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.

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.

Site Details for Risk Based Monitoring Report

This file can have the following data:

  • Geographic parameters of the sites:

    • Country

    • City

    • State / Province

    • Zip Code

    • Latitude

    • Longitude

  • Site Active Date - the date when the site became active. This is used to calculate risk indicators concerning enrollment rates

  • Site Category - sites can be grouped, e.g.: Novice, Experienced, and Veteran

  • Monitor - name or ID of the monitor

  • Vendor - name or ID of the vendor

Note: The Site Details data file is optional. The Risk Based Monitoring report can be run without it. However, certain options within this report are not available unless this data table is present. If users want to run analysis at Monitor or Vendor level and if they want risk indicators concerning enrollment rates, then this file needs to be set up.

Example

A Site Details data table for the Nicardipine example is included with JMP Clinical and it is called NicardipineRBM_en.jmp for English locale. If locale is Chinese, then the file is Nicardipine_zh.jmp and if it is Japanese, then the file is NicardipineRBM_zh.jmp. This file can be found in the Notes directory of the Nicardipine study, if Nicardipine is registered in JMP Clinical (C:\Users\username\Documents\JMPClinical19\Configurations\Default\Notes\Nicardipine on Windows and in /Users/username/Documents/JMPClinical19/Configurations/Default on Macs) or in the installation folder (C:\ProgramData\JMP\JMPClinical\19\Clinical\Sample Data\Nicardipine on Windows) .

Note especially the three highlighted columns; these correspond to options on the RBM report.

Generating the Study Risk Data Set

Users must generate the Site Details data table and enter site-specific descriptive information. This is done using the Update Site Details for Risk Based Monitoring action button on the Studies tab.