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1 c rkley xt st w rkly c rkley xt st with rkly c rkley xtn Crtificat Program st in with rkly c rk xt st with rkl c rkley xt st w rkly Clinical c Rsarch rkley xt st with rkly c rkley xtn Condct st and with Managmnt rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt B Yor Bst With Brkly st with rkly c rkley xtn Advanc Yor Carr st with rkly in Class or c Onlin rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xtn st with rkly c rk

2 Larn vrything yo nd to know to gin an xciting carr in th growing fild of clinical rsarch. Offrd onlin or in a hyrid onlin-classroom format, this profssional crtificat provids a thorogh ovrviw of th rglations and gidlins that govrn clinical trials, a hman tsting procdr that is an ssntial part of th drg dvlopmnt procss for iopharmactical companis. At UC Brkly Ext, gt th training yo nd to assm th rols and rsponsiilitis ncssary to rn clinical trials. In addition, yo can prpar to ntr or advanc in a carr as a monitor, clinical rsarch associat (CRA), projct managr, or stdy coordinator at iotchnology and pharmactical companis, contract rsarch organizations, and invstigational sits. Yo can complt this stramlind st of accrditd corss within on yar. For convninc, yo can nroll in th onlin format or hyrid format (50 prcnt classroom and 50 prcnt onlin instrction). With hyrid corss, yo ngag dirctly with th instrctors, many of whom ar indstry profssionals from lading Bay Ara iotchnology companis. For additional flxiility, yo can mov frly twn th hyrid and onlin formats, as long as yo complt all corss in sqntial ordr. Whthr yo r nw to clinical rsarch or alrady working in th fild, UC Brkly Ext offrs yo th skills to sccd.

3 c rkley xt st w rkly c rkley xt st with rkly c rkley xt st with rkly c rk xt st with rkl c rkley xt st w rkly Clinical c Rsarch rkley xt st with rkly c rkley xt Condct st and with Managmnt rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st Rqird with Corss rkly c rkley xt 4 Corss, 12 st Smstr with Units, 180 rkly Hors of Instrction c rk xt st with rkl c rkley Introdction to Clinical xt Rsarch: Clinical Trial Phass and Dsign PB HLTH st X400.2 w rkly Rviw th drg c dvlopmnt rkley procss, th principls xt of good clinical practic, th clinical trial phass and dsign, th principal playrs in clinical st with rkly c rkley xt rsarch, and rglatory stratgis for dvloping mdical dvics and mdical trminology. st Bcom with an xprt rkly in Food and Drg Administration c rk xt st with rkl c rkley (FDA) rglations, th xt Intrnational Confrnc on Harmonisation (ICH), Good Clinical Practics (GCP), and procdral gidlins. st w rkly Clinical Trial Planning: c Protocol rkley Dvlopmnt, Data xt Managmnt st with and Clinical Sit rkly Activitis PB HLTH X400.3 c rkley xt Larn th procsss st and with procdrs inhrnt rkly to planning clinical trials c rk xt inclding protocol dvlopmnt, cas rport st form dsign, with IRB smission, rkl sit slction, dvlopmnt and ngotiating sit contracts and dgts, c rkley xt st w and pr-stdy visits. rkly c rkley xt st with Clinical Trial rkly Implmntation: Sit Initiation, c Sjct rkley Rcritmnt, xt Monitoring st and Safty PB with HLTH X400.4 rkly c rk xt Gt a thorogh look at th rol of clinical st trial monitors. with Rviw in rkl dtail th varios aspcts of stdy monitoring, sch as data rviw, safty c rkley rporting, and drg xt accontaility. Stdy gloal drg dvlopmnt and st w rkly sjct rcritmnt c and rkley rtntion, topics that ar xt crcial to mting stdy st with timlins. rkly c rkley xt st with rkly c rk Clinical Trial: Data Analysis, Rglatory Adits, Vndor Slction xt and Projct Managmnt PB HLTH X400.5 st with rkl c rkley Larn th clinical stdy xt rport and othr procdrs at stdy clos-ot to st w rkly prpar slf c for rglatory rkley adits and inspctions. xt Gt an ovrviw of st with projct managmnt rkly and vndor slction c in clinical rkley rsarch. xt st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt st with rkly c rkley xt st with rkly c rk xt st with rkl c rkley xt st w rkly c rkley xt Larn Mor st with rkly c rkley xt st with rkly c rk

