Paragon Solutions recently became a member of the OASIS organization to participate in the eTMF Standard Technical Committee. This committee aims to expand the work previously done on the DIA TMF Reference Model. The objective of this committee is to enable the electronic exchange of Trial Master File (TMF) documents, enabled by standard metadata. In order to define an optimal TMF metadata structure, I have begun to examine the questions a TMF must be able to answer. Our examination of questions will follow the Zones of the DIA TMF Reference Model. Keep in mind that the purpose of the TMF is to tell the story of how the clinical trial was conducted and to ensure that the trial complies with regulations.

ZONE 1 - Trial Management

  1. Where are all of the documents stored (in paper and electronically) for the trial? What is the system of record for each document?
  2. What was the start and end date of the trial, along with the key milestones?
  3. What documentation can you provide to show the oversight of the trial?
  4. Which SOPs and trial specific procedures were in effect during the conduct of the trial?
  5. How were subjects recruited into the trial?
  6. What were the key decisions and issues during the trial and how was communication about the issues managed?
  7. What information and source documents were monitored at each site in the trial?
  8. How was the safety of subjects in the trial ensured?
  9. Which journal articles were published after the conduct of the trial?
  10. How was the progress of the trial reported and managed?
  11. What information was conveyed to Investigators and site personnel about the trial?
  12. What aspects of the trial were audited and why?
  13. What Notes to File were written during the trial and why?
  14. What were the risks evaluated and managed during the conduct of the trial?
  15. Which vendors were involved in the trial, their role and how was oversight managed?
  16. Who was involved from the sponsor and CRO as trial team members? What was their role, start and end date?
  17. Where are the Curriculum Vitae and training records filed for the trial team members?
  18. What external committees were involved with the safety and adjudication for the trial? Who were the members of each committee/
  19. How were dose escalation decisions made? (If applicable)
  20. What trial kick-off meetings were held, where, who attended and what was presented?
  21. What materials were the trial team members trained on, who was trained, and when?
  22. What Investigator Meetings were held, where, who attended and what was presented?
  23. What other relevant meetings and correspondence was generated to support Trial Management activities?

Please join in the conversation by submitting your comments and thoughts.

Creating a Roadmap to Clinical Trial Efficiency