Instructions Please use the form below to submit your abstract for consideration. PLEASE MAKE SURE TO PRESS THE SUBMIT BUTTON AT THE BOTTOM OF THE FORM. You should receive a confirmation message after successful submission. Call for Abstracts Abstracts Due: Wednesday, 31 May 2023 In recognition of this being our inaugural CDISC TMF Interchange, we are waiving all Speaker Fees. Theme: The Evolution of the TMF Reference Model Initiative We are looking for innovative abstracts for the 2023 CDISC US TMF Interchange on any of the topics listed below. We are very keen to have different types of sessions such as fireside chats, debates, panels, interactive sessions, case studies and of course presentations. TMF RM Becoming a Standard What does it mean for the TMF RM to become a standard? How does it get there and stay there? How has following a standard affected other areas of clinical trials Beyond the TMF RM What else has come from the TMF RM Initiative and how have you used or developed it? What new areas should the TMF RM Initiative be tackling? Impact of Regulations How are the current and future regulations affecting TMF management such as ICH E6 R3, new device regulations, GDPR, EU CTR etc? Innovation in TMF Management What are the new advances in TMF technology? Is AI the answer? How are risk-based approaches changing the way technology is working? Is technology driving risk-based approaches? Are metrics and reporting driving innovation or the other way around... innovation driving metrics and reporting? Risk-Based Approaches What models for risk-based approaches are being used? How does this vary with different types of studies? Does a risk-based approach include the collection of less documentation in sponsor TMF and more authoritative source ISF verification? Will ICH E6 R3 drive a proportional TMF? TMF Interoperability How best is the eTMF system and others systems that hold TMF content need to work together? How can TMF become integrated as study management tool? What is the data flow in existing systems and what are the gaps? How do multi vendor systems compare to single vendor platforms? How does TMF link to eCTD and RIM, ICH M11 and Transcelerate DDF? Where does the Exchange Mechanism Specification fit in? TMF Culture and Engagement How do you match Generation Z’s immediate feedback requirements to the TMF management process ? How do you ensure business continuity in TMF management? What is the good, the bad, and the ugly of TMF culture? How do you change the perception of TMF? How do you engage all the TMF stakeholders? Back to Basics What is the TMF and the TMF RM and what is their history? Deep-dive into the artifacts and processes defining them? How do the different zones manage their documents? How has the TMF RM been implemented and why was it so successful? Why are completeness, timeliness and quality the basic necessities? Sponsor – CRO Co-operation How do Sponsors and CROs work together? How can joint inspections and audits benefit both parties? How have the models evolved? What about TMF records generated by vendors, for example central labs, depots, ePRO ? Inspections How do you bring together the TMF content including systems designated as TMF repositories besides the eTMF system? How do you support inspection requirements across all the various systems that are designated as TMF repositories? How is the TMF content viewed? Investigator Site Documents Where do Investigator Site documents fit in with the TMF RM – is there a big gap? What about Transcelerate initiatives and how does the TMF fit into them? What are the latest regulatory requirements for Investigator documents? What challenges do Investigative sites face? End of Study Challenges What do you do when a study ends? What archiving is really required for all of the designated TMF repositories? Is a distributed archival process really possible? Are there new, proven methods of how TMFs are transferred between Sponsors or from Sponsor to CRO/Vendor? Is the EMS being used? Contact Information First Name Last Name Additional Authors/Presenters Company/Affiliation Email Country - Select -AfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua And BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBolivia, Plurinational State OfBonaire, Sint Eustatius And SabaBosnia And HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (keeling) IslandsColombiaComorosCongoCongo, The Democratic Republic Of TheCook IslandsCosta RicaCôte D'ivoireCroatiaCubaCuraçaoCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland Islands (malvinas)Faroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-bissauGuyanaHaitiHeard Island And Mcdonald IslandsHoly See (vatican City State)HondurasHong KongHungaryIcelandIndiaIndonesiaIran, Islamic Republic OfIraqIrelandIsle Of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic OfKorea, Republic OfKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMacedonia, The Former Yugoslav Republic OfMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesia, Federated States OfMoldova, Republic OfMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State OfPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRéunionRomaniaRussian FederationRwandaSaint BarthélemySaint Helena, Ascension And Tristan Da CunhaSaint Kitts And NevisSaint LuciaSaint Martin (french Part)Saint Pierre And MiquelonSaint Vincent And The GrenadinesSamoaSan MarinoSao Tome And PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (dutch Part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia And The South Sandwich IslandsSouth SudanSpainSri LankaSudanSurinameSvalbard And Jan MayenSwazilandSwedenSwitzerlandSyrian Arab RepublicTaiwan, Province Of ChinaTajikistanTanzania, United Republic OfThailandTimor-lesteTogoTokelauTongaTrinidad And TobagoTunisiaTurkeyTurkmenistanTurks And Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVenezuela, Bolivarian Republic OfViet NamVirgin Islands, BritishVirgin Islands, U.s.Wallis And FutunaWestern SaharaYemenZambiaZimbabwe Abstract Submission Presentation Format - Select -Oral PresentationRoundtable Discussion General Topic General Topic - Select -TMF RM Becoming a StandardBeyond the TMF RMImpact of RegulationsInnovation in TMF ManagementRisk-Based ApproachesTMF InteroperabilityTMF Culture and EngagementBack to BasicsSponsor-CRO Co-operationInspectionsInvestigator Site DocumentsEnd of Study ChallengesOther… Enter other… Abstract Title Presentation Level - Select -BeginnerExpertBoth Abstract Upload paper (not required). After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract. PDF or DOC Upload One file only.30 MB limit.Allowed types: pdf, doc, docx. By checking this box, I agree to the speaker terms and conditions set forth in the abstract submission guidelines. All author(s) approve submitting this work for presentation. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation. The presenting author will be available to present the abstract if selected for the program. The presenting author will immediately notify CDISC if they are unable to present an abstract or if the presenting author changes. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community. If you register as an attendee but your abstract is later accepted as part of the program, we can adjust your registration to the speaker rate and issue a refund for the difference in price. WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION! Questions? If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org. Submit Leave this field blank