NINDS Protocol TemplateWord文件下载.docx
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SponsorofIND(IDE):
(Officialsponsor,i.e.,INDorIDEholder,ifany.IncludeIND/IDE#whenavailable)
(Anymodificationtotheprotocolshouldbeannotatedonthecoversheetorinanappendix.Theannotationshouldnotetheexactwordsthatarechanged,thelocationintheprotocol,thedatethemodificationwasapprovedbytheExecutiveCommittee,andthedateitbecameeffective.)
Version1
MonthDay,Year
TABLEOFCONTENTS
Page
CLINICALSITESPARTICIPATINGINTHESTUDY……………………………………...
STUDYTEAMROSTER…………………………………………………………………….….
PRÉ
CIS…………..……………………………………………………………………………….
1.STUDYOBJECTIVES…………………………………………………………………...
1.1PrimaryObjective………………………………………………………….…………..
1.2SecondaryObjectives..………………………………………………………..………..
2.BACKGROUND……………………………………………………………………...…..
2.1Rationale………...…………………………………………………………………..…
2.2SupportingData……………………………………….………………………………
3.STUDYDESIGN……………………………………………………………...…………..
4.SELECTIONANDENROLLMENTOFSUBJECTS……………………...………….
4.1InclusionCriteria……………………………………………………………..………..
4.2ExclusionCriteria………………………………………………………………..…….
4.3StudyEnrollmentProcedures………………………………………………….………
5.STUDYINTERVENTIONS………………………………………………….………….
5.1Interventions,Administration,andDuration...……………………………….………..
5.2HandlingofStudyInterventions……………………………………………….………
5.3ConcomitantInterventions……………………………………………………….…….
5.4AdherenceAssessment………………………………………………………………...
6.CLINICALANDLABORATORYEVALUATIONS………………………………….
6.1ScheduleofEvaluations…………………………………………………….………….
6.2TimingofEvaluations………………………………………………………….………
6.3SpecialInstructionsandDefinitionsofEvaluations………………………….………..
6.4Off-InterventionRequirements………………………………………………….……..
7.MANAGEMENTOFADVERSEEXPERIENCES……...……………………...…….
8.CRITERIAFORINTERVENTIONDISCONTINUATION………………...……….
9.STATISTICALCONSIDERATIONS…………………………………………...……..
9.1GeneralDesignIssues………………………………………………………..………...
9.2Outcomes……………………………………………………………………...……….
9.3SampleSizeandAccrual……………………………………………………..………..
9.4DataMonitoring………………………………………………………………..……...
9.5DataAnalyses…………………………………………………………………...……..
10.DATACOLLECTION,SITEMONITORING,ANDADVERSEEXPERIENCE
REPORTING…………………………………………………………………………...
10.1RecordstobeKept………………………………………………………………..……
10.2RoleofDataManagement………………………………………………………..……
10.3QualityAssurance…………………………………………………………………...…
10.4AdverseExperienceReporting……………………………………………………..….
11.HUMANSUBJECTS……………………………………………………………..…….
11.1InstitutionalReviewBoard(IRB)ReviewandInformedConsent………………...…..
11.2SubjectConfidentiality…………………………………………………………..…….
11.3StudyModification/Discontinuation………………………………………….…..……
12.PUBLICATIONOFRESEARCHFINDINGS………………………………...……..
13.REFERENCES………………………………………………………………...………..
APPENDICES
I.
II.
III.MODELINFORMEDCONSENTFORM
CLINICALSITESPARTICIPATINGINTHESTUDY
Listthenameandaddressofeachparticipatingclinicalsiteinvestigator,includingtelephoneandfaxnumbersande-mailaddress.
STUDYTEAMROSTER
Listindividualswhoplaykeyrolesinthedevelopmentandexecutionofthestudy,especiallythosewhomayneedtobecontactedbythesitesduringthecourseofthestudy.Includeaddress,telephone,faxande-mailaddressofeachindividuallisted.
PRECIS
Thefollowingsectionsshouldprovideabare-bonesoutlineofapproximately1-2pages.
StudyTitle
Specifythefulltitle(andsubtitle,ifapplicable)ofthestudy.
Objectives
Specifytheprimaryandsecondaryobjectives.
DesignandOutcomes
Provideaverybriefdescriptionofthestudydesign(e.g.,multicenter,randomized,double-masked,PhaseIII),includingtheoutcomevariablesfortheprimaryand,ifapplicable,secondaryobjectives.
Usebriefoverviewdiagramhere,ifapplicable.ComplexdiagramsmaybeincludedinSection3,StudyDesign,instead.
InterventionsandDuration
Brieflydescribetheinterventionstobecompared.Indicatethetotallengthoftimeeachsubjectwillbeonstudy(interventionperiod+additionalfollowupoffintervention,asapplicable).
Abriefstatementaboutthescheduleandtypeofevaluationstobeperformedduringthestudymayalsobeincluded.
SampleSizeandPopulation
Brieflydescribethenumberandtype(patientpopulation)ofsubjectstobestudied.
