eProtocol: Creating and Submitting a Protocol - University of ...

eProtocol is the Key Solutions software tool used to manage the life of a protocol. For investigators, the eProtocol system allows for the creation of a ... UniversityHomepage / InstitutionalAnimalCareandUseCommittee / Training / eProtocol:Creatingandsubmittingaprotocol InstitutionalAnimalCareandUseCommittee eProtocol:Creatingandsubmittingaprotocol Thispagecontainslinksto3rdpartycontent.Ifyouexperienceanyissuesaccessingthecontent,pleasecontactIACUCstaff. eProtocolistheKeySolutionssoftwaretoolusedtomanagethelifeofaprotocol.Forinvestigators,theeProtocolsystemallowsforthecreationofaprotocolandtheroutingoftheprotocoltotheIACUCCommitteeforreview.Thefollowingdocumentprovidesinstructionsforcreatingaprotocolandsubmittingittothereviewcommittee. AccesseProtocol Protocolresponsetypes Inordertocompleteaprotocol,itisimportanttoknowthedifferentresponseoptionsavailableineProtocolandhowtousethem.TheoptionspresentedineProtocolincludethefollowing: BinocularIcons–forselectinganeProtocoluserfromtheexistingsetofactiveusers RadioButtons–forselectingoneofasmallsetofoptions TextFields–forprovidinganunstructuredresponse Dropdowns–forselectingoneoptionfromapredefinedlist Yes,No,N/AButtons–forprovidingaclear,succinctresponsetoaquestion CalendarIcons–forselectingadate AddButtons–foraddingitemstoastructuredlist Checkboxes–forselectingoneormoreresponsesfromapredeterminedset Attachments–foraddingapre-existingfiletotheprotocol GuidanceforusingeProtocol Asyoucompletetheprotocolscreens,pleaseprovideasmuchinformationaspossible.Ifatextfielddoesnotapply,pleaseenter“N/A”ratherthanleavethefieldblank. InordertouseeProtocol,yourbrowsermustallowpop-upsfromeProtocol.unr.edu.Fordetailsonallowingpop-ups,pleaseviewhowtoconfigureyourwebbrowsertoallowpop-upwindows.FirefoxandChromearethepreferredbrowsersforusingeProtocol. WhenusingeProtocol,donotusethebrowser’sforwardandbackwardarrowstonavigate.BecauseeProtocolisasecureapplication,usingtheforwardandbackwardarrowsresultsinasecurityviolation,anunrecoverableerror,andyouareloggedoutofeProtocol. AtthetopofseveralscreensisalinktotheUniversity'sIACUCwebsiteandalinktotheAnimalResourceswebsite.ClickingtheselinkswillopenanewbrowserwindowandcausetheeProtocolscreentominimizetoyourcomputertaskbar.BesuretolookfortheeProtocolscreeninthetaskbar. Creatingaprotocol FromtheInvestigatorHomescreen,clicktheCreateNewProtocolbutton. EntertheStudyTitle,clicktheIACUCFormradiobutton,andcompletethePrincipalInvestigatorinformation.Note:InthePrincipalInvestigator(PI)informationscreen,“mailcode,”refersthePI’scampusmailstop. Whendone,clicktheCreatebutton. Personnelinformationscreen Allprotocolpersonnelwillbeaddedviathisscreen(e.g.,PrincipalInvestigator,Co-PrincipalInvestigator,AdministrativeEditor,etc.). Note:Ifyouindicate“yes”forthequestion,“Workingwithanimalmodels?”youmustdescribeindetailtheexperience/trainingrelatedtothisspecificprotocolforthatindividual.Pleasebesuretofollowtheon-screeninstructions. OccupationalHealthSurveillanceSystem(OHSS)dateofclearancefield:AllprotocolpersonnelwhowillworkwithanimalsmusthaveanOHSSdateofclearance.Ifpersonnelwillnotworkwithanimals,enter00/00/0000tosatisfytherequireddatefield.PleaseviewtheOccupationalHealthSurveillanceSystemoverviewpageforfurtherinformation. TrainingDetailssection:ThissectionwillbeautopopulatedwithCITItrainingdata.Theuserdoesnotneedtopopulatethissectionthemselves. ToaddaCo-PrincipalInvestigator,click“Add.”Intheresultingpop-upscreen,usethebinocularicontolocatethedesiredindividual.CompletetheCo-PrincipalInvestigatorinformationfieldsandclick“Save”intheupperrightofthepop-uptoreturntothemainPersonnelInformationscreen. Completetheremainingsectionsofthescreen.Whendone,clicktheNextbuttonatthebottomofthescreen. Speciesscreen