The latest draft of the EDM Submission Reference Model is available for review. This includes the latest content regarding prescribing information and also updates to the Regulatory / Administrative information. It can be downloaded at the link below:
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 126.96.36.199 to 188.8.131.52|
|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.
In an effort to modernize our delivery of reference model information, the team used techniques that we use in content management projects which include mind mapping techniques for visualization.
We have created a [wpdm_hotlink id=’88’ link_label=’mind map’] of the model available for download. The file was created using MindJet’s Mind Manager, however the file can be viewed and navigated without access to the software. All that is required is a PDF viewing tool.