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Define SDV workload

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors.

Once you have selected the SDV type for your study and configured either global, general, or target SDV settings, the planning stage may be considered complete. The next stage of SDV implementation involves the measurement of the workload required for the SDV process itself. Once it is measured and the time required for the SDV process is thoroughly calculated, you can define the workload for each form. This means you need to specify the time needed to verify each CRF against the source documentation.

To define the SDV workload for a CRF

  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 Workload tab.

  3. In the SDV Workload table that appears, select checkboxes next to the forms for which you want to define the SDV workload.

  4. Then from the workspace toolbar, select Edit pencil_icon.png.

  5. In the Workload (min) field of the Edit panel that expands, enter the minutes required to complete the SDV process for each of the selected forms.

    Defining SDV workload
    Figure 1. Defining SDV workload

  6. Select save_button_red.png to apply the specified SDV workload.

Once saved, the SDV workload is defined for the selected CRFs.

In this section:

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

See also eCRF.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.