Speciesandstraininformationwillbecapturedhere. Atleastonespeciesmustbeadded.Click“Add”inthegreysectionthescreenlabeled,SpeciestobeUsed.TheSpeciestobeUsedscreenwillopen. NoteregardingtheStrainfield:Thestrainfieldonlyallowsfortheentryofonestrain.Ifmorethanonestrainwillbeused,astrainlistmustbeaddedtotheprotocollaterintheAttachmentssectionofProtocolInformationscreen.Thestrainlistmustincludethenameofthespecies,thenameofthestrain,andadescriptionofthestrainphenotype(ifany).Ifthereisnophenotype,pleasestate"none."Further,ifanamendmentismadetothestrain(s),theprotocolmustbeupdatedbyaddingtheupdatedstrainslisttotheprotocolintheAttachmentssectionofProtocolInformationscreen. Completeallsectionsofthescreen.Whendone,click“Save”atthetopofthescreentoclosethewindowandreturntotheSpeciesscreenwheretheaddedspecieswillbelisted.Editscanbemadebyclickingonthespecieslisting.Ifthereareadditionalspecies,click“Add”andrepeattheaboveprocess. Whendoneaddingallspecies,clicktheNextbuttonatthebottomoftheSpeciesscreen. Vetconsultscreen TheVetConsultscreenisnotamandatoryscreen.Avetconsultisnotrequired,butitisrecommendedforanyresearchresultinginaUSDAPainCategoryLevelaboveC. Enterthatnameoftheveterinarianandthedateofconsult. Whendone,clicktheNextbuttonatthebottomofthescreen. Categoriesofusescreen Collaboratinginstitutionsandsafetyconcernswillbeaddressedhere. Allquestionsmustbeansweredyesorno.Notethatanswering“Yes”willrequiretheinputofadditionalinformation.SomesectionsutilizeanAddfunctiontoprovidetheadditionalinformationonasub-screenwhilesomesectionsprovidetextfieldstoprovidetheadditionalinformation.Ifdirectedtoasub-screen,youwillneedtocompletethesub-screenandclick“Save”atthetopofthescreentoreturntothemainCategoriesofUsescreen. NoteregardingNameofCollaboratingInstitute:Whiletheinstitutionpicklisthastheoption“other”forwhichonecantheentertheinstitutionnameinacorrespondingtextfield(intheeventofamissinginstitution),thepreferenceisforthemissinginstitutionbeaddedtothepicklistforuse.Torequesttheadditionofaninstitution,pleasecontactIACUCstaff. NoteregardingFieldStudyorWildlifeStudy:AnynecessarypermitsmustbeattachedtotheprotocolusingtheAttachmentssectionoftheProtocolInformationscreenthatwillbevisitedlateronintheprotocolcreationprocess. Whendone,clicktheNextbuttonatthebottomofthescreen. Fundingscreen Here,youwilllistallfundssupportingthisprotocoliftheyaretobeusedforanimalprocurementintheeAnimalOrderingModule.Pleasenotethatifsponsoredfundsarelisted,thisprotocolmustbetheprotocolofrecordinWorkday. Click“Add”inthepertinentsectionsofthescreentoaddfunding.Asub-screenwillopentoenterthefundinginformation.Completethesub-screeninformationandclick“Save”atthetopofthescreentoreturntothemainFundingscreen. Whendone,clicktheNextbuttonatthebottomoftheFundingscreen. Protocolinformationscreens