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EpidemiologicSpecifications :V      a. D Subgroup: 0 HIV(+) x HIV()  0 $ $HighRiskHIV()  _Seroconverter_ $$ S     D No./Subgroup ______ L 0 x ______  0(x$x$______  0($($______.J $$     b. D DiseaseProgression: L  x 0  Rapid   ( Intermediate  Slow $$      D Immunologicallydefined x 0  ______   ( 0T$$______  0T$T$00$$______">0$0$ U     D Clinicallydefined  L 0 x 0x$x$______   ( 0T$$______  0T$T$00$$______f0$0$     c. D Serialspecimenswithexplicitlystatedcomparisons: 2   0  d. D Other:$$    2.0  SampleType:* 0 $$4 O  5  6YOY   7 n YԀSerum x 0 $ $4 O  5  6pZOZ   7 ZԀPlasma0($$0T($($4 TO  5  6I[O][   7 [Ԁ_PBMCs_0T$T$0$$4 O  5  6A\OU\   7 ~\Ԁ_PBMC_Ԁpelletv$$      D  p    4 O  5  6]O]   7 n ]Ԁ_CVL_**0 x 0x$x$4 O  5  6z^O^   7 ^ԀBcells0($$0T($($4 TO  5  6U_Oi_   7 _ԀHostDNA**T$T$  EY     D  p    Other  $$N$  Ԉ   @  0  0$$ % &ax*Specimenspreviouslythawedforotherinitiativeswillmostlikelybeshipped.Ifunacceptable,giveareasonbelow ! forrequiringspecimensnotpreviouslythawed.LeftovermaterialcannotbereturnedtotheNationalRepositorywithout r" priorapprovalfromstudyspecificEC.6 R#$$  @`0  0$$**AvailableonlyintheWIHS.IfHostDNAisrequested,pleasecompletetheDNA_biorepository_Ԁsamplerequestform +!G$ andensureyouhaveaddressedalloftheWIHSqualitycontrolrequirementsinyourconceptsheet.# &ax% %a#! %$$ `  3.  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NOTE: Afteryour ,'2 CollaborationConceptSheethasbeensubmittedelectronically,pleasesignandFAXthispageandthe _-{(3 coverpagetoJudyKonig(4109557587)..+)4 $ $ # &ax% zg# /*6   XkX% &ax&  NOTE: # &ax%X Xki#   i 3"0  Ifyouarerequestinglymphoblasticcelllines,theNIHAIDSResearchandReferenceReagentProgram Fb requiresallinvestigatorstoberegisteredpriortoreceivingsamples.Registrationmaterialsandinstructions / canbefoundontheReagentProgramwebsitelocatedat 4G |O  5  www.aidsreagent.org 6kOk  7k$$ "0  Adatafilecontaininglabresultsanda_codebook_Ԁofspecimensreceivedmustbesubmittedtotheappropriate  2 DataCenter(CAMACSorWDMAC)priortothereleaseofvisitdataforanalysis'i. $$  MACSONLY:   2  Ѐ"0  Conservationofspecimensisveryimportant.Pleasesaveallleftoversamples.Pleaseadd2columnstothe I e  datafile.Thefirstcolumnshouldbethenumberofthaw/freezecycles.The2ndcolumnshouldhavethe  2  amountin%Lofspecimenused.  $$ Ѐ"0  Oncethespecimenisthawedsothatsamplescanbetakenfortesting,pleasefreezeremainingspecimen.2 $$ Ѐ"0  Shipremainingspecimensto:Ie $$  &j3:jH(X8"8"(Kevin_Kunstman_ |  NorthwesternUniversityMedicalSchool Tp  303E.Superior ,H _Lurie_Ԁ9-220   Chicago,IL60611  Phone:(312)908-2538 |  Fax:(312)908-2528 Tp   ,H ;pHIp58"8"XWp5    '% &axD.0  INTERNALCOLLABORATIONSONLY# &ax% 'br# 0$$   1.0  NEW_SUBSTUDIES_  % &ax(detailanyanticipatedadditionalparticipantandMACS/WIHSstaffburden(intermsof  amountoftimerequired,additionalvisits,specimenstobecollected,etc.))# &ax% Gs#$$   2.0  RELEVANCE  % &ax(tooverallMACSand/orWIHSaimsandjustificationforuseofMACS/WIHSspecimens)# &ax% t#Pl"$$   3.0  COREGOALS (DiscussionofconsistencywithMACS/WIHScoregoalsandscope.Proponentsof  % ConceptsareencouragedtolinkwithMACS/WIHSinvestigatorstoavoidoverlapwithongoing !