WPC N #August6,2003(3$ !     '  88_XTyXXX``0#____________________________ X ((*#CollaboratorsName > (3$ !  (O$,cAZArial U Hs/   X"  _ XTyXXX_EC_ԀApproved: 0  ___Yes___No%Date:  M X     ___Requestedadditionalinformation/revision#XTyXXXTy.#  ,cAZArial  x X"  _ &XTyXXX  ThecompletedStudyInvestigatorRegistrationFormshouldbesent  Ѐelectronically(eitheraWord,WordPerfect,PDForRTFfile)  to_Joana_ԀRoe(jroe@niaid.nih.gov)atNIH. #XTyXX&XTy.#,cAZ"Arial Regular  X"  _#XTyXXX_IRB_ԀApproval:  $XTyXX#XTy X Doesthisprojecthavelocal_IRB_Ԁapproval?  $&|%X$XTy򀀀Yes p 򀀀No YY  X #$XTyX%$&|#Timeperiodof_IRB_Ԁapproval:$&|%X$XTy   h   򀀀/򀀀/򀀀to򀀀/򀀀/򀀀   X #$XTyX%$&|#Local_IRB_Ԁreference#:$&|%X$XTy    h     A##&|%%$&|###XTyX%#&|#,cAZArial ,cAZArial ,cAZArial UUUU)!dxdx d(3$ !  (3$ !  _XW`TE<<CLevel 1Level 2Level 3Level 4Level 5($$   1    dcccc)!dxdx&p d Pdeeee)!dxdx&p Pd dghgh)!dxdx3+0 d d d3+0 d d daaaa)!dxdxrrrr)!dxdxP Pdtttt)!dxdx dvvvv)!dxdx drr)! dxdxyyyy)!dxdx&0 d d{{{{)!dxdx&P d d !  _,88X8dd8 XTyXXX@  PXXTySTUDYINVESTIGATORREGISTRATIONFORM X @h h FORCOLLABORATIONSWITHMACS#XTyXP#  X Date:  #SubmissionType: @ 򀀀Initial @H 򀀀Revised $ ..$#򀀀Letterneededforgrantsubmission }% LeadInvestigator: @  ##L# I  StudyTitle:   @      Institution:   @     TelephoneNumber:  U  FAXNumber: @   y! EmailAddress: @   E ShippingAddress: @         @       @  Allpublicationsandpresentationsofstudiesutilizingsamplesand/ordatasuppliedbythe [ MACSshouldacknowledgeboththecontributionsofsamplesand/ordataandtheMACS A collaborationitself.Thesuggestedformforacknowledgmentis: ' 88  f^2"`x  `E.,QttifO+!f8 4 DatainthismanuscriptwerecollectedbytheMulticenterAIDSCohort  Study(MACS)withcenters(PrincipalInvestigators)atTheJohns   HopkinsBloombergSchoolofPublicHealth(JosephMargolick, g! Alvaro_Muoz_);HowardBrownHealthCenterandNorthwestern  M" UniversityMedicalSchool(JohnPhair);UniversityofCalifornia,Los !3# Angeles(RogerDetels,BethJamieson);andUniversityofPittsburgh q" $ (CharlesRinaldo).TheMACSisfundedbytheNationalInstituteof W# % AllergyandInfectiousDiseases,withadditionalsupplementalfunding =$!& fromtheNationalCancerInstitute:UO1AI35042,5M01RR00052 #%"' (_GCRC_),UO1AI35043,UO1AI37984,UO1AI35039,UO1AI  &#( 35040,UO1AI37613,UO1AI35041.%  &$)44  88! '}%* /   ManuscriptsresultingfromcollaborativestudiesmustbereviewedbyMACSinvestigatorswho  arecoauthorsallowingsufficienttimeforrevisionbeforesubmissiontoajournal.Final  revisionsalsomustbeavailabletocoauthorsforreviewbefore_resubmission_.  TwocopiesofallpublishedmanuscriptsshouldbesenttotheCenterfortheAnalysisand j  ManagementoftheMulticenterAIDSCohortStudy(CAMACS)toprovideanarchivalrecord P ~ ofworkresultingfromthestudy.Anadditionalcopyshouldbesentto_Joana_ԁRoeforinclusion 6 d intheannualMACSPublicationsCompendium.  J  (h8#8#(&|%XXTy88_Joana_ԀRoe    DivisionofAIDS   NationalInstitutesofHealth   Room4258,_MSC_Ԁ7626 d  6700B_Rockledge_ԀDrive 8f  Bethesda,MD208927626  :  (301)4353759#XTyX%&|P#      &|%XXTyCAMACSJudyKonig   JohnsHopkinsUniversity  BloombergSchoolofPublicHealth   615N.WolfeStreet,RoomE7004 d  Baltimore,MD21205 8f  (410)9554320#XTyX%&|:#  :  8}8o58#8#h88(5  Iftheresearch/proposalrequiresspecimens,adatafilecontaininglabresultsofthese n specimensmustbesubmittedtoCAMACSpriortothereleaseofvisitdata.Ifdataanalysis T inthemanuscripthasnotbeencarriedoutatCAMACS,thefirstauthorisresponsiblefor :h sendingthecomputerprogramsandfinaldatasetsandcodebook(developedincollaboration  N withCAMACS)thatdirectlyrelatetotablesandfiguresinthemanuscripttoCAMACS.The 4 programsanddatashouldbelabeledtable1.dat,table1.sas(ifSASwasused),etc.Ifthere  arequestionsregardingformattingpleasecontactAlvaro_Muoz_Ԁ(afreeman@jhsph.edu)at  CAMACS.AdditionalinitiativesshouldbesubmittedtotheExecutiveCommittee(_EC_)through  _Joana_ԀRoe(jroe@niaid.nih.gov)atNIH.  