MARC Record from Library of Congress

LEADER: 01657cam a22003378a 4500
001 2009030187
003 DLC
005 20100219093959.0
008 090722s2009 nju bf 000 0 eng
010 $a 2009030187
020 $a9780937548707
035 $a(DNLM)101511306
040 $aDNLM/DLC$cDLC
042 $apcc
043 $an-us---
050 00 $aR853.C55$bN67 2009
060 10 $aQV 39$bN854c 2009
082 00 $a610.72$222
100 1 $aNorris, Deborrah.
245 10 $aClinical research coordinator handbook /$cDeborrah Norris.
250 $a4th ed.
260 $aMedford, NJ :$bPlexus Pub.,$cc2009.
263 $a0909
300 $ap. ;$ccm.
504 $aIncludes bibliographical references.
505 0 $aFederal regulations governing the obligations of clinical investigators of regulated articles -- The clinical research organization -- Investigator responsibilities -- Duties of the clinical research coordinator -- The creation of study source documents -- Obtaining informed consent and assent approval -- Pertinent forms and study records -- The prestudy site visit -- Recruiting and enrolling subjects -- Conducting the study and keeping records -- Preparing for an FDA audit -- Clinical research : potential liability -- Electronic data capture (EDC) and clinical trials.
650 0 $aClinical trials$zUnited States$vHandbooks, manuals, etc.
650 12 $aClinical Trials as Topic$xstandards$zUnited States$vHandbooks.
650 22 $aClinical Trials as Topic$xmethods$zUnited States$vHandbooks.
650 22 $aRecords as Topic$xstandards$zUnited States$vHandbooks.
650 22 $aResearch Design$xstandards$zUnited States$vHandbooks.