& initiatives.Pleasereviewthefileslistedat4CshO  5  http://statepiaps.jhsph.edu/wihs/admin/conceptsheet "' info/conceptsheetinfo.htm6qvOv  7CsvԀtoseeactiveconceptsheetsbyresearchtopicintheWIHS.)h#($$  '% &ax E.0  MACS/WIHSINFORMATION# &ax% 'w# '",$$   1.0  MACSand/orWIHSLiaison: x ( $.$$   2.0  Institution: 2*N%0$$   3.0  FAXNumber: 0 $$0 $ $0L $ $0xL$L$v+&2x$x$   4.0  EmailAddress: ,'4$$ mx  5.0  MailingAddress: -)6$$   .)7 &     6.0  CAMACS/WDMACPointPerson:$$   0  TelephoneNumber: 0L$$0xL$L$0x$x$0$$(410)9554320or6141340$$   0  FAXNumber:  0 $$0L $ $0xL$L$0x$x$0$$(410)9557587or6147125$$   0  MailingAddress:  0L$$0xL$L$0x$x$0$$JohnsHopkinsUniversityl$$      D  p 0 0 $ $0 $ $0 $ $0L $ $0xL$L$0x$x$0$$BloombergSchoolofPublicHealthD`$$      D  p 0 0 $ $0 $ $0 $ $0L $ $0xL$L$0x$x$0$$DepartmentofEpidemiology 8$$      D  p 0 0 $ $0 $ $0 $ $0L $ $0xL$L$0x$x$0$$615NorthWolfeStreet,RoomE7644 $$      D  p 0 0 $ $0 $ $0 $ $0L $ $0xL$L$0x$x$0$$Baltimore,MD212051999 $$ 'z&i%% &ax NOTE# &ax%%&i#: 0 D EmailcompletedConceptSheetinaWord,WordPerfect,PDForRTFfiletoJoanaRoeatNIH T p  (4~ O  5  jroe@niaid.nih.gov6fOz%  7 " )forMACSandtoWDMAC(4 O  5  wdmac@jhsph.edu6<OP%  7 x~)forWIHS.Ifajoint 2N  collaborationtheConceptSheetmustbesenttoboth. & D$D$ $  '% &axPleasereadtheGuidelinesonthefollowingpages# &ax% 'Ϙ#  B^ @&( '% &ax Guidelines # &ax% 'Q#Ԉ X   A.0  GeneralInstructions D$$  TheMACS/WIHSCollaborationConceptSheetisintendedforuseforallcollaborations,whethertheinitiativeis  tocombinedatafrombothstudiesorforjustoneofthestudies.SectionsBandCarestudyspecificprotocolsfor t theconceptsubmissionandprocessing. L  *Uddd Xdd Xdd X$$, dd , dd +  / /IntendedStudy A,!L   AReadSections -#!L  " -MACS   `  BandD ! ` " !WIHS 0&$  0CandD 0&!$ " 0MACSand/orWIHS 0& 8  0B,C,andD1'% 8 "   1  B.0  ForresearchtobeperformedwiththeMACS: p $$  @   1.0  InvestigatorswishingtoaccessMACSdataorbiologicsamplesareencouragedtoreviewtheirproposed \ researchwiththeMACS.IfyoudonothaveaMACSliaison,contactNIHProjectOfficer,Robin_Huebner_ 4 at301402-4239or4 O  5  rhuebner@niaid.nih.gov6%O9her  7gforpossiblerecommendations.d $$   2.0  Internalinvestigator:reviewconceptsheetwithsitePI.Externalinvestigator:reviewconceptsheetwith P MACSliaisonandenterliaisonscontactinformationofpage2.($$   3.0  ProposalisassignedtoappropriateMACSWorkingGroupforreviewwithin2weeks.WorkingGroupmay l contactinvestigatorforfurtherclarificationorsuggestions.D$$   4.0  IfapprovedbyWorkingGroup,submitconcepttoJoanaRoe(seeSectionD)forpostingtotheweband  reviewbytheMACSExecutiveCommittee(EC).WorkingGroupchairnotifiesECthatitreceived ` preliminaryapproval.8$$   5.0  MACSECreviewswithin2weeksofposting,atwhichtimetheinvestigatormaybeaskedtoparticipatein |! aconferencecallforfurtherclarification.T"$$   6.0  TheinvestigatorwillbecontactedbytheECChairthattheconceptwasapproved,approvedwithcomments, $ tabledforfurtherclarification,needstoberevisedandreviewedagain,orrejected.p%$$   7.0  InvestigatorsneedingMACSdatawillneedtocompleteaDataUseAgreementFormandwillbecontacted  ' byCAMACSaftertheconceptsheethasbeenapproved.