LEADER 03090nam 2200637Ia 450 001 9910784640803321 005 20230627201335.0 010 $a1-280-63341-7 010 $a9786610633418 010 $a0-08-045420-8 024 3 $z9780122107511 035 $a(CKB)1000000000364410 035 $a(EBL)269513 035 $a(OCoLC)85766756 035 $a(SSID)ssj0000275222 035 $a(PQKBManifestationID)11241104 035 $a(PQKBTitleCode)TC0000275222 035 $a(PQKBWorkID)10340656 035 $a(PQKB)10918136 035 $a(MiAaPQ)EBC269513 035 $a(Au-PeEL)EBL269513 035 $a(CaPaEBR)ebr10138125 035 $a(CaONFJC)MIL63341 035 $a(OCoLC)162571734 035 $a(PPN)132108178 035 $a(EXLCZ)991000000000364410 100 $a20040318d2006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aWriting clinical research protocols$b[electronic resource] $eethical considerations /$fEvan G. DeRenzo and Joel Moss 205 $aSecond edition. 210 $aBurlington, MA ;$aLondon $cElsevier Academic$dc2006 215 $a1 online resource (321 p.) 300 $aDescription based upon print version of record. 311 $a978-0-12-210751-1 311 $a0-12-210751-9 320 $aIncludes bibliographical references and index. 327 $aIntroduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience. 330 $aThis highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic 606 $aClinical trials 606 $aMedical protocols 615 0$aClinical trials. 615 0$aMedical protocols. 676 $a615.50724 700 $aDeRenzo$b Evan G$01570127 701 $aMoss$b Joel$01570128 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910784640803321 996 $aWriting clinical research protocols$93843574 997 $aUNINA