EudraLex - Volume 10 - Clinical trials guidelines

Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.A… Skiptomaincontent EuropeanCommission…PublicHealthMedicinalproductsEudralexEudraLex-Volume10EudraLex-Volume10-Clinicaltrialsguidelines Pagecontents Volume10ofthepublication"TherulesgoverningmedicinalproductsintheEuropeanUnion"containsguidancedocumentsapplyingtoclinicaltrials.AnumberofdocumentsinVolume10arebeingrevisedandupdatedtobringtheminlinewiththechangesrequiredbytheClinicalTrialsRegulation(EU)No536/2014.Additionally,newdocumentswerepreparedtocovernewaspectsintroducedbythesameRegulation.InordertomakeadistinctionbetweendocumentsapplicabletoclinicaltrialsauthorisedunderDirective2001/20/EC(i.e.thecurrentapplicabledocuments)anddocumentsrelevanttoclinicaltrialsauthorisedunderRegulation(EU)No536/2014,thesedocumentswillbelistedintwoseparatepagesontheEudralexVolume10website.UntiltheClinicalTrialsRegulationbecomesapplicablesponsorsshouldfollowthedocumentsrelevanttotheClinicalTrialsDirective.Duringthetransitionalperiod,whichwilllastforaperiodof3yearsstartingfromwhentheRegulationbecomesapplicable,bothsetsofdocumentswillapplyaccordinglyandshouldbereferredtorespectivelyaccordingtothelegislationunderwhichtheClinicaltrialisconducted.AttheendofthetransitionalperiodallclinicaltrialsshallbeconductedundertheRegulationandshouldfollowonlythesetofdocumentsapplicabletotheRegulation.Althoughitisnotmandatory,stakeholdersareencouragedtotakealreadyintoconsiderationanumberofaspectsthatareoutlinedintheneworupdateddocumentspublishedinthepagededicatedtotheClinicalTrialRegulationandapplythemtothoseclinicaltrialsauthorisedundertheDirective,totheextentpossibleandincompatibilitywiththelegalframeworkoftheDirective.SetofdocumentsapplicabletoclinicaltrialsauthorisedunderRegulationEUNo536/2014GuidanceonthemanagementofclinicaltrialsduringCOVID-19pandemicGuidancedocument(UPDATEDVERSIONv5-10February2022)SlidesofthewebinarabouttheGuidanceonthemanagementofclinicaltrialsduringtheCOVID-19pandemicWebinarabouttheGuidanceonthemanagementofclinicaltrialsduringtheCOVID-19pandemicChapterI-ApplicationandapplicationdocumentsPartIIapplicationdocumenttemplates Compensationfortrialparticipants-Template:PDF/WordHarmonisationguidance:PDFInvestigatorCurriculumVitaetemplate:PDF/WordDeclarationofinteresttemplate:PDF/WordSitesuitabilityform:PDF/WordInformedconsentandpatientrecruitmentproceduretemplate:PDF/WordCompliancewithapplicablerulesforbiologicalsamples:PDF/WordChapterII-SafetyreportingICHguidelineE2F-Noteforguidanceondevelopmentsafetyupdatereports(September2010)FormoreguidanceonsafetyreportingpleaserefertotheQ&AdocumentontheClinicalTrialsRegulationinChapterVChapterIII–QualityTemplateforthequalifiedperson'sdeclarationequivalencetoEUGMPforInvestigationalMedicinalProductsmanufacturedinthirdcountries:PDFversion-Wordversion(may2013)DetailedCommissionguidelineof8December2017onthegoodmanufacturingpracticeforinvestigationalmedicinalproductspursuanttothesecondparagraphoftheArticle63(1)ofRegulation(EU)No536/2014TemplateforIMPbatchrelease(applicableasfromthedateofentryintoapplicationofRegulation(EU)No536/2014onClinicalTrials)UnionBasicFormatforManufacturer'sAuthorisation(June2013)Guidelineontherequirementstothechemicalandpharmaceuticalqualitydocumentationconcerninginvestigationalmedicinalproductsinclinicaltrials(revision2 –January2022)Guidelineontherequirementsforqualitydocumentationconcerningbiologicalinvestigationalmedicinalproductsinclinicaltrials(Revision2-January2022)Auxiliarymedicinalproductsinclinicaltrials(rev.2,June2017)ChapterIV–InspectionsGuidancefortheconductofgoodclinicalpracticeinspections(August2017)AnnexI–toguidancefortheconductofgoodclinicalpracticeinspections–investigatorsite(September2017)AnnexII–toguidancefortheconductofgoodclinicalpracticeinspections–clinicallaboratories(August2017)AnnexIII–toguidancefortheconductofgoodclinicalpracticeinspections–computersystems(March2018)AnnexIV–toguidancefortheconductofgoodclinicalpracticeinspections–sponsorandCRO(August2017)AnnexVI–toguidancefortheconductofgoodclinicalpracticeinspections–recordkeepingandarchivingofdocuments(June2017)AnnexVII–toguidancefortheconductofgoodclinicalpracticeinspections–bioanalyticalpart,pharmacokineticandstatisticalanalysesofbioequivalencetrials(June2017)Guidanceforthepreparationofgoodclinicalpracticeinspections(August2017)Guidanceforthepreparationofgoodclinicalpracticeinspectionreportsandcommunicationofinspectionfindings(June2017)GuidanceforcoordinationofGCPinspectionsrequestedinthecontextofmarketingauthorisationapplicationsformutualrecognitionanddecentralisedproceduresandcooperationbetweenMemberStates(March2018)Note:TherevisionofAnnexVoninspectionsofphaseIunit,hasbeenputonholduntilfinalisationofthe“Guidelineonstrategiestoidentifyandmitigaterisksforfirst-in-humanandearlyclinicaltrialswithinvestigationalmedicinalproducts”nowpublishedontheEMAwebsite.Anupdatedversionofthedocumentwillbeprovidedinduecourse.ChapterV-AdditionaldocumentsAcceleratingclinicaltrialsintheEU(ACTEU)-DeliveringanEUclinicaltrialstransformationinitiativeQuestionsandAnswersDocument-Regulation(EU)536/2014–Version5(January2022)PleasenotethatcertainQ&Asandasectionofthisdocumentarestillbeingdiscussedwithintheexpertgrouponclinicaltrialsandarethereforenotyetincluded.Updatedversionsofthedocumentwillbepublishedprogressively.QuestionandAnswersontheinterplaybetweentheClinicalTrialsRegulationandtheGeneralDataProtectionRegulation(April2019) ThisdocumentwillberelevantwhentheClinicalTrialsRegulationbecomesapplicableexceptforquestion11whichexplainsthecurrentsituationundertheClinicalTrialsDirective.Guidelineonstrategiestoidentifyandmitigaterisksforfirst-in-humanandearlyclinicaltrialswithinvestigationalmedicinalproducts-EMEA/CHMP/SWP/28367/07Rev.1(July2017)Guidelineforgoodclinicalpractice-ICHE6(R2)-EMA/CHMP/ICH/135/1995(2016)Riskproportionateapproachesinclinicaltrials(April2017)SummariesofClinicalTrialResultsforLaypersons(version2-February2018)GoodLaySummaryPracticeGuidanceEthicalconsiderationsforclinicaltrialsonmedicinalproductsconductedwithminorsDetailedguidelinesongoodclinicalpracticespecifictoadvancedtherapymedicinalproducts–(Updatecurrentlyongoing)Recommendationonthecontentofthetrialmasterfileandarchiving–(Updatecurrentlyongoing)ListofnationalcontactpointsChapterVI–LegislationRegulation(EU)No536/2014oftheEuropeanParliamentandoftheCouncilof16April2014onclinicaltrialsonmedicinalproductsforhumanuse,andrepealingDirective2001/20/ECCommissionImplementingRegulation(EU)2017/556of24March2017ondetailedarrangementsforthegoodclinicalpracticeinspectionprocedurespursuanttoRegulation(EU)No536/2014oftheEuropeanParliamentandoftheCouncilCommissionDelegatedRegulation(EU)2017/1569(forlinguisticversions,clickhere)of23May2017supplementingRegulation(EU)536/2014oftheEuropeanParliamentandoftheCouncilbyspecifyingprinciplesandguidelinesforgoodmanufacturingpracticeforinvestigationalmedicinalproductsforhumanuseandarrangementsforinspections(applicableasfromthedateofentryintoapplicationofRegulation(EU)No536/2014onClinicalTrials)CommissionImplementingRegulation(EU)2022/20of7January2022layingdownrulesfortheapplicationofRegulation(EU)No536/2014oftheEuropeanParliamentandoftheCouncilasregardssettinguptherulesandproceduresforthecooperationoftheMemberStatesinsafetyassessmentofclinicaltrials(TextwithEEArelevance)SetofdocumentsapplicabletoclinicaltrialsauthorisedunderDirective2001/20/ECJointEC/EMA/HMAtechnicalnoticetosponsorsregardingcontinuouscompliancewiththeEUlegislationforclinicaltrialsfollowingthewithdrawaloftheUnitedKingdomfromtheEUGeneralinformation(July2006) ChapterI-ApplicationandapplicationformDetailedguidancefortherequestforauthorisationofaclinicaltrialonamedicinalproductforhumanusetothecompetentauthorities,notificationofsubstantialamendmentsanddeclarationoftheendofthetrial. Annex1revised:PDFversion-Wordversion(revision4ofNovember2009;updatedon22ofNovember2019).EudraCTVersion8.0usestheRevision4datedNovember2009oftheClinicalTrialsApplicationForm(updatedonNovember22,2019).FormoreinformationpleaserefertotheEudraCTwebsite.SubstantialAmendmentNotificationForm:PDFversion-Wordversion(revision3ofJune2010)DeclarationoftheEndofTrialForm:PDFversion-Wordversion(revision19ofJune2019)DetailedguidanceontheapplicationformatanddocumentationtobesubmittedinanapplicationforanEthicsCommitteeopinionontheclinicaltrialonmedicinalproductsforhumanuse(revision1ofFebruary2006)DetailedguidanceontheEuropeanclinicaltrialsdatabase(EUDRACTDatabase)(revisionofApril2004)ChapterII-SafetyreportingDetailedguidanceonthecollection,verificationandpresentationofadverseevent/reactionreportsarisingfromclinicaltrialsonmedicinalproductsforhumanuse("CT-3")ICHguidelineE2F-Noteforguidanceondevelopmentsafetyupdatereports(September2010)ChapterIII-QualityoftheinvestigationalmedicinalproductTemplateforthequalifiedperson'sdeclarationequivalencetoEUGMPforInvestigationalMedicinalProductsmanufacturedinthirdcountries:PDFversion-Wordversion(may2013)Goodmanufacturingpracticeforinvestigationalmedicinalproducts Goodmanufacturingpracticesformanufactureofinvestigationalmedicinalproducts(February2010)DetailedCommissionguidelineof8December2017onthegoodmanufacturingpracticeforinvestigationalmedicinalproductspursuanttothesecondparagraphoftheArticle63(1)ofRegulation(EU)No536/2014(applicableasfromthedateofentryintoapplicationofRegulation(EU)No536/2014onClinicalTrials)TemplateforIMPbatchrelease(applicableasfromthedateofentryintoapplicationofRegulation(EU)No536/2014onClinicalTrials)UnionBasicFormatforManufacturer'sAuthorisation(October2014)GuidelineontherequirementstothechemicalandpharmaceuticalqualitydocumentationconcerninginvestigationalmedicinalproductsinclinicaltrialsGuidelineontherequirementsforqualitydocumentationconcerningbiologicalinvestigationalmedicinalproductsinclinicaltrials(September2018)GuidanceonInvestigationalMedicinalProducts(IMPs)and"noninvestigationalmedicinalproducts"(NIMPs)(rev.1,March2011)ChapterIV-InspectionsGuidanceforthepreparationofGCPinspections(June2008)Recommendationoninspectionproceduresfortheverificationofgoodclinicalpracticecompliance(July2006)GuidancefortheconductofGCPinspections(June2008)AnnexItoGuidancefortheconductofGCPinspections-Investigatorsite(June2008)AnnexIItoGuidancefortheconductofGCPinspection-Clinicallaboratories(June2008)AnnexIIItoGuidancefortheconductofGCPinspections-Computersystems(June2008)AnnexIVtoGuidancefortheconductofGCPinspections-SponsorandCRO(June2008)AnnexVtoGuidancefortheconductofGCPinspections-PhaseIUnits(November2008)AnnexVItoGuidancefortheconductofGCPinspections-Recordkeepingandarchivingofdocuments(March2010)AnnexVIItoGuidancefortheconductofGCPinspections-Bioanalyticalpart,PharmacokineticandStatisticalAnalysesofBioequivalenceTrials(November2008)GuidanceforcoordinationofGCPinspectionsandco-operationbetweenGCPinspectors,thereferenceandconcernedMemberStatesandCMD(h),inthecontextoftheevaluationoftheGCPcomplianceofmarketingauthorizationapplicationsformutualrecognitionanddecentralizedprocedures(June2009)GuidanceforexchangeofGCPInspectionReportsaccordingtoArticle15(2)ofDirective2001/20/EC(revision1-May2009)GuidanceforthecommunicationonGCPinspectionsandfindings(June2008)ProcedureforstandardisationofGCPinspectionentriesinEudraCT(November2008)GuidanceforthepreparationofGoodClinicalPracticeinspectionreports(June2008)RecommendationsonthequalificationsofinspectorsverifyingcomplianceinclinicaltrialswiththeprovisionsofGoodClinicalPractice(July2006)ChapterV-AdditionalinformationGuidelineonstrategiestoidentifyandmitigaterisksforfirst-in-humanandearlyclinicaltrialswithinvestigationalmedicinalproducts-EMEA/CHMP/SWP/28367/07Rev.1(July2017)Guidelineforgoodclinicalpractice-ICHE6(R2)-EMA/CHMP/ICH/135/1995(2016)GuidelinesonGoodClinicalPracticespecifictoAdvancedTherapyMedicinalProducts(2019)Recommendationonthecontentofthetrialmasterfileandarchiving(July2006)"Questions&Answers"Document-Version11.0(May2013)Ethicalconsiderationsforclinicaltrialsonmedicinalproductsconductedwiththepaediatricpopulation: Originalversion(2008)Guideline2008/C168/02onthedatafieldsfromtheEuropeanclinicaltrialsdatabase(EudraCT)thatmaybeincludedintheEuropeandatabaseonMedicinalProductsListoffieldscontainedinthe"EudraCT"clinicaltrialsdatabasetobemadepublic,inaccordancewithArticle57(2)ofRegulation(EC)No726/2004anditsimplementingguideline2008/C168/02(June2019)Guideline2009/C28/01ontheinformationconcerningpaediatricclinicaltrialstobeenteredintotheEUDatabaseonClinicalTrials(EudraCT)andontheinformationtobemadepublicbytheEuropeanMedicinesAgency(EMA),inaccordancewithArticle41ofRegulation(EC)No1901/2006ListoffieldstobemadepublicfromEudraCTforPaediatricClinicalTrialsinaccordancewithArticle41ofRegulation(EC)No1901/2006anditsimplementingguideline2009/C28/01(June2019)Guidanceonpostingandpublicationofresult-relatedinformationonclinicaltrialsinrelationtotheimplementationofArticle57(2)ofRegulation(EC)No726/2004andArticle41(2)ofRegulation(EC)No1901/2006Technicalguidanceontheformatofthedatafieldsofresult-relatedinformationonclinicaltrialssubmittedinaccordancewithArticle57(2)ofRegulation(EC)No726/2004andArticle41(2)ofRegulation(EC)No1901/2006(January2013)EudraCT-ListofadditionalfieldscontainedinEudraCT(reasonsfornegativeopinionsoftheEthicsCommittee)(November2010)ChapterVI-LegislationDirective2001/20/ECOFtheEuropeanParliamentandoftheCouncilof4April2001ontheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMemberStatesrelatingtotheimplementationofgoodclinicalpracticeintheconductofclinicaltrialsonmedicinalproductsforhumanuseCommissionDirective2005/28/ECof8April2005layingdownprinciplesanddetailedguidelinesforgoodclinicalpracticeasregardsinvestigationalmedicinalproductsforhumanuse,aswellastherequirementsforauthorisationofthemanufacturingorimportationofsuchproductsCommissionDirective2003/94/ECof8October2003layingdowntheprinciplesandguidelinesofgoodmanufacturingpracticeinrespectofmedicinalproductsforhumanuseandinvestigationalmedicinalproductsforhumanuse(OJL262,14.10.2003,p.22-26) 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