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MnM Minutes CC 20120926
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M&M Conference Call 4:00PM Eastern Time (Date above)
Agenda
- Harmonization proposal from Wendy H.
- PSS from Kevin C.
Attendees
- Wendy Huang
- Austin Kreisler
- Lloyd McKenzie
- Jean Duteau
- Rob Hausam
Harmonization Proposal
Reviewed draft harmonization proposal posted to list by Wendy. Proposal is to update descriptions of 3 concept domains. Austin noted that one of the concept domains is deprecated. Not a reason to not improve the definition.
Motion: MnM endorses this proposal to go forward to harmonization. Move Wendy, second Austin: Unanimous
PSS Proposal
Kevin C. has asked MnM to endorse a PSS dealing with Detailed Clinical Models
Discussion:
- Committee found the text very long and confusing. The scope needs to be much more concise.
- At minimum, we have a concern about the proposal to create CMETs.
- Step 1 should indicate that the expected outcome is harmonization proposals
- We need clarity on exactly what MnM’s role will be and how DCM methodology is expected to be distinct from existing methodology for creation of v3 models.
- It also seems odd to have methodology covered last.
- We need more clarity in the proposal and then perhaps to hold a joint call before we could consider endorsing
Motion: Defer decision on endorsement until above issues are addressed. Austin/Jean: 3:0:1
Adjournment
Call adjourned at ~16:40
