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Submit/Unsubmit 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.

After the SDR setting records have been defined and any additional SDR result records have been added, you can start to perform the actual review of the source documentation which can occur offline or among the uploaded files.

Once the SDR process has been finished, you need to submit the SDR result records, meaning to mark the corresponding visits with the reviewed source documents as SDR completed. However, if the SDR completion status is set by mistake or additional review is required, you can unsubmit such a record.

To submit or unsubmit 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. In the SDR Result table that appears, proceed with one of the following:

    1. Select the checkboxes next to the SDR result records in the Available status that you want to submit. Then from the workspace toolbar, select Submit execute_icon.png.

      Submitting SDR result records
      Figure 1. Submitting SDR result records

    2. Select the checkboxes next to the SDR result records with the SDR Completed status for which you want to cancel their review status. Then from the workspace toolbar, select Unsubmit unsubmit_icon.png.

      Unsubmitting SDR result records
      Figure 2. Unsubmitting SDR result records

Once submitted or unsubmitted, the selected SDR result records are marked as SDR Completed or Available respectively. The SDR Completed status means that the source documents for the corresponding visits are reviewed. And the Available status means that the source documents require another SDR procedure.

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.