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Source data review (SDR)

Source Data Review (SDR) relates to the process of ensuring data accuracy and integrity within a clinical trial. SDR refers to a broad assessment and review of the source data beyond a simple verification process. It involves a comprehensive review of the collected subject data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the clinical research associate (CRA) or data manager (DM) examines the data for completeness, accuracy, and compliance with the established criteria. They analyze trends, perform data reconciliations, and identify any potential anomalies or issues that may require further investigation or data clarification.

In the EDC application, after the data entry is completed for all visits, the CRA or DM can start to perform SDR according to the configured settings. The options available to the designated users to conduct SDR are explained in detail in the following sections:

SDR options
Figure 1. SDR options

See also
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.