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Edit general SDV setting record

Source Data Verification (SDV) involves the review and comparison of data recorded in the source documents such as laboratory results, medical history, adverse event records, and so on against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors.

For the General SDV type, after configuring various SDV setting records, some configurations may be incorrect or require updating due to new sponsor requirements. In this case, the needed SDV setting records can be edited.

Important

Once any setting is edited, make sure to execute the SDV setting to apply the modified configuration to the corresponding forms.

To edit a general SDV setting record

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

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

  3. On the SDV Setting - General SDV page that opens, select one of the following tabs:

    • By Form: to edit the percentage of data fields in the specific form that needs to undergo SDV.

    • By Visit: to edit the percentage of forms in certain visits that need to undergo SDV.

    • By Subject: to edit the percentage of form data collected for a certain subject that needs to undergo SDV.

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

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

  5. In the Edit dialog that appears, the first field is read-only as it represents the form, visit, or subject name. You can edit other fields depending on whether you are updating the SDV setting record by form, by visit, or by subject.

    Editing SDV setting record by form
    Figure 2. Editing SDV setting record by form

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

Once saved, the SDV setting record is updated. You can now execute the SDV setting to apply the modified configuration to the corresponding forms.

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).

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.

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.