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, kathryn.brown@sanofi.com and Dave Epstein, david.epstein@fda.hhs.gov Wiki site: http://www.phusewiki.org/wiki/index.php?title=Test_Submission_Forum_Group

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

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.