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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 in 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.

Before the SDV process is started, a plan is developed to outline what data fields or pages of the CRFs must undergo verification. The plan may specify a random sample of records or target specific data elements based on risk or importance. With the SDV Setting functionality, CRAs can define what forms need to go through SDV and what percentage of data in those forms needs to be verified.

SDV Setting tab
Figure 1. SDV Setting tab

The actions you can perform under the SDV Setting tab are discussed in the following sections:

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.