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Role management

A role is defined as the set of access permissions and characteristics provided to a certain group of users and based on which they can use the eClinical system.

In the ADMIN application, under the ROLE tab, you can find the complete list of all the roles created in the eClinical system, such as DM, CRC, PI, Sponsor, and so on. These roles can be assigned to the eClinical users to grant them certain system permissions and access according to their functional characteristics.

The general details of each role available in the Role management list are explained in the following table.

Role management in ADMIN
Figure 1. Role management in ADMIN

Element

Details

Code

Represents the code of the role displayed in the system UI when operated by the respective user. This value is composed upon the role creation out of the role category and subcode values. If there is no subcode, then the code is just the role category.

For instance, if the role category is "CRC" and the subcode is "Study_Name_01," the role code is displayed in the system as "CRC/Study_Name_01." This makes it more convenient to trace role activity in system reports and operation history logs.

Category

Represents the kind of role that the associated users have in the clinical trial or system management based on their functional characteristics, such as DM, CRC, PI, Administrator, Tester, and so on.

Description

Represents specific descriptive details about the user role.

Modified Time

Represents the exact date, time, and time zone indicator when the role was last modified.

Status

Represents whether the user role is active or inactive.

Blind

Represents whether the user role is blinded or unblinded.
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.

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 conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.

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.