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Edit 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 require updating due to new sponsor requirements. In this case, the needed SDR setting records can be edited. Once edited, make sure to execute the SDR setting to apply the modified configuration to the corresponding visits and subjects.

To edit an 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. On the SDR Setting page that opens, select one of the following tabs:

    • By Visit: to edit the number of subjects related to a certain visit that needs to undergo SDR.

    • By Subject: to edit the number of visits related to a certain subject that needs to undergo SDR.

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

    Selecting to edit SDR setting record
    Figure 1. Selecting to edit SDR setting record

  5. In the Edit dialog that appears, the first field is read-only as it shows the visit or subject name. You can only update the list of subjects or visits that need to undergo SDR.

    Editing SDR setting record
    Figure 2. Editing SDR setting record

  6. Select save_button_red.png to save the implemented changes.

Once saved, the SDR setting record is updated.

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.