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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?
