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Execute general SDV setting

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 the corresponding SDV setting records to implement the amount of CRF data that needs to undergo SDV according to the sponsor requirement, you need to execute the entire SDV setting to apply the configuration. Once it is applied, SDV approval becomes required for the corresponding amount of forms when conducting the data entry.

Example of CRF requiring SDV approval
Figure 1. Example of CRF requiring SDV approval

To execute a general SDV setting

  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. From the workspace toolbar of the SDV Setting - General SDV page that opens, select Execute execute_icon.png.

    Executing SDV setting
    Figure 2. Executing SDV setting

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

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.