($$  ̊  8.0  PleasereviewtheMACSpublicationpolicyindepthafteryourCShasbeenapprovedlocatedat (!*  4O  5  http://www.statepi.jhsph.edu/macs/MACSpubpolicy.pdf6ГOher  7zԀ. "+$$   &  C.0  ForresearchtobeperformedwiththeWIHS: #\!-$$  Ԕ   1.0  ALLabstractsMUSTbesubmittedtotheWIHSECforreviewandapprovalbeforetheyaresubmittedto $"/ aconference.Also,ALLmanuscripts(includingsitespecific)MUSTbesubmittedtotheWIHSECfor %x#0 reviewandapprovalbeforetheyaresubmittedtoajournal.'#&P$1$$   2.0  PleasereviewtheWIHSpublicationpolicyindepthafteryourCShasbeenapprovedlocatedat '%3 L  M  L  M  L  M  L  M  L  M  L  M  4l0O  5  L  M  b  &ax%% &ax_https_://_statepiaps.jhsph.edu_/wihs/Investinfo/WIHS_ԄPubPolicy.pdf bT(  # &ax%%&ax#6%0  7 SL  M  (l&4$$  ln  3.0  UponConceptSheetapproval,aWIHSRepositoryRequestChecklistorWIHSDNA_Biorepository_ԀSample *'6 RequestForm(availableon4m O  5  b  L  M  L  M  L  M  L  M  L  M  L  M  L  M  b  _https_://_statepiaps.jhsph.edu_/wihs/indexinvestinfo.htm b  6p0  7 ______b0  )mustbefaxedto *(7 ChristineAldenat410-9557587,ifspecimensaretoberequested.+_)8$$   D.0  ForresearchtobeperformedwiththeMACSand/orWIHS: g-+:$$  מ   1.0  ForjointMACS/WIHSpublications,withthefirstauthorbeingacoinvestigatorofeitherstudy,thenumber .S,< ofcoauthorsshouldbe:1to3fromthe1stauthor'scenterandthe_analytical(CAMACS/WDMAC)center /+-= combined;andatotalof2to3fromstudyspecificsitescombined(e.g.,ColeSR,LiR,AnastosK,Detels X R,YoungM,Chmiel_JS_,_Muoz_ԀA.StatMed2003).0$$  o  2.0  Allpublicationsandpresentationsofstudiesutilizingsamplesand/ordatasuppliedbytheMACSand/or t WIHSshouldacknowledgeboththecontributionsofsamplesandtheMACSand/orWIHScollaboration L itself.Thesuggestedformforacknowledgmentis:$$$ H % &axDatainthismanuscriptwerecollectedbytheMulticenterAIDSCohortStudy(MACS)andtheWomen's | InteragencyHIVStudy(WIHS)CollaborativeStudyGroupwithcenters(PrincipalInvestigators)locatedat: @ MACScenters:TheJohnsHopkinsBloombergSchoolofPublicHealth(JosephMargolick);HowardBrown \   HealthCenterandNorthwesternUniversityMedicalSchool(JohnPhair,Steven_Wolinsky_);Universityof    California,LosAngeles(RogerDetels);UniversityofPittsburgh(CharlesRinaldo);andDataAnalysisCenter(Lisa    Jacobson).TheMACSisfundedbytheNationalInstituteofAllergyandInfectiousDiseases,withadditional  P  supplementalfundingfromtheNationalCancerInstitute;andtheNationalHeart,Lung,andBloodInstitute: l   UO1-AI35042,5M01RR00052(_GCRC_),UO1AI35043,UO1AI37984,UO1AI35039,UO1AI35040, 0  UO1AI37613,andUO1AI35041.   