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Execute SDR setting

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.

The SDR process is usually done offline by the CRA who needs to go to each study site to review source documents. All of the source documents can be uploaded to EDC in order to achieve data compliance. Once uploaded and you have specified for which visits and subjects the SDR must occur, you need to apply the SDR configuration. Once applied, SDR approval will become required for source documents of corresponding visits and subjects.

Source documents that require SDR approval
Figure 1. Source documents that require SDR approval

To execute an SDR setting

  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 Setting tab.

  3. From the workspace toolbar of the SDR Setting page that opens, select Execute execute_icon.png.

    Executing SDR setting
    Figure 2. Executing SDR setting

Once executed, the SDR setting becomes applied. You can now track the results of the conducted SDR process.

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.