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Configure additional form setting

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.

Before the SDV process is initiated based on the sponsors requirements, a percentage plan is created that specifies what CRFs must undergo SDV. One such simple percentage plan is the global SDV, which is developed to outline how much of the CRF data must undergo verification.

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.

In this section, you can learn how to configure SDV percentage settings for specific CRFs and their variables additional to the global SDV setting.

To configure additional form setting

  1. In the EDC application header, select the STUDY INFO tab.

  2. In the left pane of the page that opens, expand SDV and select the SDV Setting tab.

  3. On the SDV Setting - Global SDV page that opens, from the toolbar of the Additional form setting table, select New Item add_new_icon.png.

    Selecting to add form
    Figure 1. Selecting to add form

  4. In the New dialog that appears, enter the details of the form as explained in the following table.

    Configuring additional form setting
    Figure 2. Configuring additional form setting

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Form Name*

    Select the name of the form from the dropdown list whose percentage will differ from the global SDV.

    Represents the name of the form whose percentage differs from the global SDV.

    Percent(%)*

    Enter the percentage of data that you want to undergo SDV within the selected CRF.

    Variable(s)*

    Select the variables of the form being added. SDV is only performed for the selected variables.

    SAVE

    Select save_button_red.png to save the settings.

    CANCEL

    Select cancel_button_white_blue.png to dismiss without making any changes.

Once saved, the additional SDV settings are configured for the selected form and its variables. You can now execute and generate updated SDV.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.