OPDR Definition - Law Insider

Define OPDR. means Offset Project Data Report. ... training from an approved source listed on the Oklahoma Professional Development Registry (OPDR) website. OPDRdefinitionRelatedDefinitionsTreatabilitystudyTargetPopulationPhaseIIIClinicalTrialsPhaseIIClinicalTrialsPhaseIIIClinicalTrialPhaseIIIClinicalStudyPivotalClinicalTrialPhaseIIClinicalTrialPhase4ClinicalTrialPhaseIIClinicalStudyPhase2ClinicalTrialPhaseIClinicalTrialPhase3ClinicalTrialCardiopulmonaryresuscitationPhaseIVClinicalTrialSystemImpactStudyPhaseIClinicalStudyGenetictestingPhase1ClinicalTrialCOVID-19testPhaseIIbClinicalTrialStudyClinicalevaluationPhaseIIIStudymultiplesclerosisHEPAfilterRemoveAdvertisingOpenSplitViewShareCiteOPDR meansOffsetProjectDataReport.Sample1Sample2Sample3Basedon13documents13SaveCopyRemoveAdvertisingOPDR meansOffsetProjectDevelopmentReport.Sample1Sample2Sample3Basedon7documents7SaveCopyOPDR meansOffsetProjectDevelopmentReport.(30)“OPO”meansOffsetProjectOperator.Sample1Sample2Basedon2documents2SaveCopyExamplesofOPDRinasentencePriorto,orwithin90calendardaysofemployment,teachingpersonnelhiredafterAugust1,2003,completeanapprovedentry-leveltraininglistedontheOklahomaProfessionalDevelopmentRegistry(OPDR)website,suchasELCCT.Priortoorwithinthreemonthsofassumingprimaryresponsibilitiesforfoodpreparation,foodservicepersonnelobtainfoodservicetrainingfromanapprovedsourcelistedontheOklahomaProfessionalDevelopmentRegistry(OPDR)website.THEREVISEDDEFINITIONSFOR"COMMERCIAL"AND"RESEARCHANDDEVELOPMENT"INRULES1.2AND1.11AREINTENDEDTOESTABLISHACLEARSEPARATIONBETWEENTHEACTIVITIESALLOWEDUNDERACOMMERCIALREGISTRATIONANDARESEARCHANDDEVELOPMENTREGISTRATION.TheOffsetProjectOperatorand/orAuthorizedProjectDesigneemustindicatethissituationintheOPDRforthatreportingperiodandshouldreportzeroGHGemissionreductions.Cardio-pulmonaryresuscitation(CPR)andfirstaidcertificationsareage-appropriatefortheagesofchildrenacceptedintocareandarefromapprovedsourceslistedontheOPDRwebsite.AllverificationissubmittedtotheOklahomaProfessionalDevelopmentRegistry(OPDR),unlessenteredbyanOPDRapprovedtrainer.ThisfilehasbeenapprovedforreleasebytheOPDRDisclosureReviewBoard.GeographicInformationSysteminEgypt,Adevelopingconnection:Bridgingthepolicygapbetweentheinformationsocietyandsustainabledevelopment.Evenwiththevariablesmasked,however,theNBSpublicusefileoffersawidevarietyofpertinentvariablesandtopicsforthegeneralpublictouse.UsingSSA’sOfficeofProgramDevelopmentandResearch’s(OPDR)DisclosureChecklistforthePublicReleaseofData,wedevelopedencryption/maskingalgorithmsthatwouldmaximizetheanalyticvalueofthedatawhilemaintainingacceptableconfidentialityfortheprogramparticipants.Whentheprogramprovidestransportationfor5-year-oldsoryounger,theprogramhasatleastonepersonnelwhoobtainedchildpassengersafetytrainingfromanapprovedsourcelistedontheOPDRwebsite,unlessthevehiclesusedareexemptperOAC340:110-3-305(g).MoreDefinitionsofOPDROPDR