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Add new role

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, you can create new roles to introduce a new set of access permissions and characteristics per sponsor request or other reason.

To add a new role

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

  2. On the Role management page that appears, select New Item add_new_icon.png.

    Selecting option to add new role
    Figure 1. Selecting option to add new role

  3. In the New Role panel that expands, provide role details as explained in the following table.

    Adding new role details
    Figure 2. Adding new role details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Category*

    Select 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, Sponsor, Administrator, Tester, and so on.

    This value is automatically added to the Code value as a first part of the role name.

    SubCode

    Enter the application or specific study to which the role might have access.

    This value is automatically added to the Code value as a second part of the role name after the slash to provide some specification.

    Code*

    Represents the autofilled value that is the combination of the Category and SubCode field values, divided by a slash. This is needed to give a more specific name to the role for further distinguishing, since this code is displayed in the system UI when you manage roles, so you know what permissions to grant and what characteristics to give to the role; and it is also recorded in system reports and history when operated by the respective user.

    For instance, if you handle multiple studies with different PIs, you might want to give them different access permissions in the system; thus, you need to create different user roles to assign to them. In ADMIN, you can do it by selecting the PI category and entering the Study 1 subcode for one role, and then creating another one by selecting the PI category as well, but entering the Study 2 subcode. Thus, you will have two roles—PI/Study 1 and PI/Study 2.

    Description*

    Enter some descriptive details to elaborate on the role significance or specifications.

    Blind

    Set as follows:

    • Turn this toggle on to provide the role being added a blinded view, meaning that the sensitive data will be hidden from the user to ensure study integrity.

    • Turn the toggle off to unblind the user role, thus, providing them the ability to see and interact with sensitive study data.

    This field only appears if you have permission to manage blinding status for user roles granted from the ADMIN application.

    Active

    Set as follows:

    • Turn the toggle on if the role being added must be activated upon creation. The users of an active role obtain immediate access to the applications and studies.

    • Turn the toggle off if the role being added must be inactive upon creation. The users of an inactive role cannot access the applications and studies until activated.

    You can activate and inactive the role later on as needed.

    SAVE

    Select save_button_red_white.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving.

Once saved, the new role is added. You can now grant access permissions to this role and start using it while creating new users.

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.