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Managing roles for study staff

There are different staff members who make the study conduct possible, including the roles of principal investigators, clinical research coordinators, data managers, clinical research associates, and so on. A list of roles for staff members can be managed per study to better reflect its structure and business needs.

Add new role for study staff

There are different staff members who make the study conduct possible by playing their respective business roles. In CTMS, the common clinical trial roles are preconfigured for you in the system, including investigator (principal and sub), clinical research coordinator (CRC), and clinical research associate (CRA). The list of roles involved in the study can be expanded by adding new ones according to your needs, and then assigning them to your study staff members to better reflect your personnel hierarchy and functional responsibilities.

To add a new role for the study staff

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. From the left pane of the study page that opens, select Study Details > Staff.

    Accessing study staff
    Figure 3. Accessing study staff

  3. In the Staff List table, from the workspace toolbar, select Role Management Gear_icon_gray.png.

    Accessing role management
    Figure 4. Accessing role management

  4. On the Role Management page that opens, from the workspace toolbar, select New Item add_new_icon.png.

    Selecting option to add new role
    Figure 5. Selecting option to add new role

  5. In the New dialog that appears, enter the details as explained in the following table.

    Adding new staff role
    Figure 6. Adding new staff role

    Tip

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

    Element

    Details

    Role*

    Enter the name of the role you are adding.

    Applicable Level(s)*

    Select the level at which the role operates; this depends on the scope of responsibility of the personnel that belong to this role—if they are entitled to perform activities of the entire study, a specific country, or a certain site only.

    This setting of the role dictates the available levels of responsibility for the staff for whom this role is selected.

    Belongs to Site Personnel

    Select one of the following:

    • Yes: the role is intended for staff members working at a site directly. Thus, when such a role is selected for the staff member, this staff member automatically appears in the personnel list of the respective site.

      For instance, Site 001 is a hospital, and the nurses are the site personnel. Thus, the "Research Nurse" role that is intended for those nurses must be set as Yes here.

    • No: the role is intended for study staff members who are not site personnel but can be involved in some site-related activities. Thus, when such a role is selected for the staff member, this staff member is not directly associated with any site.

      For instance, Site 001, which is a hospital, is visited by the regulatory coordinator for monitoring, but this person is not part of the site personnel. Thus, the "Regulatory coordinator" role intended for this person must be set as No here.

    SAVE

    Select save_button.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes.

Once saved, the role is added to the list. You can now select this role when adding the staff members to the study.

Edit role details for study staff

There are different staff members who make the study conduct possible by playing their respective business roles, such as investigator (principal and sub), clinical research coordinator (CRC), clinical research associate (CRA), and so on. In CTMS, you can add custom business roles that you can then assign to your study staff members to better reflect your personnel hierarchy and functional responsibilities.

You can adjust the role details whenever needed to keep up with the changing requirements.

To edit role details for the study staff

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. From the left pane of the study page that opens, select Study Details > Staff.

    Accessing study staff
    Figure 3. Accessing study staff

  3. In the Staff List table, from the workspace toolbar, select Role Management Gear_icon_gray.png.

    Accessing role management
    Figure 4. Accessing role management

  4. On the Role Management page that opens, locate the custom role that you want to edit. Then from the Action(s) column next to it, select Edit pencil_icon_gray.png.

    Important

    You can only edit active custom roles added by users; preset roles or roles that are inactivated cannot be adjusted.

    Selecting option to edit role details
    Figure 5. Selecting option to edit role details

  5. In the Edit dialog that appears, adjust the details as needed. These details are the same as those explained in the table of the Add new role for study staff section.

    Tip

    The ID field is read-only as the identifier is assigned automatically by the system upon the role creation.

    Editing role details
    Figure 6. Editing role details

  6. Select save_button.png to implement the changes.

Once saved, the study staff role is edited.

Activate/Inactivate study staff role

There are different staff members who make the study conduct possible by playing their respective business roles, such as investigator (principal and sub), clinical research coordinator (CRC), clinical research associate (CRA), and so on. In CTMS, you can add custom business roles that you can then assign to your study staff members to better reflect your personnel hierarchy and functional responsibilities.

If some roles are temporarily irrelevant to your study, you can inactivate them to prevent them from appearing on the list of roles when adding the study staff members. This helps keep the list of roles concise and current at all times. If the role is reinstated, you can activate it to make it available for staff members again.

To activate or inactivate a study staff role

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. From the left pane of the study page that opens, select Study Details > Staff.

    Accessing study staff
    Figure 3. Accessing study staff

  3. In the Staff List table, from the workspace toolbar, select Role Management Gear_icon_gray.png.

    Accessing role management
    Figure 4. Accessing role management

  4. On the Role Management page that opens, locate the custom role that you want to activate or inactivate. Then from the Action(s) column next to it, select one of the following:

    Important

    You can only activate or inactivate custom roles added by users; preset roles are active by default and cannot be deactivated.

    Activating and inactivating study staff roles
    Figure 5. Activating and inactivating study staff roles

  5. In the Reason dialog that appears, enter the comment to justify the role activation or inactivation. Then select save_button.png to confirm your action.

    Providing reason for role inactivation
    Figure 6. Providing reason for role inactivation

Once confirmed, based on your performed action, the role is activated and available or inactivated and unavailable for selection when managing the study staff members.

Analyze operation history for study staff role management

A study staff role, such as principal investigator, clinical research coordinator, data manager, and so on, can be predefined or manually added to the study staff management feature of CTMS for better categorization of the study personnel and precise reflection of the business processes in the system.

In the course of a clinical trial, various modifications can be made to the list of staff roles, and it is needed to keep record of such changes for compliance and traceability reasons. The operation history provides an exhaustive, structured log of events, helping you trace what they were, who performed them, and when.

To analyze the operation history for the study staff role management

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. From the left pane of the study page that opens, select Study Details > Staff.

    Accessing study staff
    Figure 3. Accessing study staff

  3. In the Staff List table, from the workspace toolbar, select Role Management Gear_icon_gray.png.

    Accessing role management
    Figure 4. Accessing role management

  4. On the Role Management page that opens, from the workspace toolbar, select Operation History history_icon.png.

    Accessing operation history for role management
    Figure 5. Accessing operation history for role management

  5. In the Operation History dialog that opens, analyze the details of all the actions performed with the staff roles from their creation to date.

    Analyzing operation history for role management
    Figure 6. Analyzing operation history for role management

You have analyzed the operation history for the staff role list. You can now select OK to close the dialog and return to the Role Management page.

In this section:

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.

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 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 overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.