Iftherandomizationwillbestratified,listthestratificationfactors.Iftherewillbeseparateobjectivesandoutcomevariablesforthestrata,listtheseintheappropriatesections(above).
1
STUDYOBJECTIVES
PrimaryObjective
Theprimaryobjectiveshouldalwaysbetoaddressaspecifichypothesis.Statethehypothesisinquantifiableterms;
e.g.,“theexperimentaltreatmentwillresultin12monthsofadditionalsurvivalcomparedtothecontroltreatment.”Forstatisticalpurposes,itmaybeworthwhiletostateboththenullandthealternativehypotheses.Thisprimaryobjectivemustmatchtheoneusedinsection9,StatisticalDesign.
SecondaryObjectives
Secondaryobjectivesmayormaynotbehypothesis-driven,mayincludesecondaryoutcomes,andmayincludemoregeneralnon-experimentalobjectives(e.g.,todeveloparegistry,tocollectnaturalhistorydata).
2Background
Rationale
Describethepatientpopulationtobestudiedandjustifyanyrestrictionsonthepopulation.Nameanddescribetheinterventionregimens,andjustifywhytheseparticularinterventionshavebeenchosen.Describeandjustifytherouteofadministration,dosageregimen,interventionperiod,etc.Spellouttheneed,relevanceandpriorityforthestudy.
SupportingData
Providethescientificandmedicaldata(e.g.,resultsofPhaseIandIIstudies)thatjustifiesthestudy,itsdesign,andtheinterventiongroups.
Summarizetheknownandpotentialrisksoftheinterventions.Fordrugstudies,packageinsertinformationcanbereferredto,butdoesnotneedtobeincludedunlessthereisanew,significantchange.JustifyanyaspectsofthestudynotFDA-approved(e.g.,differentdosingschedule,newcombinationofdrugs,newdrugformulation).
3STUDYDESIGN
Brieflydescribethestudydesignandindicate,ingeneralterms,howthedesignwillfulfilltheintentofthestudy.Usediagramstoexplaindesigncomplexities.
4SELECTIONANDENROLLMENTOFSUBJECTS
InclusionCriteria
4.1.1Thediseaseordisorderunderstudy,andhowitistobedocumented,i.e.,diagnosticmethods,criteriaforclassification,etc.
4.1.2Clinicalindicatorsofcurrentstatus,asmeasuredwithinXXdaysofrandomization.
4.1.3Priortherapy,ifany.Considerlistingspecificpriortreatments.Considerlistingtheallowabledurationofpriortherapyforthespecificpopulationtobestudied(e.g.,treatment-naï
ve,treatment-experienced,orprior-treatment-failed“salvage”subjects).
4.1.4Demographiccharacteristics(e.g.,gender,age)asapplicable
ExclusionCriteria
4.1.5Listspecificclinicalcontraindications.Specifygradesofsigns/symptoms.
4.1.6Clinica/laboratorylindicatorsofcurrentstatus,obtainedwithinXXdayspriortorandomization.Listthespecificteststobeperformedandthenarrowestacceptablerangeoflaboratoryvaluesforexclusion,consistentwithsafety.
4.1.7Specifyanyexclusionrelatedtopregnancy,lactation,orplanstobecomepregnant.Specifymethodsforassessingcurrentstatusandwillingnesstousecontraception,ifapplicable.
4.1.8Useof[excludeddrugs,devices,etc.]withinXXdayspriortostudyentry.
4.1.9Fordrugstudies:
Allergy/sensitivitytostudydrugsortheirformulations.
4.1.10Specifyanyclinical(e.g.,lifeexpectancy,co-existingdisease),demographic(e.g.,age)orothercharacteristicthatprecludesappropriatediagnosis,treatmentorfollow-upinthetrial.
4.1.11Activedrugoralcoholuseordependencethat,intheopinionofthesiteinvestigator,wouldinterferewithadherencetostudyrequirements.
4.1.12Seriousillness(requiringsystemictreatmentand/orhospitalization)untilsubjecteithercompletestherapyorisclinicallystableontherapy,intheopinionofthesiteinvestigator,foratleastXXdayspriortostudyentry.Listspecificillnessesandacceptabletime.
4.1.13Inabilityorunwillingnessofsubjectorlegalguardian/representativetogivewritteninformedconsent.
StudyEnrollmentProcedures
4.1.14Describethemethodforidentifyingandrecruitingcandidatesforthetrial.
4.1.15Describeproceduresfordocumentationofreasonsforineligibilityandfornonparticipationofeligiblesubjects.
4.1.16Describeconsent(andassent)procedures.
4.1.17Describetheprocedureforobtaininginterventiongroupassignment.
5STUDYINTERVENTIONS
Interventions,Administration,andDuration
Indicateeachstudyintervention,includinghowitisadministeredandtheschedule,aswellaspotentialsideeffects.Indicatewherethesubjectwillbetreated(e.g.,intensivecareunit).Stateguidelinesforuseofappropriatesupportivecaremedicationsortreatments.
HandlingofStudyInterventions
Describehowtheinterventionsaretobeacquiredbytheparticipatingclinicalsites(e.g.,thepharmaceuticalcompanywilldistribute