We are pleased to announce that the results from the annual TMF Survey have been analysed and the summary report can be downloaded for free HERE.
Some of the highlights that you can find in the report:
- Only 8% of respondents report NOT having an SOP for TMF Management.
- Although most TMF seem to contain a similar number of artifacts that are present in the TMF Reference Model, some report having over 800 artifacts listed.
- Whilst ICH GCP only mandates 5 documents being signed, some organizations require signatures on over 100 unique content types.
- Use of eTMFs continues to grow.
- Organizations using more than system for managing TMF content find problems with content reconciliation and end-users understanding where content is supposed to be.
- Minimal use of purpose-designed electronic archive solutions.
- Organizations are increasingly collecting cost metrics for TMF management.
- Higher numbers than previously using the TMF Reference Model without changes.
- 21% experiencing remote (off-site) inspections via an eTMF.