Questions concerning the milestones

[Patrick Blandin]

Hello,
I have some difficulties about these 3 points

• For the artifact 06.02.03 why the milestones are “10 Final Report / Clinical Study Report Approved” instead of “11 ongoing” at center level because all these documents must be available during the trial (see ICH reference 8.3.8)?
• For the artifact 06.01.12, the milestone is “10 Final Report / Clinical Study Report Approved” at trial level, would you please explain to me why?
• Some other artifacts are linked to some ICH reference 8.2, 8.3, 8.4; in this case the reference model milestones must correspond respectively to the Start-up (#1,#2,#3), Study conduct (#4, #5, #6 #7) and close out (#8, #9, #10), but it’s not always the case. Why this inconsistency? If we follow only the milestones, are we in agreement with the ICH?
Thank you for your answers

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