1. Test Submission Forum Goals of the project Project status: for example
Increase the number of test submissions FDA receives
Identify the barriers
Propose ways to overcome the barriers
Demystify the test submission process
Project status: for example
Completed
Recommend to close project
Contacts: Kathy Brown, and Dave Epstein,
Wiki site:

2. Test Submission Forum Milestones and Accomplishments
√ Conduct survey to determine the barriers
Two surveys conducted
Results posted on wiki site
A lot of questions surrounding the process
Looking for more detailed feedback about submissions
√ Develop “Wish list” for what should be included in test submission feedback:
FDA Reviewer comments
SDRG feedback
Indication if correct information is being included in the variable
Information on data loading success or issues
The version of validator(s) used during review
Data fitness checks
√ Develop list of questions/suggestions that could help demystify the process
Include diagrams (process flow) that details process from start to finish
Describe what the reviewer sees in their tools
Include commonly seen errors

3. Test Submission Forum Propose that this group be closed.
Milestones and Accomplishments (cont.)
√ Develop questions for eData at the CDISC SEND Fall F2F
√ FDA listened and heard concerns of the industry and proposed a Fit for Use Pilot (collaboration between CDISC and PhUSE)
Conclusion
The Fit for use Pilot addressed most of the wish list items
Team is waiting for the completion of the pilot to see if all major items identified within the team were addressed
Pilot results are still being shared, but there where no major gaps
Feedback provided within the pilot was/is much more useful than submitting a test submission
Wish list and recommendations are posted on the wiki page
Propose that this group be closed.