Transcription
Troubleshooting session for CTIS(Organisation Management Services)Session 1Presented by Débora Martins Braga in June 2022Master Data Manager – I-CS-RDMAn agency of the European Union
Agenda Questions raised Supporting documentation1OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Questions raised2OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Questions raised – summaryTroubleshooting questionsDataManagement31%Objective: clarify OMS relatedquestionsOrganisationname standards15%Location datastandards8%- 6 questions on Change request process- 4 questions on Data management- 2 questions on Organisation name standards- 1 question on Location data standards3OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines AgencyChange requestprocess46%
Questions raisedWho can change OMS data?Change RequestprocessSPOR NCA/IndustrySuper UserAnyone can change OMS data:- Using CTIS anyone can submit a Change Request tocreate organisation in the OMS Dictionary- Using OMS anyone can submit a Change Request tocreate and/or update organisation and/or locationpublished in the OMS Dictionary- As long as they submit supporting documentationValidation of data as per date of the Change Request4OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines AgencySPOR NCA/IndustryUser
Questions raisedChange RequestprocessHow to add/update OMS data?Add organisations- Add organisations- Update Organisation- Add Location- Update Location- Update Organisation &LocationUsing Change Request functionality available through:- CTIS to add organisations- OMS to add/update any organisation/location data- As long as submit supporting documentation is submittedValidation of data as per date of the Change Request5OMS – Organisation Management Services*document available on the OMS portalClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedCurrently it is not possible for Sponsor to registry several sites in OMS inparallel. Is it possible to add this function in OMS?Guest. With the right access, multiplechange requests can becreated in parallel:SPOR Industry/NCA User. for further information on CTIS access Via OMS multiple changerequests to add/updatemultiple records – limited to 1 pending change per record user needs tohave SPOR Super User or SPOR User access6Unaffiliated. Search Content view Via CTIS multiple changerequests to add neworganisations can besubmitted while preparing anapplication please consult HandbookOMS – Organisation Management ServicesChange RequestprocessRequire to request role in EMA AMApproved by Super UserExport informationCreate/Update ANY record – noneed to be affiliated to that samecompanyClassified as internal/staff & contractors by the European Medicines Agency Automatic with new EMAaccounts created Export information ONLY Request Neworganisation 1 request at a timeSPOR Industry/NCA Super User. Require to request role in EMA AM Approved by EMA – affiliation letterneeded At least 2 Super Users perorganisation Export information Create/Update ANY record – no needto be affiliated to that same company
Questions raisedOur investigational site is registered twice in OMS under different namessame addresses. How can we merge this 2 entries?Change RequestprocessOMS DataQualityattributes*AccuracyWhen potentialduplicated records areidentified by userSubmit a Change requestvia OMS portal to one ofthe records and use thejustification field to adda brief comment, includingthe ORG-ID of thepotential duplicateReflects reality?Help us assure high levelofData QualityUniquenessOnly instance?ConformityData standardised?ConsistencyConflicting information?CompletenessDetails missing?7OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency*Further information available on the OMS portalunder A4 - OMS Introduction - Webinar 10 March 2022
Questions raisedHow can we have/register locations that are not available in the Nationalbusiness register?OMSChange RequestprocessOMS Dictionary can have as manySource: OMS webinarlocations as used by an organisation1. Add Organisation with location detailsavailable in the Business registry2. Add other locations details required forregulatory procedures8OMS – Organisation Management Services If a certain physical address is beingused by another ORG, we need to createa new location (new relationship)ORG LOC Location (LOC ID) can only be linkedto one organisation Physical address can be linked to asmany organisations as neededClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedChange RequestprocessWhich organisation type should be entered when creating an EthicCommittee (e.g. health care or Regulatory Authority)?All category values are available on OMS Controlled Vocabulary*document available on the OMS portale.g. create an Ethic CommitteeSubmissionRequest to add an organisation use Level 1 category whenpopulating the form9OMS – Organisation Management ServicesValidationEMA adds Level 2 categoryClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedWhen providing information on the registration/update OMS differentiateamong the following groups: Pharmaceutical companies, CROs, Academia.How should sites be recorded?OMSData managementRegulatory roles, such as sponsors andsites are NOT maintained in OMSSource: OMS webinarOMS categorise organisations for the typeof activities10OMS – Organisation Management ServicesCategoryConsumingsystemOMSHospital XSite or ManufactureL1 Health careL2 Hospital/Clinic/Other healthcare facilityUniversity YSponsor or Site orMAHL1 Educational InstitutionCompany ZSponsor or MAH orManufactureL1 IndustryL2 Pharmaceutical companyCompany WCRO or Sponsor orMAHL1 IndustryL2 Pharmaceutical companyClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedShould the PI (name and surname and title) be registered in OMS or onlythe site where he/she works?Data managementOMSSource: OMS webinarIndividuals areNOT maintained in OMSIndividuals or PIdetails will need to becapture at consumingsystem level11OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedWhat is the extent of information entered for each clinical trial site (e.g.Hospital details only, or also Department details, Investigator details)?Data managementOMSSource: OMS webinarPublic entities not available on theNational business registry, such asHospital/University/Institutes willbe created and maintained in OMS asa legal entity, OMS will NOT capture:12OMS – Organisation Management Services-Department details-Units/Specialities information-Investigator detailsClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedAn organisation (i.e. Ethic Committee) registered in OMS may be changingthe legal name or legal entity identification. Can data be modified retainingthe Original ORG-ID or should a new organisation be registered?OMS managesorganisations as legalentities, we will maintainthe data according to theinformation available in theNational business registryData managementChanges available inthe Nationalbusiness registry?or valid source - applicable toentities not registered with theNational business registryYesNoAssessment need to be case by caseSame ORG IDName change, Business merge,Business acquisitions13OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines AgencyNew ORG ID
Questions raised(1/2) We're still having difficulty getting OMS values amended to theregistered name (national registry is incorrect), will these issues be reexamined/addressed?The OMS provides a single source of validatedorganisation/location data that can be used as areference to support EU regulatory activitiesOMS reflects equivalent information as the Business registry, it is not meantto be the same/“copy” of Business registryOrganisation name- Title case, except EEAorganisations where a casesensitive format exist14OMS – Organisation Management ServicesLegal entity- Country specific- Apply standardisationClassified as internal/staff & contractors by the European Medicines AgencyOrganisation namestandards
Questions raised(2/2) We're still having difficulty getting OMS values amended to theregistered name (national registry is incorrect), will these issues be reexamined/addressed?Organisation namestandardsExampleAccording to Indian Ministry ofCorporate Affairs (NationalBusiness registry), onlyAUROBINDO PHARMA LIMITEDis registered, hence we can’tcreate a separate ORG ID for eachManufacture Unit15OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedOMS values to the registered name (the ES national registry is beingincorrectly interpreted by the EMA change control analysts). Specifically,S.L vs S.L.U?Organisation namestandardsWhat is happening?We have a placeholder in KUG for furtherassessment – discussion will need to take placebetween KUG members, Spanish NCA and legalteamsExampleUntil further discussions, we will continueusing stablished rules/standards Spanish Business registry does NOT recognise Unipersonalas a valid Spanish legal entity type Certain organisations have a unipersonal “status/classification”when accessing extract from Spanish Business registry OMS uses the Spanish Business registry as reference sourcewhile mastering the data OMS cannot “translate” between i.e. S.L. vs S.L.U. as theyhave different