Drug/Bio Submissions

Latest Draft of EDM Sub Reference Model

2016-03-03 12:45:12 dgwyn

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:

http://edmrefmodel.com/download/edm-submission-reference-model-20-draft/

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Integration with TMF Reference Model

2015-01-07 11:24:38 dgwyn

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 StudieseCTD 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.

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Mind Map of Reference Model

2015-01-05 20:27:20 dgwyn

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.

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