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Visit windows in data entry

In a clinical trial, a visit window defines the allowable time span for a subject visit in case it is impossible to conduct that visit on the exact scheduled visit date.

The practice of visit windowing helps a data manager (DM) and the whole study team to correct the mistakes that might have occurred while entering the visit information for the site and configuring the study.

Another business case when visit windowing is proper is when the missed or out-of-window visits must be determined.

DMs define visit windows using different anchors assigned to the visits in the Study Designer (SD) app.

Tip

In eClinical, the anchor is a type of marker for a visit that is designated when a specific visit is expected. With a corresponding SD functionality, depending on the anchor assigned to the visit, the visit window with the prescribed activities is calculated.

Specified anchors for visit windows in SD
Figure 1. Specified anchors for visit windows in SD

For example, considering the preceding figure, if the Initial anchor is assigned to the Screening visit, the visit is expected to be the first one (considering the Target, Access, and Overdue settings).

Then if the Screening anchor is assigned to the C1D2 visit, the visit happens after the Screening visit occurs, and so on.

Once the window settings are populated from SD, from the DATA ENTRY module of EDC, the clinical research coordinator (CRC), clinical research associate (CRA), and other site personnel can utilize it for operational aspects to enter and manage data of each visit. It also reminds the subject about the next visit occurrence in advance. Also, the experts may need to check the visit windows for mistakes and whether the visit windows are in the permitted window ranges.

In EDC, the visit window functionality is available from both the DATA ENTRY and STUDY INFO modules. In the DATA ENTRY module, the visit window feature provides operational details to site personnel about the visit-specific data. In contrast, the visit window feature in the STUDY INFO module provides administrative information to individuals about the planning and protocol-specific data.

Visit window functionality in DATA ENTRY
Figure 2. Visit window functionality in DATA ENTRY

Thus, the Visit Window functionality in EDC is a management tool to supervise the visits of subjects within the visit cycle and act accordingly.

See also
In this section:

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.

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

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

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

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.