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Delete SDR setting 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 adding various SDR setting records, it may occur that some configurations are incorrect or have become irrelevant to the study due to new sponsor requirements. In this case, the needed SDR setting records can be deleted. Once removed, make sure to execute the SDR setting to apply the updated configuration to the corresponding visits and subjects.

To delete the SDR setting 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 Setting tab.

  3. At the SDR Setting page that opens, select one of the following tabs:

    • By Visit: to delete the SDR setting record for a certain visit.

    • By Subject: to delete the SDR setting record for a certain subject.

  4. In the table that appears, next to the needed SDR setting record, select Delete trash_can_icon.png.

    Deleting SDR setting record
    Figure 1. Deleting SDR setting record

  5. In the Delete Item confirmation dialog that appears, select delete_button.png to remove the SDR setting record from the list.

    Confirming SDR setting record deletion
    Figure 2. Confirming SDR setting record deletion

Once confirmed, the SDR setting record is 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.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.