LEADER 02167nam 2200397 450 001 9910583073803321 005 20230120002518.0 010 $a0-12-804730-5 035 $a(CKB)3710000001400292 035 $a(MiAaPQ)EBC4873523 035 $a(EXLCZ)993710000001400292 100 $a20170706h20172017 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 02$aA comprehensive and practical guide to clinical trials /$fedited by Delva Shamley, Brenda Wright, the Clinical Research Centre at the University of Cape Town, Cape Town, Western Cape Province, South Africa 210 1$aLondon, [England] :$cAcademic Press,$d2017. 210 4$dİ2017 215 $a1 online resource (212 pages) 311 $a0-12-804729-1 320 $aIncludes bibliographical references and index. 327 $aIntroduction to clinical trials / Brenda Wright -- Clinical trial phases / Brenda Wright -- Setting up of site, site assessment visits, and selection / Brenda Wright -- Regulatory requirements / Inge Vermeulen -- Contracts and agreements / Brenda Wright -- Protocol, informed consent documents, and investigator brochure / Brenda Wright -- Planning / Brenda Wright -- Recruitment and retention / Brenda Wright -- Training / Brenda Wright -- Data management / Annemie Stewart -- Investigational medicinal product (IMP) management / Wynand Smythe and Nicky Kramer -- Collecting, processing, and shipment of blood and urine samples / Brenda Wright -- Source document / Brenda Wright -- Screening, treatment, and safety follow-up visit / Brenda Wright -- Quality management / Brenda Wright -- Monitoring, close-out visits, and archiving / Brenda Wright -- Audits and inspections / Brenda Wright. 606 $aClinical trials$vHandbooks, manuals, etc 615 0$aClinical trials 676 $a615.50724 702 $aShamley$b Delva 702 $aWright$b Brenda 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910583073803321 996 $aA comprehensive and practical guide to clinical trials$92265569 997 $aUNINA