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Study administration

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.

In ADMIN, when the necessary sponsors are added to the client's company, you can create studies for each sponsor. The basic study entities are created via the ADMIN interface according to clinical trial specifications defined by the sponsor. The more advanced study details are maintained in the CTMS application after the corresponding sponsor is granted access.

Sponsor studies in ADMIN
Figure 1. Sponsor studies in ADMIN

Tip

The study team in charge of the trial management is required to provide basic information about the study in the Study Designer application upon its creation. However, the association of the study with this eClinical application must be done beforehand.

There can be two types of study design in ADMIN:

  • Independent study design: the study is a single entity that follows predefined protocol requirements and is designed to achieve sponsor's objectives.

  • Hierarchical study design: there is a master study and its substudies. A master study is an overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework, and each substudy is an individual component of a master protocol with its specific objectives; substudy inherits the core structure and governance from the master one but has its own endpoints.

Locating independent, master, or sub study
Figure 2. Locating independent, master, or sub study

While working with study entities within the ADMIN hierarchy structure, you can perform the following actions:

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.

In a clinical trial, a document that describes the objectives, design, methodology, statistical considerations, and aspects related to the organization of a study.