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View study sites and depots

A study refers to a research investigation designed to evaluate the safety, efficacy, and other relevant aspects of a medical intervention, such as a drug, device, or treatment. Studies are conducted by a sponsor to gather data and evidence to support regulatory approval and contribute to the scientific understanding of medical interventions and preventions for existing ailments.

The basic study entities are created via the ADMIN interface according to clinical trial specifications defined by the sponsor. The more advanced study details as well as the creation of sites and depots are maintained in the CTMS application after the corresponding sponsor is granted access. In the ADMIN application, you can view what sites and depots are associated with the study across different lifecycles. This information provides a comprehensive overview of the logistical and operational elements of the study, contributing to its effective coordination throughout the trial.

Tip

A site refers to a specific location, such as a hospital, clinic, or research center, where the clinical trial is conducted. Clinical sites serve as physical locations where investigators interact with study participants, collect data, and administer investigational treatments.

A depot refers to a facility or storage location designated for storing and distributing investigational products (for example, drugs or devices) used in the study. Depots facilitate the maintenance of proper storage conditions, handling logistics, and ensuring the delivery of investigational products to sites.

To view study sites and depots

  1. In the ADMIN application header, select the HIERARCHIES tab.

  2. On the page that opens, from the toolbar of the left pane, select the needed lifecycle.

    Selecting lifecycle
    Figure 1. Selecting lifecycle

  3. Then select either chip_site.png or chip_depot.png depending on what entities you want to view for the study.

    Important

    The Site/Depot option is unavailable in the explorer tree if the sponsor does not use the eClinical apps that have site and depot infrastructure, such as EDC, IWRS, CTMS, and so on, but uses only SD or PV, for instance.

  4. In the same left pane, drill down the needed company and sponsor to select the study for which you want to see the site/depot list.

    Viewing study sites
    Figure 2. Viewing study sites

The list of study sites or depots is displayed in the contents panel.

In this section:

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.

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.

An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.

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

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.

An eClinical application that provides instruments for the collection of AE data from clinical trials, post-marketing, and literature. It carries out centralized management and scientific data evaluation through analysis, reporting, signal detection, and other methods, building a comprehensive pharmacovigilance informatization management and data integration system. The module is fully integrated with the EDC system and third-party systems through Safety Gateway. Also, the module supports a global regulatory submission of ICSR through E2B R3 electronic transmission.

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