NINDS Protocol Template.docx

NINDS Protocol Template.docx

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NINDSProtocolTemplate

FULLPROTOCOLTITLE

（Ifnotobviousfromtheprotocoltitle,consideraddingasubtitlethatbrieflysummarizesthetrial,suchas:

Arandomized,placebo-controlled,double-masked,2100-subjectclinicaltrialofXinthetreatmentofZ.）

StudyChair:

（ListStudyChair’sname,degree,positionandaffiliation）

Supportedby:

TheNationalInstituteofNeurological

DisordersandStroke（NINDS）

（Includeapplicationorgrantnumber（s）whenavailable）

StudyInterventionProvidedby:

（Nameofpharmaceuticalcompanyordevicemanufacturer,ifany,providingsupport）

SponsorofIND（IDE）:

（Officialsponsor,i.e.,INDorIDEholder,ifany.IncludeIND/IDE#whenavailable）

（Anymodificationtotheprotocolshouldbeannotatedonthecoversheetorinanappendix.Theannotationshouldnotetheexactwordsthatarechanged,thelocationintheprotocol,thedatethemodificationwasapprovedbytheExecutiveCommittee,andthedateitbecameeffective.）

Version1

MonthDay,Year

TABLEOFCONTENTS

Page

CLINICALSITESPARTICIPATINGINTHESTUDY……………………………………...

STUDYTEAMROSTER…………………………………………………………………….….

PRÉCIS…………..……………………………………………………………………………….

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-naïve,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