meanstheOdishaPublicDemandRecoveryAct,1962;Sample1Basedon1documents1SaveCopyRelatedtoOPDRTreatabilitystudymeansastudyinwhichahazardouswasteissubjectedtoatreatmentprocesstodetermine:(1)Whetherthewasteisamenabletothetreatmentprocess,(2)whatpretreatment(ifany)isrequired,(3)theoptimalprocessconditionsneededtoachievethedesiredtreatment,(4)theefficiencyofatreatmentprocessforaspecificwasteorwastes,or(5)thecharacteristicsandvolumesofresidualsfromaparticulartreatmentprocess.Alsoincludedinthisdefinitionforthepurposeofthe§261.4(e)and(f)exemptionsarelinercompatibility,corrosion,andothermaterialcompatibilitystudiesandtoxicologicalandhealtheffectsstudies.A“treatabilitystudy”isnotameanstocommerciallytreatordisposeofhazardouswaste.TargetPopulationmeanspersonswithlowincomeswhohaveoneormoredisabilities,includingmentalillness,HIVorAIDS,substanceabuse,orotherchronichealthcondition,orindividualseligibleforservicesprovidedpursuanttotheLantermanDevelopmentalDisabilitiesServicesAct(Division4.5(commencingwithSection4500)oftheWelfareandInstitutionsCode)andmayinclude,amongotherpopulations,adults,emancipatedminors,familieswithchildren,elderlypersons,youngadultsagingoutofthefostercaresystem,individualsexitingfrominstitutionalsettings,veterans,andhomelesspeople.PhaseIIIClinicalTrialsmeansthosetrialsonsufficientnumbersofpatientsthataredesignedtoestablishthatadrugissafeandefficaciousforitsintendeduse,andtodefinewarnings,precautionsandadversereactionsthatareassociatedwiththedruginthetobeprescribeddosagerange,andsupportingRegulatoryApprovalofsuchdrug.PhaseIIClinicalTrialsmeansthosetrialsintheTerritoryonalimitednumberofpatientsthataredesignedtoestablishthesafetyandbiologicalactivityofadrugforitsintendeduseandtodefinewarnings,precautionsandadversereactionsthatareassociatedwiththedruginthedosagerangetobeprescribed.PhaseIIIClinicalTrialmeansahumanclinicaltrialinanycountry,theresultsofwhichcouldbeusedtoestablishsafetyandefficacyofaProductasabasisforanNDAorwouldotherwisesatisfyrequirementsof21CFR312.21(c),oritsforeignequivalent.PhaseIIIClinicalStudymeans,astoaparticularLicensedProduct,aclinicalstudyinhumansthatisprospectivelydesignedtoassessthesafetyandeffectivenessofsuchLicensedProductinamannersufficienttofileaDrugApprovalApplicationfortheIndicationunderinvestigationinthestudy.Withoutlimitingthegeneralityoftheforegoing,aclinicalstudyshallbedeemedtobea“PhaseIIIClinicalStudy”hereunderifsuchstudyhasbeendesignatedbythesponsorasaPhaseIIIclinicaltrialonwww.clinicaltrials.gov(oranysuccessorwebsitemaintainedbytheU.S.NationalInstitutesofHealth(oranysuccessoragencyoftheU.S.Government)).PivotalClinicalTrialmeans(i)ahumanclinicaltrialofaProductthatisintendedtobeapivotaltrialforobtainingRegulatoryApproval(e.g.,intheUnitedStatessuchclinicaltrialisconductedaftertheendofphase2meetingwiththeFDA)andtootherwiseestablishsafetyandefficacyinpatientswiththediseaseorconditionbeingstudiedandtoprovideanadequatebasisforphysicianlabeling,forpurposesoffilingaMAAforProduct,andthatwouldsatisfytherequirementsunder21C.F.R.312.21(c)orforeignequivalentsthereof,or(ii)anyotherclinicaltrialthatisintendedtoestablishthatapharmaceuticalproductissafeandefficaciousforitsintendeduse,andtodeterminewarnings,precautions,andadversereactionsthatareassociatedwithsuchpharmaceuticalproductinthedosagerangetobeprescribed,whichclinicaltrialisaregistrationtrialintendedtobesufficientforfilinganapplicationforaRegulatoryApprovalforsuchproductintheUnitedStatesoranothercountryorsomeorallofanextra-nationalterritory,solelyasevidencedbytheacceptanceforfilingforaRegulatoryApprovalforsuchproductaftercompletionofsuchclinicaltrial.PhaseIIClinicalTrialmeansahumanclinicaltrialinanycountrythatisintendedtoinitiallyevaluatetheeffectivenessofaProductforaparticularindicationorindicationsinpatientswiththediseaseorindicationunderstudyorwouldotherwisesatisfyrequirementsof21CFR312.21(b),oritsforeignequivalent.Phase4ClinicalTrialmeansaproductsupportclinicaltrialofaProductthatiscommencedafterreceiptofMAAApprovalinthecountrywheresuchtrialisconducted.Phase4ClinicalTrialmayincludeepidemiologicalstudies,modelingandpharmacoeconomicstudiesandpost-marketingsurveillancetrials.PhaseIIClinicalStudymeans,astoaparticularLicensedProductforaparticularindication,acontrolledandlawfulstudyinhumansofthesafety,doserangingandefficacyofsuchLicensedProductforsuchindication,whichisprospectivelydesignedtogeneratesufficientdata(ifsuccessful)tocommenceaPhaseIIIClinicalTrialofsuchLicensedProductforsuchindication.Phase2ClinicalTrialmeansahumanclinicaltrialofaproductinanycountrythatwouldsatisfytherequirementsof21C.F.R.312.21(b)andisintendedtoexploreavarietyofdoses,doseresponse,anddurationofeffect,andtogenerateinitialevidenceofclinicalsafetyandactivityinatargetpatientpopulation,orasimilarclinicalstudyprescribedbytherelevantRegulatoryAuthoritiesinacountryotherthantheUnitedStates.PhaseIClinicalTrialmeansahumanclinicaltrialthatisintendedtoinitiallyevaluatethesafetyand/orpharmacologicaleffectofaProductinsubjectsorthatwouldotherwisesatisfyrequirementsof21C.F.R.312.21(a),oritsforeignequivalent.Phase3ClinicalTrialmeansahumanclinicaltrialofaproductinanycountrythatwouldsatisfytherequirementsof21C.F.R.312.21(c)andisintendedto(a)establishthattheproductissafeandefficaciousforitsintendeduse,(b)definewarnings,precautionsandadversereactionsthatareassociatedwiththeproductinthedosagerangetobeprescribed,and(c)supportRegulatoryApprovalforsuchproduct.Cardiopulmonaryresuscitation(CPR)meansmeasurestorestorecardiacfunctionortosupportbreathingintheeventofcardiacorrespiratoryarrestormalfunction.“CPR”includes,butisnotlimitedto,artificialventilation,chestcompression,deliveringelectricshock,placingtubesintheairwaytoassistbreathingorotherbasicandadvancedresuscitativetherapies.PhaseIVClinicalTrialmeansaproductsupportclinicaltrialofaProductcommencedafterreceiptofRegulatoryApprovalinthecountrywheresuchtrialisconducted.APhaseIVClinicalTrialmayincludeepidemiologicalstudies,modelingandpharmacoeconomicstudies,andinvestigator-sponsoredclinicaltrialsstudyingProductthatareapprovedbytheJDCandthatotherwisefittheforegoingdefinition.SystemImpactStudymeansanassessmentbytheTransmissionProviderof(i)theadequacyoftheTransmissionSystemtoaccommodateaCompletedApplication,anInterconnectionRequestoranUpgradeRequest,(ii)whetheranyadditionalcostsmaybeincurredinordertoprovidesuchtransmissionserviceortoaccommodateanInterconnectionRequest,and(iii)withrespecttoanInterconnectionRequest,anestimateddatethatanInterconnectionCustomer’sCustomerFacilitycanbeinterconnectedwiththeTransmissionSystemandanestimateoftheInterconnectionCustomer’scostresponsibilityfortheinterconnection;and(iv)withrespecttoanUpgradeRequest,theestimatedcostoftherequestedsystemupgradesorexpansion,orofthecostofthesystemupgradesorexpansion,necessarytoprovidetherequestedincrementalrights.SystemProtectionFacilities:“SystemProtectionFacilities”shallrefertotheequipmentrequiredtoprotect(i)theTransmissionSystem,otherdeliverysystemsand/orothergeneratingsystemsconnectedtotheTransmissionSystemfromfaultsorotherelectricaldisturbanceoccurringatorontheCustomerFacility,and(ii)theCustomerFacilityfromfaultsorotherelectricalsystemdisturbanceoccurringontheTransmissionSystemoronotherdeliverysystemsand/orothergeneratingsystemstowhichtheTransmissionSystemisdirectlyorindirectlyconnected.SystemProtectionFacilitiesshallincludesuchprotectiveandregulatingdevicesasareidentifiedintheApplicableTechnicalRequirementsandStandardsorthatarerequiredbyApplicableLawsandRegulationsorotherApplicableStandards,orasareotherwisenecessarytoprotectpersonnelandequipmentandtominimizedeleteriouseffectstotheTransmissionSystemarisingfromtheCustomerFacility.TransmissionFacilities:PhaseIClinicalStudymeans,astoaparticularLicensedProduct,aninitialclinicalstudyinhumanswiththepurposeofassessingtheLicensedProduct’ssafety,tolerability,toxicity,pharmacokineticsorotherpharmacologicalproperties.Genetictestingmeansananalysisofgeneticmarkerstoexcludeoridentifyamanasthefatherorawomanasthemotherofachild.Thetermincludesananalysisofoneoracombinationofthefollowing:Phase1ClinicalTrialmeansahumanclinicaltrialofaproductinanycountry,theprincipalpurposeofwhichisapreliminarydeterminationofsafetyinhealthyindividualsorpatients,thatwouldsatisfytherequirementsof21C.F.R.312.21(a),orasimilarclinicalstudyprescribedbytherelevantRegulatoryAuthoritiesinacountryotherthantheUnitedStates.COVID-19testmeansaviraltestforSARS-CoV-2thatis:PhaseIIbClinicalTrialmeansarelativelylongerandlargerPhaseIIClinicalStudydesignedtostudytheeffectivenessofdifferentdosesofaparticularProductagainstplaceboorotherpositivecontrolsforaparticularIndicationinpatientswiththediseaseorconditionunderstudy,whichisdeterminedbythePDCtobeaPhaseIIBClinicalStudy.StudymeanstheinvestigationtobeconductedinaccordancewiththeProtocol.Clinicalevaluationmeansasystematicandplannedprocesstocontinuouslygenerate,collect,analyseandassesstheclinicaldatapertainingtoadeviceinordertoverifythesafetyandperformance,includingclinicalbenefits,ofthedevicewhenusedasintendedbythemanufacturer;PhaseIIIStudymeansahumanclinicaltrialthatisprospectivelydesignedtodemonstratestatisticallywhetheraproductissafeandeffectiveforuseinhumansinamannersufficienttoobtainregulatoryapprovaltomarketsuchproductinpatientshavingthediseaseorconditionbeingstudiedasdescribedin21C.F.R.§312.21(c)(FDCA),asamendedfromtimetotime,andtheforeignequivalentthereof.multiplesclerosismeansaninflammatory,nervoussystemdiseaseinwhichthemyelinsheathsaroundtheaxonsofnervecellsofthebrainandspinalcordaredamaged,leadingtodemyelinationandaffectingtheabilityofnervecellsinthebrainandspinalcordtocommunicatewitheachother;HEPAfiltermeanshigh-efficiencyparticulateairfiltersthatareratedtoachieveaminimuminitialparticle-removalefficiencyof99.97percentusingASTMF1471–93orequivalentstandard;