Thesescreenswillbeusedtoaddressprotocolinformationsuchasstudyobjectives,procedures,alternativestopainfulordistressfulprocedures,husbandry,andeuthanasia.Additionally,thereisanAttachmentssectionfortheuploadofprotocoldocumentssuchasastrainslistandfieldstudyorwildlifepermits. Rationalescreen Besuretoaddressallapplicablequestions.Ifanitemdoesnotapply,respondwithN/A. Whendone,clickthe“Next”buttonatthebottomofthescreentoadvancetotheProceduresscreen. Proceduresscreen Click“Add”toopentheProcedureDetailssub-screen. USDAPain/DistressCategory:Besuretoverifythatthecorrectcategoryislisted. Whendone,click“Save”inthegreyProceduresDetailbar.Whenthescreenrefreshes,youwillpotentiallyseefourbluetabsinthemiddleofthescreenlabeledProcedureDescription,PersonnelDetails,AnestheticRegimen,andOtherDrugsUtilized(thetabsthatappeardependupontheproceduredetails). ProcedureDescriptiontab:Completetheproceduredetails.Whendone,click“SaveProcedure”aboveintherightcorneroftheProcedureDescriptiontab.Thenclick“Next”justabove“SaveProcedure”toadvancetothePersonnelDetailstab. PersonnelDetailstab:Click“Add”toopenthePersonnelDetailssub-screen.Whenaddingpersonnel’spreviousexperienceand/ortrainingplan,youmustprovidespecificdetails.Whendone,click“Save”intheupperrightofthesub-screen.YouwillreturntothemainPersonnelDetailsscreen.Ifthereareadditionalpersonnel,repeattheprocessabovetoaddthem.Whenallpersonnelhavebeenadded,click“SaveProcedure”aboveintherightcornerofthePersonnelDetailstab.Thenclick“Next”justabove“SaveProcedure”toadvancetotheAnestheticRegimentab. AnestheticRegimentab:Completeeachsectionbyclicking“Add.”Asub-screenwillopentoenterthedetails.Whendonecompletingasub-screen,click“Save”intheupperright.WhendonecompletingtheAnestheticRegimentab,click“SaveProcedure”aboveintherightcorneroftheAnestheticRegimentab.Thenclick“Next”justabove“SaveProcedure.” OtherDrugsUtilizedtab:Click“Add”toopentheOtherDrugsUtilizedsub-screen.Completethedrugdetails,andwhendone,click“Save”intheupperrightofthesub-screentoreturntothemainOtherDrugsUtilizedscreen.AdvancetotheAlternativeSearchscreenbyclickingtheNextbuttonattheverybottomofthescreen. Alternativesearchscreen IntheAlternativeSearchscreen,theliteraturesearchforalternativestopainfulordistressfulprocedureswillbeaddressed. Iftheprotocoldoesnotinvolvepainfulordistressfulprocedures,clickthe“Thisprotocoldoesnotinvolvepainfulordistressfulprocedures”checkbox. Click“Add”toopentheSearchDatasub-screen.CompleteSearchDatasub-screenandclick“Save”atthetopofthescreentoreturntotheAlternativeSearchscreen. AddressanyremainingquestionsontheAlternativeSearchscreen.Note:TheAlternativesforCategoryEProceduresfieldwillbegreyedoutunlesstheprotocolinvolvesUSDAPainCategoryE. Whendone,clicktheNextbuttontoadvancetotheHusbandryscreen. Husbandryscreen Note:IftheUniversity'sAnimalResourcesstaffwillprovidethespecialcare,thePImusthavediscussedthecarewithDirector,LabAnimalMedicineandAttendingVeterinarian,BenWeigler.IfOARstaffwillnotprovidethespecialcare,thePImustindicatewhowillprovidethespecialcareintheSpecialHusbandryorCarefield. SpecialHusbandryorCarefield:Ifnospecialhusbandryorcareisnecessary,enter“N/A”inthisfield.IftheUniversity’sAnimalResourcesstaffwillprovidethespecialcare,thePImusthavediscussedthecarewithDirector,LabAnimalMedicineandAttendingVeterinarian,BenWeigler.IfOARstaffwillnotprovidethespecialcare,thePImustusethisfieldtoindicatewhowillprovidethespecialcare. Thehusbandryscreeninformationisaddressedinseparatesectionsofthescreen.If“None”isselected,thecorrespondingsectionwillinactivateandbecomegreyedout.Ifcompletinginformationforasection,besuretoclicktheSavebuttoninthatsectionbeforeadvancing. AddressthequestionsonthescreenandclicktheNextbuttontoadvancetotheEuthanasiascreen. Euthanasiascreen