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HDGabor

06/19/18 12:15 PM

#130772 RE: ziploc_1 #130768

z-

the vast majority of final patient visits have already been scrubbed

Agree, as all of the patients visits since 2nd IA have already been scrubbed also

and adjudicated

Agree, as adjudication is necessary only if an event detected "during" the visit (e.g. silent MI)

If final visits are stopped in June, these visits can be rapidly scrubbed and adjudicated

??? How do you mean it? As the vast majority of all data have already been scrubbed, any new data (input) could be scrubbed on the "next day"

Maybe I wasn't clear enough, so an example:

As of end of April, 97% of active patients done the visits, means that max. 245 were remaining (It was less, due to LtFu and death) and the data scrubbing is ongoing since "March 1" (first data input).

Based on the speed of the data input and scrubbing the "last" check is expected during the week July 2 (let's say by Friday, July 6). They could make the visits till July 4/5. Why not? To check the "245" data is less than a week.

I do not see any reason to stop the visits till the database could not be locked. If no visit by a patient … nothing to scrub.

Best,
G