SoCRANewYorkStateChapterSummerEducationProgram
WelchAllynLodge,4355StateStreetRd.,SkaneatelesFalls,NY
Friday,July15,2016
8:00a.m.
8:30–8:40a.m.
8:40–9:40a.m.
ContinentalBreakfastandSign-In
WelcomeandIntroduction:KathiDurdon,MA,CCRP,SoCRANYSChapter
EthicalIssuesinEarly-PhaseClinicalTrialsandAccesstoExperimentalTherapies
AmyCarusoBrown,Professor,DepartmentofBioethicsandHumanities,SUNY
UpstateMedicalUniversity,Syracuse,NY
Abstract:Early-phaseclinicaltrialspresentuniqueethicalchallengesforpotentialparticipantsandtheir
families;informedconsentisneithernecessarynorsufficienttoassurethatastudyisethical.Further
challengesareposedwhenfamiliesdemandaccesstoexperimentaltherapiesoutsidethecontextofclinical
trial.Wewilldiscussapproachestoresolvingtheseissues.
9:40–10:40a.m.
ClinicalTrialManagementSystemSiteIntegrations–ToIntegrateorNot,Thatis
thequestion?’
LisaMartone,SalesExecutive,Bio-Optronics,Inc.
Abstract:Thispresentationwillencompassthevarietyofsystemsutilizedbythesitesandhowtobest
accomplishcompliance,patientsafetyandresearchthemostefficientwaypossible.Sometimesthisdoesnot
includeintegratingeverythingandthiswillbeuniquedependingontheindividualsitesandtheir
correspondingworkflow.
10:40–11:40p.m.
You’veReceivedanFDAForm483.Nowwhatdoyoudo?
AthenaThomas-Visel,MA,MEngrRD,CCRP,RQAP-GCP,PMP,CliqSolutions
Abstract:Howtodevelopandimplementacorrectiveandpreventativeactionplan.Thistalkwilloutline
howtoconductarootcauseanalysis,determinethenecessarycorrectiveandpreventativeactionneededto
betaken,andefficientlycommunicatetheplaninyourresponse.
11:45–12:45p.m.
Lunch
12:45–1:45p.m.
12SiteTips,Tools&TechniquestoMakeLifeEasier
LinFeng,Sr.ClinicalResearchCoordinator,Dept.ofSurgery,UniversityatBuffalo
Abstract:Resources,expertiseandbestpracticeswillbeprovidedforallresearchstaff
includingcoordinators,investigatorsandpartners/affiliates.Thesepracticaltools,tipsandtechniqueswill
beadaptabletoyourpractice,applicabletoyourdaytodaydutiesandwillmakeyourlifealittleeasier.
1:45–2:45p.m.
MonitorPanel
Abstract:Thispanelofexperiencedsiteandindustryclinicalresearchmonitorswillanswerattendee
questionsregardingsiteissues,monitoringissues,bestMonitoringpractice,changesintheindustryandhow
tomovefromsitecoordinatortomonitor.
2:45–3:15p.m.
ProgramQ&A
Programattendeesmaybecreditedfor(upto)5.5hoursContinuingEducationCreditHours(CEUsarein
Process).Eachparticipantshouldclaimonlythosehoursofcreditthathe/sheactuallyspentinthe
educationalactivity
TheSocietyofClinicalResearchAssociates(SoCRA-www.SoCRA.org)acceptsdocumentationofcandidateparticipationincontinuing
educationprogramsforre-certificationiftheprogramisapplicabletoclinicalresearchregulations,operationsormanagement,ortothe
candidate’sclinicalresearchtherapeuticarea."