DMID Protocol Template.docx

DMID Protocol Template.docx

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DMIDProtocolTemplate

PREFACE

ThisdocumentistheDMIDprotocoltemplate,whichisrequiredfordevelopingDMID-sponsoredclinicalresearchprotocols.Notethatinstructionsandexplanatorytextareindicatedbyitalicsandshouldbereplacedinyourprotocoldocumentwithappropriateprotocol-specifictext.Sectionheadingsandtemplatetextformattedinregulartypeshouldbeincludedinyourprotocoldocumentasprovidedinthetemplate.

Thistemplateattemptstoprovideageneralformatapplicabletoallclinicaltrialsevaluatinganinvestigationalproduct.Wherespecificexamplesareprovided,theyareoftenfromthevaccinearea.

ReferquestionsregardinguseofthisprotocoltemplatetotheappropriateDMIDProtocolChampionorClinicalAffairsSpecialist.

TITLE

DMIDProtocolNumber:

DMIDFundingMechanism:

（e.g.,grant#,contract#）

PharmaceuticalSupportProvidedby:

（ifapplicable）

OtherIdentifyingNumbers:

INDSponsor:

（ifapplicable）

PrincipalInvestigator:

DMIDProtocolChampion:

DMIDMedicalMonitor:

DMIDClinicalAffairsSpecialist:

DMIDRegulatoryAffairsSpecialist:

（ifapplicable）

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

http:

//www.cancer.gov/clinicaltrials/learning/page3

∙NIHClinicalTermsofAward

SIGNATUREPAGE

Thesignaturebelowconstitutestheapprovalofthisprotocolandtheattachments,andprovidesthenecessaryassurancesthatthistrialwillbeconductedaccordingtoallstipulationsoftheprotocol,includingallstatementsregardingconfidentiality,andaccordingtolocallegalandregulatoryrequirementsandapplicableU.S.federalregulationsandICHguidelines.

TheLeadPI,thePIsfromallparticipatingclinicalsitesandotherkeypartiesshouldsignthesignaturepageasappropriate.

PrincipalInvestigator:

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