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Posted On: 11/07/2022 6:01:09 AM
Post# of 148878
Quote:
A Quality Agreement should have been approved after the MSA. The Quality Agreement has more specific deliverables related to the integrity of the study and are aligned to ICH E6(R2) & 21 CFR Part 312 and are what the litigation typically focuses on (more so than the MSA) . Hopefully a Quality Agreement was drafted and approved between the two.
found here in the comments:
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
Does anyone know if such a document exists and if so, how to get a hold of it?
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