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March 6, 2020 at 11:51 am #2910
If included as an annex or supplement to the Trial Agreement, then I agree that 05.02.12 would be the most appropriate classification. You might also consider artifact 05.04.07 Financial Documentation. I’ve seen sponsors use this for trial budgets and payment summaries/reports. Remember that the filing level is for guidance only; if the Reference Model just has an “X” in the site column but an artifact covers the whole trial or just a specific country, there’s no problem filing at the trial level or country level, as appropriate.