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Visit status details

A visit refers to a scheduled appointment between a participant and the clinical trial staff. During a visit, the participant undergoes a series of tests and assessments, which may include physical exams, blood tests, questionnaires, and so on. The purpose of these assessments is to evaluate the participant's health status and track any changes that may occur during the course of the trial.

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

Viewing visit status details
Figure 1. Viewing visit status details

Column

Details

Site Code

Represents a code of the site where the visit must take place or has already taken place.

Subject ID

Represents an ID of a subject for whom the data has been collected during the indicated visit.

Visit Name

Represents the name of the visit that must take place or has already taken place.

Complete Status

Represents the current status of the visit depending on its completeness.

Open Manual Query

Indicates whether a query has been manually opened by users for a visit because of some pertaining issues.

Answer Manual Query

Indicates whether some users have responded to the opened queries for a visit.

Open System Query

Indicates whether a query has been automatically generated by the system for a visit because of some pertaining issues.

DM Review

Indicates whether anyone from the data management team has already reviewed the data collected during a corresponding visit.

CRA Review

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

Safety Review

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

SDV

Indicates whether the clinical monitor or a quality control team member has reviewed the data collected during a corresponding visit and whether it matches the data in source documents.

Softlock

Indicates whether the data collected during a corresponding visit is temporarily locked or restricted from further editing because some issues require further investigation or resolution.

Sign

Indicates whether the data collected during a corresponding visit has been signed by the investigator or the sponsor, indicating that they have reviewed and approved the entered data.
In this section:

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).