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Configure target 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.

Important

Configuration of the SDV procedure depends on the SDV setting type selected for your study—global, general, or target SDV. This section explains the configurations required if the Target SDV type is established for the study.

Target SDV (TSDV) is more complex and sophisticated in terms of configurations than global and general SDV. For TSDV, you can configure multiple plans including various tiers, exclusion or inclusion criteria, and more to outline the forms, subjects, and other data elements as qualified for SDV during your study.

In this section, you can learn how to configure and manage your TSDV setting using the following instructions:

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.