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SDR result

Source Data Review (SDR) refers to a comprehensive review of the collected data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the CRA or data management team examines the data for completeness, accuracy, and compliance with the study protocol and regulatory requirements.

After the needed SDR setting records have been added and the SDR workload has been defined for all visits, you can start to review source documents. Under the SDR Result tab, you can track the SDR status on the reviewed source documentation. If there are some documents pertaining to some subjects or visits that need to undergo SDR and they are not on the list, you can add them additionally.

SDR Result tab
Figure 1. SDR Result tab

Tip

In the SDR Availability column of the SDR Result grid, you can filter out all visits available for SDR. Once filtered, select the hyperlink in the Visit Name column to go to the folder with the source documentation for a corresponding visit where you can conduct SDR. The visit is not available for the SDR process if the visit itself or its subject is softlocked, disabled, or has the Initial status.

Moreover, from the workspace toolbar, you can select Go to Chart chart_icon.png to go to the SDV & SDR workload report where you learn about the overall time spent on the SDR completion and time required for the SDR completion for visits that have not yet undergone SDR.

Under the SDR Result tab, you can perform the following actions:

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.