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Posted On: 11/24/2020 12:37:14 PM
Post# of 148936
Is there a complication with how the data is locked and reported? I honestly don't know if it can be done in such a granular fashion...meaning...
- Can they lock and report a single patient's data that's completed the 42 days.
- Can they lock and report a single patient's partial data that's only completed 28 days but not 42 days.
I would think these scenarios could only be executed if they were written into the interim data analysis plan which might be part of the modified protocol. Not sure ad hoc data analysis can occur if it wasn't documented and approved beforehand.
Possibly the more experienced can chime in here.
- Can they lock and report a single patient's data that's completed the 42 days.
- Can they lock and report a single patient's partial data that's only completed 28 days but not 42 days.
I would think these scenarios could only be executed if they were written into the interim data analysis plan which might be part of the modified protocol. Not sure ad hoc data analysis can occur if it wasn't documented and approved beforehand.
Possibly the more experienced can chime in here.
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