WIHScenters:NewYorkCity/BronxConsortium(KathrynAnastos);Brooklyn,NY(Howard_Minkoff_); `  WashingtonDCMetropolitanConsortium(MaryYoung);TheConnie_Wofsy_ԀStudyConsortiumofNorthern |$  California(Ruth_Greenblatt_);LosAngelesCounty/SouthernCaliforniaConsortium(AlexandraLevine);Chicago @  Consortium(_Mardge_ԀCohen);DataAnalysisCenter(StephenGange).TheWIHSisfundedbytheNational  InstituteofAllergyandInfectiousDiseases(U01AI35004,UO1AI31834,UO1AI34994,UO1AI34989, p UO1AI34993,andUO1AI42590)# &ax% F# % &axԀandbytheEuniceKennedyShriverNationalInstituteofChildHealthand 4 HumanDevelopment(UO1-HD32632).ThestudyiscofundedbytheNationalCancerInstitute,theNational P InstituteonDrugAbuse,andtheNationalInstituteonDeafnessandOtherCommunicationDisorders.Funding  isalsoprovidedbytheNationalCenterforResearchResources(_UCSF_Ԅ_CTSI_ԀGrantNumberUL1RR024131).  Thecontentsofthispublicationaresolelytheresponsibilityoftheauthorsanddonotnecessarilyrepresentthe D officialviewsoftheNationalInstitutesofHealth. ` # &ax% #*   3.0  ManuscriptsresultingfromcollaborativestudiesmustbereviewedbyMACSand/orWIHS  investigatorswhoarecoauthors.Sufficienttimeforrevisionshouldbeallowedbeforesubmission | toajournal.Finalrevisionsalsomustbeavailabletocoauthorsforreviewbefore_resubmission_.T""  ,  4.0  AcopyofallpublishedmanuscriptsshouldbesenttoJudyKonigtoprovideanarchivalrecord   ofworkresultingfromthestudy.AnadditionalcopyshouldbesenttoJoanaRoeat_NIAID_Ԁfor t! theMACSandtheWIHS. L""" S(  S"S"( % &axJoanaRoe T$ DivisionofAIDS % NationalInstitutesofHealth,_NIAID_ & Room4218,_MSC_Ԁ7626  H' 6700B_Rockledge_ԀDrive d! ( Bethesda,MD208927626 (") (301)4353759 " * JudyKonig T* CAMACS/WDMAC + JohnsHopkinsUniversity , BloombergSchoolofPublicHealth  H- 615N.WolfeStreet,RoomE7644 d! . Baltimore,MD21205 ("/ (410)9554320# &ax% # % &ax " 0 5S"S"  Sb5# &ax% g#S   5.0  IfdataanalysisforthemanuscripthasnotbeencarriedoutatCAMACSand/orWDMAC,thefirst t$"0 authorisresponsibleforsendingthecomputerprograms,finaldatasetsandcodebooksthatdirectly L%"1 relatetotablesandfiguresinthemanuscripttoCAMACS/WDMAC.Theprogramsanddatashould $ belabeledtable1.dat,table1._sas_Ԁ(ifSASwasused),etc.andshouldbesentalongwiththereprintsto &$3 JudyKonigatCAMACS/WDMAC.DatareceivedfromCAMACSandWDMACshouldbekept '|%4 confinedtothespecificaimsoftheanalysisproposed.Additionalinitiativesshouldbesubmittedto (T&5 theExecutiveCommittee(EC)viacompletionofanewCollaborationConceptSheetSubmission ),'6 Form.\*(7""   6.0  SpecimensordataprovidedbytheMACSandWIHSareintendedfortheexpresspurposeof +H)9 performingECapprovedresearch.Thesespecimensanddatamust not beprovidedtoother x, *: investigatorsorusedforadditionalprojectswithoutthewrittenconsentoftheMACSand/orWIHS T-*; ExecutiveCommittees.,.+<"" _  7.0  LeadauthorsshouldnotifyCAMACS/WDMACofanyandallmanuscriptsacceptedforpublication.p/->""     8.0  InternalInvestigatorsonly: Uponapprovalofaconceptsheet,authorsareexpectedtoupholdthe X followingtimeframe:4""     "0 D Assemblyofanalyticaldatasetshouldfollow0.5to1monthafterreceiptofrequest.Awriting x  groupwillbeassembledduringthistimeandyouwillbenotifiedofthemembership.Oneofthe P coauthorswillbethedesignatedcoauthorwhoshouldreceivecopiesofalldraftsandanalytic ( datasets.Thatauthorshouldbepreparedtostandinifyouareunabletocompletetheworkina  timelyfashion.D"D"     "0 D Preliminarystatistics,datavisualization,descriptions,explorationshouldbecomplete1to2    monthsafterCSapproval.  