Update Site Details for Risk Based Monitoring

This option enables users to add or modify additional information about the study sites compared to what is captured through the eCRFs. The following information can be captured in this file: Country (if this is not available through ADSL/DM data), City, State/Province, Zip Code, Latitude, Longitude, Site Active Date, Monitor, Vendor, Site Category (sites can be grouped, e.g.: Novice, Experienced, and Veteran). All these columns are optional and need not be populated. If Country, Monitor, and Vendor information is provided, then Risk Based Monitoring will create results at Country, Monitor, and Vendor level. If the Site Active Date is provided, then risk indicators will be calculated concerning enrollment rates. If Site Category is provided, then Risk Based Monitoring analysis can be run only on specific site categories.

Note: Currently City, State/Province, Zip Code, Latitude, and Longitude information is not used by Risk Based Monitoring. These columns were added to the file because we plan to add maps in the future indicating where the sites are located.

Refer to Site Details for Risk Based Monitoring Report for more information.

Requirements

This process requires the Demographics (DM) domain data set and the SITEIDvariable.

Output/Results

Running this process generates and surfaces a Site Details data set. The Site Details data set for the included Nicardipine sample data is shown below.