4 ith ley y ith ley y ith ley y ith ley y ith ley y ith ley y ith ley y ith ley y ith ley y ith ley Crriclm Rqirmnts Th crriclm consists of 4 rqird corss for a total of 12 smstr nits (180 hors of instrction). This profssional crtificat is taght in oth a hyrid format that consists of 50 prcnt classroom instrction and 50 prcnt onlin instrction and an onlin format. Th hyrid format nals stdnts to participat in th classroom in addition to taking onlin corss. Stdnts can pick and choos which corss thy want to tak in th classroom and which thy prfr to tak onlin. In th onlin format, stdnts tak all for rqird corss onlin. In oth th hyrid and onlin programs, all corss mst takn sqntially. Yo can nroll in corss via th wsit, as wll as rgistr for th crtificat at xt.rkly.dcrtrgistr. All corswork mst compltd within fiv yars of rgistring for th crtificat. Howvr, rqirmnts may pdatd asd on nw dvlopmnts in th fild of stdy; w rcommnd complting th crriclm in a timly fashion. Compltion Rqirmnts Yo mst tak all corss for a lttr grad. To rciv th crtificat, yo mst maintain an ovrall minimm 2.5 grad point avrag, with a grad of C or ttr in ach cors. Th crtificat can compltd in two smstrs (on yar). How to Rgistr for Yor Crtificat To rgistr for th Crtificat Program in Clinical Rsarch Condct and Managmnt, complt th form at xt.rkly.dcrtrgistr. Mail it as it indicats, and incld th nonrfndal crtificat rgistration f. W rcommnd that yo rgistr for th crtificat for yo gin scond cors in th crriclm. Yo may nroll in th crtificat corss withot rgistring for th Crtificat Program in Clinical Rsarch Condct and Managmnt. Visit xt.rkly.dcrtclinical.html

5

6 Advisory Board Jan M. Alxandr, B.S.N., M.P.H. Associat Dirctor, Clinical Oprations Ilypsa, Inc. Lincoln Bynm, M.D. Vic Prsidnt for Mdical Conslting and Prodct Dvlopmnt Srvics ICON Clinical Rsarch Szann Handl, J.D., CLP Dirctor, Tchnology Transfr Offic Childrn s Hospital & Rsarch Cntr Oakland Karn A. Hnry, BBA, M.P.H. Clinical Oprations Consltant Advancd Clinical Srvics Mng C. Lin, O.D., Ph.D., FAAO Assistant Clinical Profssor School of Optomtry, UC Brkly Dirctor UC Brkly Clinical Rsarch Cntr (CRC) Madlin Millr, D.V.M., M.S. Exctiv Vic Prsidnt and COO BioSotria, Inc. Barara A. Ptrson, Ph.D. Program Dirctor, Scincs and Mathmatics UC Brkly Ext Knnth A. Pols, O.D., M.S. Profssor of th Gradat School Brkly Clinical Scintist Dvlopmnt Program Dirctor School of Optomtry, UC Brkly Arthr Ringold, M.D. Profssor and Had of Epidmiology Associat Dan for Rsarch School of Plic Halth, UC Brkly Charls Schwamlin, M.D., M.P.H. Drg Safty Consltant Bvrly D. Smolich, Ph.D. Biotchnology R&D Consltant Hln Strt, M.S., RN CEO, Clinical Rsarch H Strt Conslting Mariana Tran, M.B.A., Ph.D. Vic Prsidnt, Bsinss Dvlopmnt and Oprations Cardinal Clinical Rsarch, Inc. Liz Wool, BSN, CCRA, CMT Prsidnt and CEO QD-Qality and Training Soltions, Inc. Board of Trsts, Association of Clinical Rsarch Profssionals (ACRP) Editorial Advisory Board, ACRP s Th Monitor Prsidnt, Northrn California Chaptr ACRP Profssional Organizations UC Brkly Ext is an approvd providr of contining dcation nits (CEUs) y th California Board of Rgistrd Nrsing (BRN). Providr All corss in this crtificat ar also accptd y th Association of Clinical Rsarch Profssionals (ACRP) as flfilling th dcational rqirmnt for crtification. Val of a UC Brkly Profssional Crtificat As th contining dcation arm of UC Brkly, UC Brkly Ext is a rspctd providr of adlt and profssional dcation. A UC Brkly Ext profssional crtificat is approvd y a UC Brkly acadmic advisory oard and widly rcognizd as proof of th sccssfl compltion of a high-calir, in-dpth cors of stdy. UC Brkly Ext is accrditd y th Wstrn Association of Schools and Collgs. Additional Information To larn mor aot th Crtificat Program in Clinical Rsarch Condct and Managmnt, contact call (510) , or visit xt.rkly.dcrtclinical.html. For mor information aot th onlin larning xprinc, visit xt.rkly.donlin. Enroll Now Visit xt.rkly.dcrtclinical.html 2010 y th Rgnts of th Univrsity of California BBSM 110BR M

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