D"D"   0  "0D""Afocusedstatisticalanalysisaimedataddressingresearchquestions,includingdraftoffiguresand 8   tablestobeincludedinthepaper,wouldfollowwithinamonth.Atthispoint,coauthorsshould   besolicitedforinput. D"D"     "0 D Twoto3monthsafterCSapprovalreworkingofanalysesandwritingshouldbeinprocess.The ,  analystwillberesponsibleforhelpingtodraftmethodsandresults.Theleadauthorandcoauthors   areresponsiblefordraftingothercomponents.Bytheendofmonth3,afairlycompletedraft   shouldbecirculating.\D"D"     "0 D Threeto4monthsafterCSapprovalthedraftshouldberevisedwithinputfromcoauthorsin  preparationofthefinaldraft.xD"D"   0  "0D""Byendofmonth4thereshouldbeamanuscriptreadytosubmitforMACS/WIHSECapproval  andpublication.D"D"     0  Thistimeframeisdependentonmanyvariablesbutitisareasonabletarget.Theclearertheconcept 0 sheetisthefastertheprocess.Investigatorsshouldbewillingtobecontinuallyengagedwiththe  analyst.LeadauthorsareexpectedtokeeptheCAMACS/WDMACPointPersonapprisedofany  delaysintesting,analysis,writing,andmanuscriptsubmission.`""   9.0  Pleasereadthefollowing: InternalinvestigatorsshouldhavetheirConceptSheets(CS)reviewedby   thesitePI.ExternalinvestigatorsshouldhavetheirCSreviewedbytheircoinvestigatorliaison(as ! indicatedonpage2ofthisform)fromoneofthestudiestodeterminethatthisconceptsheetis X" appropriate.Ifnoliaisonexists,MACSCSshouldbesenttoJoanaRoeatNIH,DivisionofAIDSand 0# WIHSCSshouldbeemailedto4NO  5  wdmac@jhsph.edu6O   7 .`$""   10.0  Yoursubmissionindicatesthatyouagreewithalltheinformationonthepreviouspages(Internal L& Investigatorsonly)andthatyouhavereceivedlocalIRBapprovalfortestingtobeperformedatthe |$' timesamplesarerequestedfromtherepository.BoththeMACSandWIHSECwillreviewyourCS T ( forMACS/WIHScollaborativestudies.Studyspecificcollaborationswillbereviewedbythatstudy ,!) EC.YouwillbenotifiedofthestatusofyourCSviaemail.AfteryourCShasbeenreviewedbythe "* MACSand/orWIHSEC,youwillbesentanemailindicatingifithasbeenapproved,approvedwith " + comment,revisionrequestedorrejected.Additionally,approvedCSwillbeassignedaprojectnumber: #\!, _rYY_##(MACS)and/or_wYY_###(WIHS),whereYY=year.Youshouldusetheseproject#sinall $4"- correspondenceuptoandincludingpublication.d% #.""   11.0  ExternallyfundedinvestigatorsutilizingMACSand/orWIHSdataarerequestedtosendacopyoftheir &P$0 annualProgressReport(minusbudgetinformation)totherespectivestudy.'(%1""     0 D ForMACSrelatedprojectspleaseemailProgressReportsto4 YO  5  camacsms@jhsph.edu6kO   7 ormailto (l&3 addresslistedbelowandidentifytheleadinvestigatorandtitleaspresentedontheoriginal )D'4 ConceptSheetinyouremail/coverletter.t*(5D"D"    0  0D""0pD"D"0 p"p" % &axCAMACSJudyKonig+`)7 " "   0  0D""0pD"D"0 p"p"JohnsHopkinsUniversity,BloombergSchoolofPublicHealth|,$*8 " "   0  0D""0pD"D"0 p"p"615N.WolfeStreet,RoomE7644,Baltimore,MD21205# &ax% n#@-*9 " "     0 D InvestigatorswhouseWIHSspecimensordatainR01projectsarerequestedtosendacopyof .,; theirannualprogressreporttotheWDMACemailaccount:4 O  5  wdmac@jhsph.edu6O"   7 NP.