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Download SDR result file from export history

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 submitting SDR result records or adding new ones to the list if required, the entire SDR result report can be exported from EDC to your computer in an XLSX file. All the previously exported files are stored in the export history, so you can download any previous version of it if needed.

To download the SDR result file from the export history

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

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

  3. From the workspace toolbar of the SDR Result page that opens, select History history_icon.png.

    Accessing export history
    Figure 1. Accessing export history

  4. In the Export History dialog that appears, view the complete history of previously generated files and next to the one(s) you want to download, select Export download_icon.png.

    Downloading file from export history
    Figure 2. Downloading file from export history

Once downloaded and saved, the SDR result report is available on your computer. Select ok_button_red_white.png to close the dialog.

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.