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Delete 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 some of the previously added SDR result records are now irrelevant, you can delete them at any time to keep the result list up-to-date.

To delete the SDR result records

  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. In the SDR Result table that appears, select checkboxes next to the SDR result records that you want to remove.

  4. Then from the workspace toolbar, select Delete trash_can_icon.png.

    Selecting Delete option
    Figure 1. Selecting Delete option

  5. In the Delete Item confirmation dialog that appears, select delete_button.png to remove the selected SDR result records from the list.

    Deleting SDV result record
    Figure 2. Deleting SDV result record

Once confirmed, the selected SDR result records are deleted.

See also
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.