The reports created by the 3 regional IRISS ETICS teams were written in such a way that the identity of participants is encoded. A single comprehensive report for each region was issued. These are now being made available to the public and can be viewed or downloaded below.
The ETICS Team invites developers of new tools or established vendors who are making major changes to their tools to use the materials provided here as a test bed for confirming the correct operation of these tools.
The sample eCTDs along with the detailed description of the intentional error in each sample and the expected outcome provides software developers with the resources they need to evaluate the compliance of their tools.
Sponsors may wish to use these same resources to test the tools that they currently use or perhaps are evaluating.
Links to Resources
|Region||Sample eCTDs||Phase 1 Report||Other|
|CA||CA Samples||CA Report & Sample Decode|
|EU||EU Samples||EU Report & Sample Decode|
|US||US Samples||US Report||US Sample Decode|