Running this process for the
Nicardipine
study generates the tabbed
Results
window shown below. Refer to the
Update Study Risk Data Set
process description for more information. Output from the process is organized into sections. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
This data table contains site-level data that is merged into the data taken from the study database to define sets of risk indicators for analysis with the
Risk-Based Monitoring Report
. This table can be manually updated to include additional relevant information.
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: Click this button to save your risk threshold data set. You are prompted to specify a unique name for the data set. The saved data set is surfaced as a selection in the
Risk Threshold Data Set
drop-down menu the next time you open
Risk Based Monitoring
.
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: Click
to add additional
variables
to the data table. By default,
Total Queries
,
Overdue Queries
,
Query Response Time
,
CRF Entry Response Time
,
Missing Pages,
and
Computed Deviations
are pre-defined.
Note
: Added variables must be numeric. Each new variable added generates two additional risk indicators, one normalized by number of randomized subjects and the second by patient-weeks on study.
Note
: Any pre-defined variables that are not used should be ignored.
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: Click
to save the updated data set..
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: Click
to check the validity of the variables in the risk threshold data set. A static report is generated showing the results of the check:
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: Click
to delete the updated risk threshold data set.
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