SpecimensordataprovidedbytheMACSareintendedfortheexpresspurposeofperforming n _EC_Ԅapprovedresearch.Thesespecimensmust not beprovidedtootherinvestigatorsor T  usedforadditionalprojectswithoutthewrittenconsentoftheMACS_EC_.Datareceivedfrom @ n! CAMACSshouldbekeptconfinedtothespecificaimsoftheanalysisproposed. &!T"  NOTE: Priortothereleaseofdataand/orspecimenstoexternalinvestigators,notice #% of_IRB_ԀapprovalneedstobesenttoCAMACS(ljacobso@jhsph.eduor $& jscholle@jhsph.edu),ifnotalreadysuppliedonpage4ofthisform.  %' _}^I95h p  `@XTTTTE8|,h@(, }_  h("* @$ STUDYDESIGN   &|%XXTyUsethefollowingorganizationtopresentyourstudyplanandtakewhateverspaceisnecessaryto  completelyrespondtoeachsection.Completein12pointfontonly.#XTyX%&|H# x 'XTXX'A.  HYPOTHESESANDRATIONALE  F B.  SUMMARYOFPRELIMINARYDATA   C.  CONCISEDESCRIPTIONOFPROPOSEDEXPERIMENT(S) B D.  PROPOSEDDATEOFPROJECTCOMPLETION:     @  SAMPLESPECIFICATIONS   &|%XXTyTakewhateverspaceisnecessarytocompletelyrespondtoeachsection,usinga12pointfontonly.  #XTyX%&| #6XT, XXTX6E.  EPIDEMIOLOGICSPECIFICATIONS D r   1.  Subgroup: HIV(+) H HIV()  HighRiskHIV()  _Seroconverter_  >       No./Subgroup ______ H ______  ______  ______      2.  DiseaseProgression:   H Rapid    Intermediate  Slow         Immunologicallydefined H ______   P ______  ______ v        Clinicallydefined   H ______   P ______  ______ Bp    3.  Serialspecimenswithexplicitlystatedcomparisons <   4.  Other:  F.  SAMPLETYPE: Serum_____  Plasma_____0  Cells_____>l##          @  Other  ##L#  Ԉ  8 G.  SAMPLEQUANTITY:  Minimum:  ##L#  Ԉ !          @    Optimum:  ##L#  Ԉ n#!  NOTE: 󀀀Ifyouarerequestinglymphoblasticcelllines,theNIHAIDSResearchand  &N $ ReferenceReagentProgramrequiresallinvestigatorstoberegisteredpriortoreceiving  ':!% samples.RegistrationmaterialsandinstructionscanbefoundontheReagentProgramweb ' "& siteat www.aidsreagent.org . (#' _c^"/` p  `E8*http) ic_ 89898#8#  89898989  89898989  89898989  89898989  89898989  89898989 &/T).8989  @  DATASPECIFICATIONSANDSTATISTICALANALYSIS   &|%XXTyTakewhateverspaceisnecessarytocompletelyrespondtoeachsection,usinga12pointfontonly.  #XTyX%&|'#H.0  BRIEFSUMMARYOFRELEVANTEXPERIMENTALDATAD r## 0  (Includeunitsofmeasurementandrangeexpectedforeachvariable.Includehowdata * X willbereported:onpaper,whatdatabase,whatfilestructure?) >## I.  BRIEFSUMMARYOFPROPOSALTOANALYZEDATA   0  (WhatadditionalMACSdatamightbeneeded?Willyouneedanalyticsupportfromthe t  MACSdatacenter?Ifso,atwhatlevel?)Z ##    : @" MACSINFORMATION   MACSPointPerson:   Institution:   @   V  TelephoneNumber:  " P FAXNumber: @      EmailAddress: @     MailingAddress: @              @           @  CAMACSPointPerson:  h TelephoneNumber:   (410)9554320 4b FAXNumber: @    (410)9557587 . MailingAddress: @    JohnsHopkinsSchoolofHygieneandPublicHealth            @    DepartmentofEpidemiology !          @    InfectiousDiseaseProgram "           @    RoomE7004 ~#!          @    615NorthWolfeStreet d$"          @    Baltimore,MD212051999