |
| topic | United States. Food and Drug Administration. United States. Food and Drug Administration fast Clinical trials Quality control. Clinical trials Data processing Congresses. Decision making. http://id.loc.gov/authorities/subjects/sh85036199 Quality control. http://id.loc.gov/authorities/subjects/sh85109440 United States Food and Drug Administration Clinical Trials standards Decision Making https://id.nlm.nih.gov/mesh/D003657 Quality Control https://id.nlm.nih.gov/mesh/D011786 Research Design https://id.nlm.nih.gov/mesh/D012107 Études cliniques Qualité Contrôle. Études cliniques Informatique Congrès. Prise de décision. Qualité Contrôle. decision making. aat quality control. aat MEDICAL Drug Guides. bisacsh MEDICAL Nursing Pharmacology. bisacsh MEDICAL Pharmacology. bisacsh MEDICAL Pharmacy. bisacsh Quality control fast Decision making fast Clinical trials Data processing fast |
| topic_facet | United States. Food and Drug Administration. United States. Food and Drug Administration Clinical trials Quality control. Clinical trials Data processing Congresses. Decision making. Quality control. United States Food and Drug Administration Clinical Trials standards Decision Making Quality Control Research Design Études cliniques Qualité Contrôle. Études cliniques Informatique Congrès. Prise de décision. Qualité Contrôle. decision making. quality control. MEDICAL Drug Guides. MEDICAL Nursing Pharmacology. MEDICAL Pharmacology. MEDICAL Pharmacy. Quality control Decision making Clinical trials Data processing Electronic books. Congress proceedings (reports) Conference papers and proceedings Conference papers and proceedings. Actes de congrès. |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=14144 |
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