Skip to main content

Site list

Site List is the page of EDC where you can view the list of sites from which subject data is collected.

Viewing sites involved in data collection
Figure 1. Viewing sites involved in data collection

Important

To view and access sites on this page, you need to have the respective access rights given by the system administrator via the ADMIN application. If you have access to only one site, you can only see that one. If you have access to three, you see only those three.

The process of granting permissions is the following: a site coordinator, sponsor, or other responsible person submits a request to grant the user access to a specific site. Once the user receives their username and password, they can access that particular site and start entering clinical data.

Each site you see on this page is initially created in CTMS (a unique site number is populated from there) and displayed as a separate tile.

Site information
Figure 2. Site information

At the top of the Site List page, you can find a toolbar with statistical information about the study for which clinical data is expected to be entered. The statuses you see here—Expected, Actual, In Screening, and so on—are manageable. You can either edit any status to customize it to your study needs or activate and inactivate the statuses to show and hide them from this toolbar.

You can find more details on the default toolbar statuses and other data in the following table.

Site statistics
Figure 3. Site statistics

Element

Details

Expected

Represents the number of subjects expected in a trial.

Actual

Represents the actual number of subjects currently enrolled in a trial.

In Screening

Represents the number of subjects currently undergoing screening.

Ongoing

Represents the number of subjects who have ongoing assessments of their health status.

Screening Failure

Represents the number of subjects who are not participating in the study for some reason.

Completed

Represents the number of subjects who have completed all the needed study activities and who can now be included in the pool of cases whereby the clinical efficacy and safety of the study drug can be evaluated.

Discontinued

Represents the number of subjects who are prematurely discontinued in the study for some reason.

Inactive

Represents the number of subjects who are deactivated in the study. For example, a subject can be deactivated if they do not meet the study inclusion criteria or refuse to participate in the clinical trial, or else.

My Open Manual Queries

A number next to My Open Manual Queries My_Open_Manual_Query_icon.png indicates the number of queries manually created by an investigator or monitor when they found inaccurate or missing data. These queries have to be addressed by you.

My Answered Manual Queries

A number next to My Answered Manual Queries my_answered_manul_query_icon.png indicates the number of manual queries addressed by you.

My Open System Queries

A number next to My Open System Queries my_open_system_query_icon.png indicates the number of queries automatically generated by the system when the data entered falls outside the predefined values. These queries have to be addressed by you.

My Answered System Queries

A number next to My Answered System Queries my_answered_system_query_icon.png indicates the number of system queries you have already addressed.
In this section:

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

A participant who is enrolled in a clinical trial and assigned to the site.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

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