meanings (not the same legal entity type)16OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Questions raisedWe're still having difficulty getting OMS values amended to the registeredname (national registry is incorrect), will these issues be re-examined?Location datastandardsSupporting documentation, RegistryThe OMS provides a single source ofvalidated organisation/location data thatcan be used as a reference to support EUregulatory activitiesSupporting documentation, GMPcOMS reflects equivalent information as the Businessregistry, it is not meant to be the same/“copy” of BusinessregistryNational Postal ServiceNational postal service, OMSOMS/AddressDoctor – populated withNational Postal Service detailsStandardise and enrich location data17OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
Supporting documentaiton18OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines Agency
SPOR documents & help1. Reference documents accessible from the SPOR portal– OMS web user manual – guidance on SPOR services, e.g. searching, exporting data, requesting CRs– SPOR user registration manual (how to register for SPOR)– SPOR affiliation template (to register the first industry super user)– Change Request Validation in OMS– Organisation data quality standards in OMS– SPOR SLAs (SLA are indicative and will be reviewed in future)– OMS FAQs2. Training videos5. SPOR related information & documentson EMA corporate websiteOMS training videos available to view on the@emainfo channelPrevious webinar https://youtu.be/bqOZEJ8AvW44. EMA Account Management PortalTo create a new EMA account in order to obtain access toEMA systems (including SPOR). To request SPOR user role.Account Management Portal.*Dedicated webinar in the morning, recording will be madeavailable in due course19OMS – Organisation Management Services3. EMA Service Desk PortalService requests, issues, requests for technicalsupport shall be submitted through theService Desk Portal.Classified as internal/staff & contractors by the European Medicines Agency
OMS mapping exerciseInformationReferenceSourcesData in OMSImpact/Process for mappings & CRsOrganisationnameInformation from:1. Trade registry2. DUNS3. Official docs (e.g.GMP certificates) OMS reflects an equivalentOrganisation name andlegal entity as the Traderegistry (or otherdocuments/sources) whichhas been Standardisedaccording to OMS DQrulesQ1. Is the Org name/legal entity in OMS the same as to Traderegistry? Yes - map No – see next questionNational Postalservices viaAddressDoctor OMS should reflect anequivalent legal addressas the Trade registry (orother documents/sources)which has beenStandardised according toNational Postal Services OMS can containadditional addresses forthe Organisation notreflected in the TradeRegistry but available inother references. Thesewill also be standardisedaccording to NationalPostal ServicesQ1. Is the location/address in OMS the same as to Trade registry? Yes - map No – see next questionLocation/Address details20OMS – Organisation Management ServicesQ2. Is the Org name/legal entity in OMS equivalent to Traderegistry i.e. same meaning but standardised according to OMS DQrules? Yes – map – if a CR is submitted it will be rejected No – submit CR & attach TR copyQ2. Is the location/address in OMS equivalent to Trade registry i.e.same meaning but standardised according to OMS DQ rules(AddressDoctor)? Yes – map – if a CR is submitted it will be rejected No – submit CR & attach TR copyQ3. Is the location/address in OMS not listed in Trade registry but inanother doc and equivalent to another reference source i.e. samemeaning but standardised according to OMS DQ rules (AddressDoctor)? Yes – map – if a CR is submitted it will be rejected No – submit CR & attach reference copyClassified as internal/staff & contractors by the European Medicines Agency
OMS mapping exercise - Organisation name/legal entityReferenceSourcesData in OMSCaseImpact/Process for mappings &CRsCompany A Ltd.Company A Ltd.Org name/legal entity in OMSthe same as to Trade registryMap dataCompany A Ltd.Company A LimitedOrg name/legal entity in OMSequivalent to Trade registry i.e.same meaning but standardisedaccording to OMS DQ rulesMap data – if a CR is submitted it will berejected (even if OMS is not a copy/exactmatch of TR!)Org name/legal entity in OMSNOT equivalent to Trade registrySubmit CR & attach TR copyCompany A Ltd.21Company A Inc.OMS – Organisation Management Services(see also other examples in equivalentdoc!)Classified as internal/staff & contractors by the European Medicines Agency
