2025 Europe Interchange Call for Abstracts - TMF Abstracts

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 see a confirmation page after successful submission.

 

2025 Europe Interchange Call for Abstracts - TMF Abstracts

Abstracts Due: Friday, 17 January 2025

We are looking for innovative TMF abstracts for the 2025 Europe Interchange on any of the topics listed below. We are very keen to have different types of sessions such as panels, interactive sessions, case studies and of course presentations. Please note that only one speaker will get the speaker rate when two or more speakers are nominated.  

 

Version 4: TMF RM Becoming a Standard to Support a Digital TMF

  • What does it mean for the TMF RM to become a standard and what are the potential challenges to all parties?
  • What are the implications of a digital TMF?
  • How will a company move to version 4?
  • How has following a standard affected other areas of clinical trials?

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?

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?
  • How are they validated?
  • Are metrics and reporting driving innovation or vice versa - innovation driving metrics clinical trials?
  • 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?
  • 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 / Vendor 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 and Audits

  • 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?
  • 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?

TMF Strategy

  • What is your overall TMF strategy – insourcing or outsourcing?
  • What influenced your strategic decision?

 

OTHER TMF RM STANDARDS TOPICS

You are welcome to submit an abstract on any TMF Reference Model experience, its implementation and associated planning. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.  CDISC is an open and multidisciplinary standard which interfaces with many areas and we are eager to hear about your experiences working with standards.

Contact Information
Abstract Submission
General Topic

Upload paper (not required).

After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract.

One file only.
30 MB limit.
Allowed types: pdf, doc, docx.
Submission Guidelines:
  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. I acknowledge that if I am unable to present and fail to notify the planners and my session chair in a timely fashion, this may affect my ability to present at future CDISC Interchanges.
  4. 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.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. 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.
  7. If, after confirming their participation in the Interchange, the author(s) are unable to present due to extenuating circumstances, the author(s) should first attempt to determine and notify their session chair and planners of an appropriate replacement.

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.

I confirm that I am submitting this abstract as TMF content for the Europe Interchange.