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1、PREFACEThisdocumentistheDMIDprotocoltemplate,whichisrequiredfordevelopingDMID-sponsoredclinicalresearchprotocols.Notethatinstructionsandexplanatorytextareindicatedbyitalicsandshouldbereplacedinyourprotocoldocumentwithappropriateprotocol-specifictext.Sectionheadingsandtemplatetextformattedinregularty
2、peshouldbeincludedinyourprotocoldocumentasprovidedinthetemplate.Thistemplateattemptstoprovideageneralformatapplicabletoallclinicaltrialsevaluatinganinvestigationalproduct.Wherespecificexamplesareprovided,theyareoftenfromthevaccinearea.ReferquestionsregardinguseofthisprotocoltemplatetotheappropriateD
3、MIDProtocolChampionorClinicalAffairsSpecialist.TITLEDMIDProtocolNumber:DMIDFundingMechanism:(e.g.,grant#,contract#)PharmaceuticalSupportProvidedby:(ifapplicable)OtherIdentifyingNumbers:INDSponsor:(if即plicable)PrincipalInvestigator:DMIDProtocolChampion:DMIDMedicalMonitor:DMIDClinicalAffairsSpecialist
4、:DMIDRegulatoryAffairsSpecialist:(if即plicable)DraftorVersionNumber:(seeDMIDSOPforassigningversionnumbers)DayMonthYear(Writeoutthemonthanduseinternationaldateformat,e.g.,23January2004)ThistemplateisadaptedfromtheICHguidancedocumentE6(GoodClinicalPractices),Section6.StatementofComplianeeProvideastatem
5、entthatthetrialwillbeconductedincomplianeewiththeprotocol,InternationalConferenceonHarmonisationGoodClinicalPracticeE6(ICH-GCP)andtheapplicableregulatoryrequirements.Usetheapplicableregulationsandrequirementsdependingonstudylocationandsponsorrequirements.Examplesofrequirementsthatarepotentiallyappli
6、cableinclude:?U.S.CodeofFederalRegulationsapplicabletoclinicalstudies(45CFR46and21CFRincludingparts50and56concerninginformedconsentandIRBregulations,ifunderIND,21CFR312).?Directive9115071EEC:TheRulesGoverningMedicinalProductsintheEuropeanCommunity.?CompletionofHumanSubjectsProtectionTrainingReferto:
7、http:/grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.htmlhttp:/69.5433/cO1/*NIHClinicalTermsofAwardSIGNATUREPAGEThesignaturebelowconstitutestheapprovalofthisprotocolandtheattachments,andprovidesthenecessaryassurancesthatthistrialwillbeconductedaccordingtoallstipulationsoftheprotocol,includin
8、gallstatementsregardingconfidentiality,andaccordingtolocallegalandregulatoryrequirementsandapplicableU.S.federalregulationsandICHguidelines.TheLeadPI,thePIsfromallparticipatingclinicalsitesandotherkeypartiesshouldsignthesignaturepageasappropriate.PrincipalInvestigator:Signed:Date:NameTitle1.1.1 Stat
9、ementofComplianceiSignaturePageiiListofAbbreviationsviProtocolSummaryviiiKeyRoles1BackgroundInformationandScientificRationale3BackgroundInformation3Rationale3PotentialRisksandBenefits3PotentialRisks3KnownPotentialBenefits3Objectives4StudyDesign5StudyPopulation6SubjectInclusionCriteria7SubjectExclusi
10、onCriteria7Enrollment/Randomization/MaskingProcedures8StudyProcedures/Evaluations9ClinicalEvaluations9ConcomitantMedications/Treatments9LaboratoryEvaluations10ClinicalLaboratoryEvaluations10SpecialAssaysorProcedures10SpecimenPreparation,HandlingandShipping10Substudies11StudySchedule12Screening12Enro
11、llment/Baseline12Follow-up13FinalStudyVisit13EarlyTerminationVisit13StudyIntervention/InvestigationalProduct14StudyProductAcquisition14Formulation,PackagingandLabeling14ProductStorageandStability14Preparation,AdministrationandDosageofStudyIntervention/InvestigationalProduct14AccountabilityProcedures
12、fortheStudyIntervention/InvestigationalProduct(s).14AssessmentofSubjectCompliancewithStudyIntervention/InvestigationalProduct15AssessmentofScientificObjectives(e.g.,SafetyorImmunogenicityorEfficacy)16SpecificationoftheAppropriateOutcomeMeasures16PrimaryOutcomeMeasures16SecondaryOutcomeMeasures16Meth
13、odsandTimingforAssessing,Recording,andAnalyzingAppropriateOutcomeMeasures16ModificationandDiscontinuationofStudyIntervention/InvestigationalProductforaParticipant16Dose/ScheduleModificationsforaSubject16CriteriaforDiscontinuationofStudyIntervention/ProductforWithdrawalofaSubject(oraCohort)16Assessme
14、ntofSafety18SpecificationofSafetyParameters18MethodsandTimingforAssessing,Recording,andAnalyzingSafetyParameters18AdverseEvents,Reactogenicity(forVaccineStudies),SeriousAdverseEvents.18ReportingProcedures20SeriousAdverseEventDetectionandReporting20ReportingofPregnancy21ProcedurestobeFollowedintheEve
15、ntofAbnormalLaboratoryTestValuesorAbnormalClinicalFindings21TypeandDurationoftheFollow-upofSubjectsAfterAdverseEvents21HaltingRules21ClinicalMonitoringStructure23SiteMonitoringPlan23StatisticalConsiderations24Introduction24OverviewandStudyObjectives24StudyPopulation24StudyDesign24StudyOutcomeMeasure
16、s25StudyHypotheses25SampleSizeConsiderations25ParticipantEnrollmentandFollow-Up26PlannedInterimAnalyses(ifplanned)26SafetyReview26ImmunogenicityorEfficacyReview27FinalAnalysisPlan27SourceDocumentsandAccesstoSourceData/Documents28QualityControlandQualityAssurance29Ethics/ProtectionofHumanSubjects30DeclarationofHelsinki30InstitutionalReviewBoard30InformedConsentProcess30InformedConsent/AssentProcess(inCaseofaMinor)31ExclusionofWomen,Minoritie