OMS mapping exercise - Location/Address detailsReference SourcesData in OMSCaseImpact/Process for mappings & CRsRua da Amargura, 12300-286LisbonPortugalRua da Amargura, 12300-286LisbonPortugalLocation/address in OMS the same asto Trade registryMap dataR. Amargura 12300-286LisbonPortugalRua da Amargura, 12300-286LisbonPortugalLocation/address in OMS equivalentto Trade registry i.e. same meaning butstandardised according to OMS DQ rules(AddressDoctor)Map data – if a CR is submitted it will be rejectedRua da Amargura, 12300-286LisbonPortugalRua da Amargura, 1Mouraria2300-286LisbonPortugalLocation/address in OMS equivalentto Trade registry i.e. same meaning butenriched according to OMS DQ rules(AddressDoctor)Map data – if a CR is submitted it will be rejectedRua da Amargura, 12300-286LisbonPortugalRua da Amargura, 22300-286LisbonPortugalLocation/address in OMS NOTequivalent to Trade registry i.e.different meaning, different physicalplaceSubmit CR to create new location & attach TR copyRua da Amargura, 12300-286LisbonPortugalRua da Amargura, 12300-300LisbonPortugalLocation/address in OMSequivalent/NOT equivalent to TraderegistrySubmit CR to update location & attach TR copy22OMS – Organisation Management ServicesNote: Requires verification with National postalservice but even if equivalent the TR determines ifthey are legally differentNote: Requires verification with National PostalService- If same physical location we update the postalcode- If is a different physical location we create newlocationClassified as internal/staff & contractors by the European Medicines Agency
OMS mapping exercise - Location/Address detailsReference SourcesData in OMSCaseImpact/Process formappings & CRsRua da Amargura, 21-232300-286LisbonPortugalRua da Amargura, 212300-286LisbonPortugalLocation/address in OMS equivalent toTrade registry i.e. same meaning butstandardised according to OMS DQ rules(AddressDoctor)Map data – if a CR is submitted it willbe rejectedRua da Amargura, 21-232300-286LisbonPortugallocation/address in OMS equivalent toTrade registryMap dataAnd Rua da Esperanca, 134300-500PortoPortugaladditional location/address not reflected inthe Trade Registry but available in otherreferencesAndRua da Amargura, 232300-286LisbonPortugalRua da Amargura, 21-232300-286LisbonPortugal23OMS – Organisation Management ServicesClassified as internal/staff & contractors by the European Medicines AgencyAdditional location present in OMS canbe added to the NCA/Industrydatabases for completeness purposes
OMS mapping exercise - Location/Address detailsReference SourcesData in OMSCaseImpact/Process formappings & CRsRua da Amargura, 21-232300-286LisbonPortugalRua da Amargura, 212300-286LisbonPortugalLocation/address in OMS partiallyequivalent to Trade registrySubmit CR to update location &attach TR copy.Rua da Amargura, 21-232300-286LisbonPortugalRua da Amargura, 21-252300-286LisbonPortugallocation/address in OMS equivalent toTrade registry additional location/address not reflected inthe Trade Registry but available in otherreferences24OMS – Organisation Management ServicesNote: address data verified accordingto information provided byAddressDoctor.- If not recognised by AD & EU countrya new loc will be created- If not recognised by AD & Non-Eucountry the loc will be updatedClassified as internal/staff & contractors by the European Medicines AgencySubmit CR to update location &attach TR copy.Note: address data verified accordingto information provided byAddressDoctor.- If not recognised by AD & EU countrya new loc will be created- If not recognised by AD & Non-Eucountry the loc will be updated
OMS mapping exercise - Location/Address detailsExamples on multiple doors addresses - NLReference SourcesData in OMSCaseImpact/Process for mappings & CRsKeizersgracht 62-64Amsterdam1015 CSNetherlandsKeizersgracht 62-64Amsterdam1015 CSNetherlandsLocation/address in OMS the same as to TraderegistryMap dataKeizersgracht 62/64Amsterdam1015 CSNetherlandsKeizersgracht 62-64Amsterdam1015 CSNetherlandsLocation/address in OMS equivalent to Traderegistry i.e. same meaning but standardisedaccording to OMS DQ rules (AddressDoctor)62-64 KeizersgrachtAmsterdam1015 CSNetherlandsKeizersgracht 62-64Amsterdam1015 CSNetherlandsLocation/address in OMS equivalent to Traderegistry i.e. same meaning but standardisedaccording to OMS DQ rules (AddressDoctor)Keizersgracht 62-64Amsterdam1015 CSNetherlandsKeizersgracht 62-64AmsterdamNoord-Holland1015 CSNetherlandsLocation/address in OMS equivalent to Traderegistry i.e. same meaning but enriched accordingto OMS DQ rules (AddressDoctor)Keizersgracht 