Add subject tier assignment manually
Target source data verification (TSDV) is a more complex and sophisticated type of SDV setting as it provides an opportunity to perform more selective configurations compared to global or general types.
The TSDV setting includes the configuration of the TSDV plans that consist of various blocks and tiers to facilitate subject allocation based on certain criteria and design a selective TSDV procedure for various CRFs.
Once your TSDV plans are activated, you can review the result of subject allocation between different tiers of your plans. However, if you find that assignment results for a specific subject are missing from the table but you want them to be in the TSDV process, you can add them manually.
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In the EDC application header, select the STUDY INFO tab.
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In the left pane of the page that opens, expand SDV and select the SDV Result tab.
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On the page that opens, select the Subject Tier Assignment tab and from the workspace toolbar, select New Item
.
Figure 1. Adding subject tier assignment
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In the New dialog that appears, configure the subject assignment details as explained in the following table.
Figure 2. Configuring subject tier assignment
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Site Code*
Select the code of the site to which belongs the subject that you want to manually assign to a tier.
Subject ID*
Select the ID of the subject that you want to manually assign to a tier.
Tier Name*
Select the name of the tier to which you want to manually assign the subject.
Allocation Reason*
Enter the reason for the manual subject assignment.
SAVE
Select
to save the implemented changes.CANCEL
Select
to discard the changes without saving.
Once saved, the subject is assigned to the selected tier and you can track the results of this operation from the Subject Tier Assignment page.