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Item status details

A CRF item refers to a specific field on the CRF that requires a response or input from the participant or the investigator. CRF items are designed to gather specific and relevant information related to the study objectives and endpoints. The form items are usually developed based on the protocol of the study.

Within the Item Status Details page, you can view the details of each CRF item pulled from the EDC system. These details include information about the most current status of each item. Each CRF item status and other item characteristics are explained in detail in the following table.

Viewing item status details
Figure 1. Viewing item status details

Column

Details

Site Code

Represents a code of the site where the data for a corresponding CRF item has been collected.

Subject ID

Represents an ID of a subject for whom the data has been collected for a corresponding CRF item.

Visit Name

Represents the name of the visit during which the data has been collected for a corresponding CRF item.

Form Name

Represents the name of the CRF form that is used for data collection purposes.

Record SN

Represents a sequence number of the field item on the CRF.

Question

Represents a question text for a corresponding CRF item.

Caption

Represents a label or title to group related questions together and to provide an overall structure for the CRF.

Variable

Represents a CDASH variable for which the data is collected in a corresponding CRF item field.

Current Value

Represents the data value that has been entered in EDC for a corresponding CRF item field.

Complete Status

Represents the current status of the CRF item depending on its completeness.

DM Review

Indicates whether anyone from the data management team has already reviewed the data collected for a corresponding CRF item.

Safety Review

Indicates whether the adverse events data collected in a corresponding CRF item has been reviewed by the safety team and whether any safety issues have been addressed and documented.

CRA Review

Indicates whether the clinical research associates have already reviewed the data collected for a corresponding CRF item and whether any queries or issues have been raised and documented for resolution.

SDV

Indicates whether a clinical monitor or a quality control team member has reviewed the data collected for a corresponding CRF item and whether it complies with source documents.
In this section:

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

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 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).