62Amsterdam1015 CSNetherlandsKeizersgracht 63Amsterdam1015 CSNetherlandsLocation/address in OMS NOT equivalent toTrade registry i.e. different meaning, differentphysical placeKeizersgracht 62Amsterdam1015 CSNetherlandsKeizersgracht 62Amsterdam1015 CTNetherlandsLocation/address in OMS equivalent/NOTequivalent to Trade registry25This applies for the odd numbersMap data – if a CR is submitted it will be rejectedThis applies for the odd numbersMap data – if a CR is submitted it will be rejectedThis applies for the odd numbersMap data – if a CR is submitted it will be rejectedThis applies for the odd numbersThis applies for opposite scenarioThis applies for the odd numbersOMS – Organisation Management ServicesSubmit CR to create new location & attach TR copyNote: Requires verification with National postal service but evenif equivalent the TR determines if they are legally differentSubmit CR to update location & attach TR copyNote: Requires verification with National Postal Service- If same physical location we update the postal code- If is a different physical location we create new locationClassified as internal/staff & contractors by the European Medicines Agency
OMS mapping exercise - Location/Address detailsExamples on multiple doors addresses - NLReference SourcesData in OMSCaseImpact/Process for mappings & CRsKeizersgracht 62Amsterdam1015 CSNetherlandsKeizersgracht 63-65Amsterdam1015 CSNetherlandsLocation/address in OMS NOT equivalent toTrade registry i.e. different physical place asAddresses contain multiple consecutive odd or evennumbersSubmit CR to create new location & attach TR copyKeizersgracht 61Amsterdam1015 CSNetherlandsKeizersgracht 62-64Amsterdam1015 CSNetherlandsLocation/address in OMS NOT equivalent toTrade registry i.e. different physical placeAs Addresses contain multiple consecutive odd oreven numbersSubmit CR to create new location & attach TR copyKeizersgracht 62-64Amsterdam1015 CSNetherlandsKeizersgracht 62Amsterdam1015 CSNetherlandsLocation/address in OMS partially equivalent toTrade registrySubmit CR to update location & attach TR copy.Note: address data verified according to information provided byAddressDoctor.- If not recognised by AD a new loc will be createdKeizersgracht 62-64Amsterdam1015 CSNetherlandsKeizersgracht 62-66Amsterdam1015 CSNetherlandsLocation/address in OMS equivalent to Traderegistry additional location/address not reflected in theTrade Registry but available in other referencesKeizersgracht 62Amsterdam1015 CSNetherlandsKeizersgracht 62Amsterdam1015 CTNetherlandsThis applies for the odd numbersSubmit CR to update location & attach TR copy.Note: address data verified according to information provided byAddressDoctor.- If not recognised by AD a new loc will be createdThis applies for the odd numbers26Location/address in OMS equivalent/NOTequivalent to Trade registryThis applies for the odd numbersOMS – Organisation Management ServicesData Quality Rule in NL:- Addresses can contain multiple consecutive odd or even doors numbers- Addresses can not contain multiple non- consecutive doors numbers- Odd or even doors number is displayed at the end after the street name- Doors numbers are separated by hyphen with no space- Postal code has 4 digits and 2 capital lettersSubmit CR to update location & attach TR copyNote: Requires verification with National Postal Service- If same physical location we update the postal code- If is a different physical location we create new locationClassified as internal/staff & contractors by the European Medicines Agency
Any questions?Next OMSTroubleshootsession21 July 2022For CTIS specificquestions:CTIS Bitesize Talk20 Jul 2022CTIS walk-in clinic22 Aug 2022Please submit questions prior to the next session via Slido (www.sli.do) by 14 July2022.For sponsor users, please use code: #CTISTSSponsor and for Member Statesusers, please use code: #CTISTSMS.Further informationContact us through Service DeskOfficial address Domenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAddress for visits and deliveries Refer to www.ema.europa.eu/how-to-find-usSend us a question Go to www.ema.europa.eu/contact Telephone 31 (0)88 781 6000Follow us on@EMA NewsClassified as internal/staff & contractors by the European Medicines Agency
13 OMS -Organisation Management Services An organisation (i.e. Ethic Committee) registered in OMS may be changing the legal name or legal entity identification. Can data be modified retaining the Original ORG-ID or should a new organisation be registered? Data management OMS manages organisations as legal entities, we will maintain
