DMID Protocol Template文档格式.docx
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- 上传时间:2022-11-17
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DMID Protocol Template文档格式.docx
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(e.g.,grant#,contract#)
PharmaceuticalSupportProvidedby:
(ifapplicable)
OtherIdentifyingNumbers:
INDSponsor:
PrincipalInvestigator:
DMIDProtocolChampion:
DMIDMedicalMonitor:
DMIDClinicalAffairsSpecialist:
DMIDRegulatoryAffairsSpecialist:
DraftorVersionNumber:
(seeDMIDSOPforassigningversionnumbers)
DayMonthYear
(Writeoutthemonthanduseinternationaldateformat,e.g.,23January2004)
ThistemplateisadaptedfromtheICHguidancedocumentE6(GoodClinicalPractices),Section6.
StatementofCompliance
Provideastatementthatthetrialwillbeconductedincompliancewiththeprotocol,InternationalConferenceonHarmonisationGoodClinicalPracticeE6(ICH-GCP)andtheapplicableregulatoryrequirements.Usetheapplicableregulationsandrequirementsdependingonstudylocationandsponsorrequirements.Examplesofrequirementsthatarepotentiallyapplicableinclude:
∙U.S.CodeofFederalRegulationsapplicabletoclinicalstudies(45CFR46and21CFRincludingparts50and56concerninginformedconsentandIRBregulations,ifunderIND,21CFR312).
∙Directive9115071EEC:
TheRulesGoverningMedicinalProductsintheEuropeanCommunity.
∙CompletionofHumanSubjectsProtectionTraining
Referto:
http:
//grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html
//www.cancer.gov/clinicaltrials/learning/page3
∙NIHClinicalTermsofAward
SIGNATUREPAGE
Thesignaturebelowconstitutestheapprovalofthisprotocolandtheattachments,andprovidesthenecessaryassurancesthatthistrialwillbeconductedaccordingtoallstipulationsoftheprotocol,includingallstatementsregardingconfidentiality,andaccordingtolocallegalandregulatoryrequirementsandapplicableU.S.federalregulationsandICHguidelines.
TheLeadPI,thePIsfromallparticipatingclinicalsitesandotherkeypartiesshouldsignthesignaturepageasappropriate.
Signed:
Date:
Name
Title
StatementofCompliancei
SignaturePageii
ListofAbbreviationsvi
ProtocolSummaryviii
1KeyRoles1
2BackgroundInformationandScientificRationale3
2.1BackgroundInformation3
2.2Rationale3
2.3PotentialRisksandBenefits3
2.3.1PotentialRisks3
2.3.2KnownPotentialBenefits3
3Objectives4
4StudyDesign5
5StudyPopulation7
5.1SubjectInclusionCriteria8
5.2SubjectExclusionCriteria8
6Enrollment/Randomization/MaskingProcedures9
7StudyProcedures/Evaluations10
7.1ClinicalEvaluations10
7.2ConcomitantMedications/Treatments10
7.3LaboratoryEvaluations11
7.3.1ClinicalLaboratoryEvaluations11
7.3.2SpecialAssaysorProcedures11
7.3.3SpecimenPreparation,HandlingandShipping11
7.4Substudies12
8StudySchedule13
8.1Screening13
8.2Enrollment/Baseline13
8.3Follow-up14
8.4FinalStudyVisit14
8.5EarlyTerminationVisit14
9StudyIntervention/InvestigationalProduct15
9.1StudyProductAcquisition15
9.1.1Formulation,PackagingandLabeling15
9.2ProductStorageandStability15
9.3Preparation,AdministrationandDosageofStudyIntervention/InvestigationalProduct15
9.4AccountabilityProceduresfortheStudyIntervention/InvestigationalProduct(s)15
9.5AssessmentofSubjectCompliancewithStudyIntervention/InvestigationalProduct16
10AssessmentofScientificObjectives(e.g.,SafetyorImmunogenicityorEfficacy)17
10.1SpecificationoftheAppropriateOutcomeMeasures17
10.1.1PrimaryOutcomeMeasures17
10.1.2SecondaryOutcomeMeasures17
10.2MethodsandTimingforAssessing,Recording,andAnalyzingAppropriateOutcomeMeasures17
10.3ModificationandDiscontinuationofStudyIntervention/InvestigationalProductforaParticipant17
10.3.1Dose/ScheduleModificationsforaSubject17
10.3.2CriteriaforDiscontinuationofStudyIntervention/ProductforWithdrawalofaSubject(oraCohort)18
11AssessmentofSafety19
11.1SpecificationofSafetyParameters19
11.2MethodsandTimingforAssessing,Recording,andAnalyzingSafetyParamete
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- DMID Protocol Template