SOP-12-Subject-Recruitment-Procedures

SOP12EN02SOP12–SubjectRecruitmentPage1of8©FondsdelarechercheensantéduQuébec,2006TitleSubjectRecruitmentCodeSOP-12No.ofPages8HistoryofValidatedVersionsDatedd/mm/yyyyVersionPagesDescriptionofChangeHistoryofSOPImplementationVersionDatedd/mm/yyyyVersionDatedd/mm/yyyyVersionDatedd/mm/yyyyApprovalofSiteSOPSignatureDatedd/mm/yyyySOP12EN02SOP12–SubjectRecruitmentPage2of8©FondsdelarechercheensantéduQuébec,2006TableofContents1.Policies2.Objective3.SiteResponsibilities3.1.ResearchCentreDirector3.2.Sponsor-InvestigatororInvestigator/QualifiedInvestigator3.3.PersonresponsibleforthesiteSOPs4.Procedures4.1.Generalities4.2.Methodsofrecruitment4.3.Recruitment4.4.RecruitmentReports5.References6.AppendixAppendix1–InstructionsSpecifictotheSite1.PoliciesWithintheframeworkoftheprinciplesinherentinGoodClinicalPractice(GCP)oftheInternationalConferenceonHarmonisation(ICH),thisstandardoperatingprocedure(SOP)describestheprocessofrecruitmentofsubjectsforaclinicalstudy.Itappliestoallclinicalstudiesinvolvinghumansubjectswhichtakeplaceintheinstitution.ThisSOPconcernsallinstitutionalpersonnelworkinginclinicalresearchandshouldbefollowedbyallthoseinvolvedinclinicalstudiesinvolvinghumansubjects.2.ObjectiveTheobjectiveofthisoperatingprocedureistodescribetheprinciplesthatgoverntheprocessofrecruitmentofsubjectsinaclinicalstudy.3.SiteResponsibilities3.1TheResearchCentreDirectororhisdelegateisresponsiblefor:3.1.1ApprovingorupdatingsiteSOPsthatwillbeusedintheinstitutionaccordingtointernalinstitutionalvalidationprocedures;3.1.2InformingmembersoftheEthicsCommitteethatthissiteSOPwillbeimplementedwithintheinstitution;3.1.3ImplementingandmanagingthissiteSOPwithintheinstitution;SOP12EN02SOP12–SubjectRecruitmentPage3of8©FondsdelarechercheensantéduQuébec,20063.2TheSponsor-InvestigatororInvestigator/QualifiedInvestigatorisresponsiblefor:3.2.1Ensuringthat,duringtheclinicalstudy,theresearchteam,whichwillbeunderhis/hersupervisionwillcomplywiththissiteSOP.3.3UnderthesupervisionoftheResearchCentreDirectororhisdelegate,thepersonresponsibleforsiteSOPsshould:3.3.1AtthetimeofimplementationofeachSOP,ensurethatclinicalstudypersonnelattheinstitutionaretrainedinproceduresandcomplywiththisSOP.IntheeventthatanSOPismodified,providetrainingforinstitutionalclinicalstudypersonnelregardingthechange(s)andensuretheircompliancewithanychanges.4.Procedures4.1Generalities4.1.1Theinvestigator/qualifiedinvestigatorshouldensurethatallpersonsassistingwiththestudyareadequatelyinformedabouttheprotocol,objectives,profileofthepopulationtoberecruited,investigationalproducts(s),biologicalproducts,medicaldevicesorradiopharmaceuticals,andtheirstudy-relatedtasksandfunctions,ICH4.2.4.ThetrainingoftheResearchTeamheldatthebeginningoftheclinicalstudyshouldbedocumented.Thisdocumentationshouldbekeptwiththedocumentsessentialtothestudy.4.1.2WiththegoalofassuringcompliancewithGCP(ICH4.2.4)andthisSOP,itisnecessaryfortheinvestigator/qualifiedinvestigatortodiscusswithmembersoftheresearchteam,theirresponsibilitieswithrespecttotheprocessofrecruitment.ItisrecommendedthatdelegationofresponsibilitiesregardingrecruitmentofsubjectstodesignatedmembersoftheresearchteambedocumentedintheTaskDelegationForm,reference:appendix2,SOP3.Thisdocumentshouldbekeptwithdocumentsessentialtothestudy.4.1.3CivilCodeofQuebec,L.Q.,1991,c64:Apersonoffullagewhoiscapableofgivinghisconsentmaysubmittoanexperimentprovidedthattheriskincurredisnotdisproportionatetothebenefitthatcanreasonablybeanticipated,a.20.1991,c.64,a.20.Aminororapersonoffullagewhoisincapableofgivingconsentmaynotbesubmittedtoanexperimentiftheexperimentinvolvesseriousrisktohishealthor,whereheunderstandsthenatureandconsequencesoftheexperiment,ifheobjects.Moreover,aminororapersonoffullagewhoisincapableofgivingconsentmaybesubmittedtoanexperimentonlyif,wherethepersonistheonlysubjectoftheexperiment,ithasthepotentialtoproducebenefittotheperson’shealthoronlyif,inSOP12EN02SOP12–SubjectRecruitmentPage4of8©FondsdelarechercheensantéduQuébec,2006thecaseofanexperimentonagroup,ithasthepotentialtoproduceresultscapableofconferringbenefittootherpersonsinthesameagecategoryorhavingthesamediseaseorhandicap.SuchanexperimentshouldbepartofaresearchprojectapprovedandmonitoredbyanEthicsCommittee.ThecompetentEthicsCommitteesareformedbytheMinisterofHealthandSocialServicesordesignatedbythatMinisteramongexistingresearchethicsboards;thecompositionandoperatingconditionsoftheCommitteesaredeterminedbytheMinisterandpublishedintheGazetteofficielleduQuébec.Consenttoexperimentationmaybegiven,inthecaseofaminor,bythepersonhavingparentalauthorityorthetutorand,inthecaseofapersonoffullageincapableofgivingconsent,bythemandatory,tutororcurator.Whereapersonoffullagesuddenlybecomesincapableofconsentandtheexperiment,insofarasitshouldbeundertakenpromptlyaftertheappearanceoftheconditiongivingrisetoit,doesnotpermit,forlackoftime,thedesignationofalegalrepresentative,consentmaybegivenbythepersonauthorizedtoconsenttoanycarethepersonrequires;itisincumbentuponthecompetentEthicsCommitteetodetermine,whenexaminingtheresearchprojec