Today’s agenda for the EDM Submission Reference Model team includes a discussion on the overlap and integration between the EDM Submission and TMF Reference models. While the TMF model was spawned from the EDM team a number of years ago, the two models have evolved over time independently. We have discussed as a team the need for reviewing the overlaps and ensuring we are aligned between the two models.
An initial assessment has uncovered several areas that may be overlapping as shown in the table below:
TMF Ref Model | EDM Ref Model |
Site Signature Sheet | Signature of PI or Sponsor |
Interim Analysis Output Interim Analysis Raw Datasets Interim Analysis Program Interim Analysis Datasets |
Documentation of Statistical Methods and Interim Analysis |
Data Definitions for Analysis Datasets | Clinical – CSR – Datasets – Analysis Datasets – Data Definitions |
PK Report | Clinical – Human PK Studies – eCTD 5.3.3.1 to 5.3.3.5 |
Site Management – Protocol Deviation | Clinical – CSR – Appendices – Data Listings – Protocol Deviation |
Financial Disclosure Form | Financial Disclosure Cover Note |
Regulatory Meeting | Administrative – Administrative Information – Regulatory Meetings – General:
– Regulatory Meeting Agenda – Meeting Background Materials – Regulatory Meeting Presentation – Correspondence Regarding Meetings |
CSR Synopsis | Clinical – CSR – Synopsis |
Todays’ meeting will discuss an approach to addressing these potential overlapping areas.