Completethismandatoryscreenevenifnoeuthanasiaistooccur.WhenyougettotheEuthanasiadetailssub-screen,youwillbeabletoselect,“Noeuthanasia,”astheprimarymethodeuthanasia. Click“Add”toopentheEuthanasiasub-screen. Ifnoeuthanasiaistooccur,select“Noeuthanasia”fromtheMethodofEuthanasiaPrimarypicklist,select“Other”fromtheMethodofEuthanasia(Secondary)picklist(enter“N/A”infieldprovided),andenter“N/A”intheDescribesecondarymethodfield. Enteranexplanationforwhytherewillbenoeuthanasia. Click“Save”atthetopofthescreentoreturntothemainEuthanasiascreen.Whendone,clicktheNextbuttontoadvancetotheAttachmentsscreen. Attachments Usethisscreentoattachanyprotocolsupportingdocumentationsuchasstrainslist,tables,diagrams,orothersupportdocuments.Pleasenameallattachmentsandreferencethosenamesintheappropriatenarrativesectionsoftheprotocol. Click“Add”toaddattachments.Selectthedocumenttypefromthepicklist,browseforthedocument,andnametheattachmentasappropriate.Click“Save”tocompletetheuploadandreturntothemainAttachmentsscreen.Repeattheaboveprocessifthereareadditionalattachments. Whendone,clicktheNextbuttonatthebottomofthemainAttachmentsscreentoadvancetotheGuidelinesscreen. Guidelinesscreen TheGuidelinesscreeniswherethePImustindicatetheiragreementtocomplywithallUniversityIACUCpoliciesapplicabletotheprotocol.  Click“MandatoryLetter”toopentheGuidelinessub-screen. YoumayviewtheUniversityIACUCpoliciesbyclickingtheNevadaBoxlinkonthescreen.NotethatinNevadaBox,therearetwopagesofpolicies. Next,clickeitherthe“IAgree”buttonor“RequestException”buttonNote:Ifrequestinganexception,pleaseproviderationaleinthefieldprovided. Click“Save”atthetopofthescreentoreturntotheGuidelinesscreen. Whendone,clicktheNextbuttontoadvancetotheCertificationsscreen. Certificationsscreen Here,thePImustcertifytheprotocol. Clickthecertificationcheckboxandclick“Next.” Checkforcompletenessscreen Afterclicking“Next”ontheCertificationsscreen,theCheckforCompletenessscreenwillappearaspop-upandeitherlistanyuncompletedscreensorindicatethattheprotocolformiscomplete. Clickonthelinksforanyuncompletedscreensandcompletethem. Whendone,clickontheblueCheckforCompletenesstabontheleftverticalmenu.EnsurethattheCheckforCompletenessEnsurescreennowindicatesthattheIACUCformiscomplete.OncetheIACUCformiscomplete,theCheckforCompletenesspop-upmaybeclosed. Submitformscreen ClickontheblueSubmitformtablocatedintheleftverticalmenu.TheSubmitformscreenwillappearasapop-up. Tosubmittheprotocol,click“Yes.”Uponsubmission,thePIwillreceiveanemailconfirmation.Astheprotocolmovesthroughthereviewprocess,thePIwillreceiveupdatesviaemail.Further,thestatusofaprotocolcanbeviewedfromtheInvestigatorHomescreen. Eventhistoryscreen Thisscreenprovidesahistoryoftheprotocoleventsaswellastheemailnotificationevents.Further,theprotocolandanyemailnotificationscanbeviewedfromthisscreen. Usersupport Forusersupport,pleasecontactIACUCstaff. CommitteeContactInformation Mailstop:0331 MailingAddress:1664N.VirginiaSt.,Reno,Nevada89557 Email: [email protected] Phone: (775)682-6571 Directory:Contact