Q: 2
A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy and safety of a new
blood thinner for prevention of secondary cardiac events. The stated endpoint is all-cause mortality
at 1 year. Which data element would be required for the efficacy endpoint?
Options
Discussion
D. similar question pops up in practice tests and the official CCDM guide. Date of death is what they need.
Honestly, this vendor has so many pointless distractors in their questions. Option D
Agree with those picking D. For an all-cause mortality endpoint, knowing the date of death lets you confirm if the event happened inside the one-year window. Without it, survival analysis isn’t possible. Makes sense?
D, Had something like this in a mock and D is what they wanted for all-cause mortality.
C/D? Looks like C is a trap since it's all-cause not cause-specific, but pretty sure D is what you actually need here.
D , that's the key data you need for timing all-cause mortality endpoints.
D imo, that's what similar exam practice and the official SCDM guide focus on.
Maybe C. If you want to confirm that deaths are really related to underlying cardiac issues for better accuracy (even in all-cause), cause of death could matter, especially if adjudication is part of the protocol. Not fully sure, anyone see a reason this couldn’t apply?
Similar practice questions and the official guide both highlight D for all-cause mortality endpoints. D
I picked C here. Since the question asks about "all-cause mortality," I figured knowing the cause of death would be central to confirming it's included. Makes sense for safety endpoints too, I think. Let me know if that’s off.
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