SDSP 20 November 2014 Meeting Minutes
From PHUSE Wiki
- Review sub-group progress and discuss next steps.
- Michael Brennan
- Tony Chang
- Beate Hientzsch
- Jane Lozano
- Nick Naro
- Pam Ryley
- Linda Simonsson
- Michael reiterated that he would like the plan should be 'smart' in that there are drop-down boxes with a list of values, links between the sections, and the capability to query, sort, and sub-set.
- Michael and Jane discussed the progress of the sub-groups:
- 1) List of Clinical and Non-Clinical Studies: Michael has been meeting with the sub-groups. The list will use consistent terminology and will utilize controlled terminology as much as possible. The list should include all studies. He will be meeting with this sub-group within the next week or two.
- 2) Pooled Analysis: Pam has created tables with metadata about pooled analysis that has the linking and drop-down boxes.
- 3) Standards & Controlled Terminology: The group has had several meetings and the information is
- 4) Legacy Data Conversion: Jane has received 2 different responses from 2 FDA representatives in regards to the Legacy Data Conversion Plan that is being developed. The plan could be part of the Study Data Standardization Plan or a separate plan. Michael will discuss with the Steering Committee.
- By the time of the PhUSE meeting in March of next year, this working group should have a draft template and supporting documents. There should be break-out sessions during the meeting and a presentation to the Steering Committee.
- Jane started on the creation of a template for this plan and shared it with the group.
- The group discussed where the plan template should reside - On the FDA data standards site or within PhUSE? Also, the drop down boxes will need to be maintained but how and who will do it needs to be addressed.
- [Jane] Send email to Michael regarding the section of the plan that discusses legacy data conversion. Michael will discuss with the Steering Committee on November 21st if time permits.
- [Jane] Schedule next group meeting in December.