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Add SDR result record

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.

Under the SDR Result tab, you can track the SDR status on the reviewed source documentation. If there are some documents pertaining to some subjects or visits that need to undergo SDR and they are not on the list, you can add them additionally.

To add an SDR result record

  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 Result tab.

  3. From the workspace toolbar of the SDR Result page that opens, select New Item add_new_icon.png.

    Adding new SDR result record
    Figure 1. Adding new SDR result record

  4. In the dialog that appears, fill in the form as explained in the following table.

    Configuring new SDR result record
    Figure 2. Configuring new SDR result record

    Tip

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

    Element

    Details

    Site Code*

    Select the code of the site with subjects for whom you want to track SDR.

    Subject ID*

    Select the ID of the subject whose visits you want to track for SDR completion.

    Visit Name

    Select the visits that you want to add for SDR tracking. The SDR result records are added for each visit separately.

    SAVE

    Select save_button_red.png to add the SDR result record.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes and close the dialog.

Once saved, the new SDR result record is added to the list so the source documents in corresponding visits need to undergo SDR.

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.