Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping Minutes 2016-05-05
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When: 2016-03-10, 14:00-15:00 EST
Next meeting: May 19, 2016 at 11:30 to 12:30 EST
Meetings: 2 week schedule
-Went through the paper paragraph by paragraph for ultra last comments
-White Paper reviewed and agreed upon.
-As paper is final in terms of the group, will forward to Phuse Leadership.
-As the paper is drawing a lot of attention, it was suggested that we should get the CDISC SEND leadership and FDA feedback on the white paper.
-Mike will distribute for their review and ask for comments within 3 weeks if possible.
|Mike||SEND final of white paper to PhUSE leadership as well as CDISC SEND leadership and FDA||Completed|
|Mike||Ask George for copy of the Visio image - visio file||Completed|
|Mike||Distribute draft to team for extra review||Completed|
|Craig||Take a shot at a second draft||Completed|
|Mike||Update Wiki||Next few days|
|Debra||Distribute Biomarker literature to group||Completed|
|Debra||Provide Phuse Leadership with the update from our working group||Debra provided|
|Group||Take question back to prospective organizations what a Biomarker is||Completed|
|Debra||Email Jerry Salyers about CDISC Biomarker team and their findings||Completed, received email back from Jerry|
|Mike||Upload the Scanned sheets of the group intent from Phuse CSS Meeting also CDISC definition of Biomarker||Next few days - Completed.|
|Group||Approach organizations to ask top 10 or 20 endpoints and a few odd balls in the biomarker arena and email to group||Almost Complete|
|Mike||Tabulate top 10 or 20 biomarkers from group||By next meeting - continue|
|Audrey||Get permission for many people from team to join Clinical Lab Team||Next meeting|
|Mike||Add Biomarker definition from FDA page.||Completed|
|Debra||Look into SDTM to see what other grouping qualifiers available||Completed|