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==Agenda== | ==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: Unanymous | ||
− | == | + | ==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== | ==Adjournment== | ||
+ | Call adjourned at ~16:40 |
Revision as of 22:21, 27 September 2012
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: Unanymous
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