2024 Europe Interchange Call for Abstracts - TMF Abstracts

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 see a confirmation page after successful submission.

We are also delighted to welcome posters. 

2024 CDISC Europe Interchange Call for Abstracts - TMF Abstracts

Abstracts Due: Friday, 12 January 2024

Theme: The Evolution of the TMF Reference Model Initiative

We are looking for innovative abstracts for the 2024 Europe Interchange on any of the TMF topics listed below. We are very keen to have different types of sessions such as panels, interactive sessions, case studies and of course presentations.

The TMF Reference Model as a Tool

• 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? How is TMF Health measured? What other TMF RM initiative outputs have been utilised? What are the unique ways of using the TMF RM e.g. real-world trials, Investigator initiated trials, decentralised trials?

TMF Reference Model Becoming a Standard

• What does it mean for the TMF RM to become a standard and what are the potential challenges to all parties? How does it get there and stay there? How has following a standard affected other areas of clinical trials?

Impact of Regulations

• How are the current and future regulations affecting TMF management such as ICH E6 R3, new device regulations, GDPR, EU CTR, data integrity etc?

Technology and Innovation in TMF Management

• What are the new advances in TMF technology? How can we leverage applications with AI and / or machine learning with confidence and compliance? Are metrics and reporting driving innovation or the other way around... innovation driving metrics clinical trials? How will the data driven approach change the TMF landscape? What are the concerns with cybersecurity and data integrity?

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? How are risk-based approaches changing the way technology is working? Can technology drive risk-based approaches? Academic Research on risk-based approaches?

TMF Interoperability

• How best do the eTMF and others systems that hold TMF content 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?

Sponsor – CRO Relationships

• How do Sponsors and CROs work together, including conflict resolution? How have the models evolved? How do they manage differing requirements? How can joint inspections and audits benefit both parties? 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 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 Exchange Mechanism Specification being used?

Other TMF Topics

• You are welcome to submit an abstract on any other TMF area. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.

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