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Define SDR workload

Source Data Review (SDR) refers to a comprehensive review of the collected data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the CRA or data management team examines the data for completeness, accuracy, and compliance with the study protocol and regulatory requirements.

After adding various SDR setting records and executing the configuration, the process of SDR planning can be considered complete. The next stage of SDR implementation involves the measurement of the workload required for the SDR process itself. Once it is measured and the time required for the SDR process is thoroughly calculated, you can define the workload for each visit. This means you need to specify the time needed to review source documents pertaining to different subjects under various visits. You can set different workload in minutes for different phases of a specific visit.

To define the SDR workload for a visit

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

  2. In the left pane of the page that opens, expand SDR and select the SDR Workload tab.

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

    Selecting visits
    Figure 1. Selecting visits

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

  5. On the Edit panel, fill in the attributes as explained in the following table.

    Defining SDR workload
    Figure 2. Defining SDR workload

    Element

    Details

    Applied Phase(s)

    Expand the dropdown list and select the study phase(s) during which the selected visit(s) are assigned the further configured workload.

    For instance, if the forms of the same visit vary for different study phases, the time spent on their SDR differs. Thus, you can set various workload values for the same visit but at different study phases.

    Workload (min)

    Enter the number of minutes to set as an estimated workload for the SDR procedure completion for the selected visit(s) during the selected phase(s).

    Workload Setting

    Select workload_setting_.png to add more fields of applied phases and workload.

    SAVE

    Select save_button_red.png to apply the specified SDR workload.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the workload editing without making any changes.

Once saved, the SDR workload is defined for the selected visits.

In this section:

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.

A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.

In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.