Edit additional form settings for global SDV
Source Data Verification (SDV) relates to the process of ensuring data accuracy and integrity within a clinical trial by reviewing and comparing the data recorded in the source documents, such as laboratory results, medical history, adverse event records, and so on against the data captured in the case report forms (CRFs). Once the SDV process is completed, the responsible personnel can review the findings and approve SDV.
At times, you might want to configure additional percentage settings for certain CRF data to undergo verification. This might be needed as the requirements of the sponsors are different due to the specifics of certain sites, prioritization of sensitive data fields, regulatory standards, and so on. If specific SDV configurations are set for any CRFs, they can be reviewed and managed from the Additional form setting block. Once additional SDV percentage is configured for certain CRFs, these form data follow their settings, while all the remaining forms follow the global SDV percentage setting. If needed, you can change the previously configured settings, for instance, add more or remove the variables that should undergo SDV.
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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 Setting tab.
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On the SDV Setting - Global SDV page that opens, from the Additional form setting list, locate the form you want to update. Then, from the Action(s) column next to it, select Edit
.
Figure 1. Locating edit option
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In the Edit dialog that appears, edit the details as explained in the following table.
Figure 2. Editing additional SDV settings for form
Element
Details
Form Name
This is a read-only field that represents the name of the form.
Variable(s)
Select variables to add them to the list of required for SDV. Clear the selection for the variables that you want to exclude from SDV.
Percent(%)
Enter the portion of the variable(s) that are subjected to SDV, that differs from the global SDV. The higher the percentage, the more crucial its variable(s) are in SDV.
SAVE
Select
to save the implemented changes. CANCEL
Select
to dismiss without making any changes.
Upon saving, the additional SDV percentage settings are changed for the CRF and its variables.