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008    000807s1999    dcua    ob    000 0 eng d 
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049    txum 
050  4 R853.C55|bA876 1999eb 
072  7 MED|x023000|2bisacsh 
072  7 MED|x058170|2bisacsh 
072  7 MED|x071000|2bisacsh 
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082 04 610.28|221eb 
245 00 Assuring data quality and validity in clinical trials for 
       regulatory decision making :|bworkshop report : Roundtable
       on Research and Development of Drugs, Biologics, and 
       Medical Devices /|cJonathan R. Davis [and others] editors.
260    Washington, DC :|bNational Academy Press,|c©1999. 
300    1 online resource (xii, 76 pages) :|billustrations. 
336    text|btxt|2rdacontent 
337    computer|bc|2rdamedia 
338    online resource|bcr|2rdacarrier 
347    data file|2rda 
490 1  The compass series 
504    Includes bibliographical references (pages 75-76). 
505 0  Executive summary -- Introduction -- Presubmission and 
       submission -- FDA regulatory review -- Summary of issues -
       - Directions for the future -- Final comments -- 
       Appendices. 
506    Available only to authorized UTEP users. 
546    English. 
588 0  Print version record. 
610 10 United States.|bFood and Drug Administration. 
610 17 United States.|bFood and Drug Administration.|2fast
       |0(OCoLC)fst00549734 
650  0 Clinical trials|xQuality control. 
650  0 Clinical trials|xData processing|vCongresses. 
650  2 United States Food and Drug Administration. 
650 12 Clinical Trials|xstandards|vCongresses. 
650 22 Decision Making|vCongresses. 
650 22 Quality Control|vCongresses. 
650 22 Research Design|vCongresses. 
655  0 Electronic books. 
655  2 Congress. 
655  7 Conference papers and proceedings.|2fast
       |0(OCoLC)fst01423772 
700 1  Davis, Jonathan R. 
710 2  Institute of Medicine (U.S.).|bRoundtable on Research and 
       Development of Drugs, Biologics, and Medical Devices. 
776 08 |iPrint version:|tAssuring data quality and validity in 
       clinical trials for regulatory decision making.
       |dWashington, DC : National Academy Press, ©1999
       |z0309065941|w(DLC)   00500867|w(OCoLC)48761213 
830  0 Compass series (Washington, D.C.) 
856 40 |uhttp://0-search.ebscohost.com.lib.utep.edu/
       login.aspx?direct=true&scope=site&db=nlebk&AN=14144|zTo 
       access this resource 
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