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Add staff members to study

There are different staff members who make the study conduct possible, including principal investigators, clinical research coordinators, data managers, clinical research associates, and so on. A list of staff members who are working on the study or at sites can be viewed on a separate page. You can add new staff members to the study if needed.

Important

Staff members added to the master study are automatically copied to the substudy. You cannot add the staff members directly to substudies—they only use the staff list from the master study.

To add new staff members to a study

  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 New Item Add_personnel_New_item_icon.png. From the dropdown menu that appears, select any of the following options:

    • Add from Entity: to add staff from the list of existing staff members in the system.

    • Add from Admin: to add staff from the list of existing admins in the system.

    • Add: to create a user to add as staff from scratch.

    Selecting option to add staff
    Figure 4. Selecting option to add staff

  4. In the form that appears, enter the details as explained in the following table.

    Adding staff member to study
    Figure 5. Adding staff member to study

    Tip

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

    Element

    Details

    Search Users

    Enter the name of the person that you want to add as staff member; once the results appear, select the name. Otherwise, scroll the list and select the needed name.

    This field and list of existing users are not shown if you are adding site personnel by creating a new user from scratch.

    Personal Info

    First Name*

    Last Name*

    Email*

    System Account

    Mobile

    Enter the personal contact number of the staff member.

    Office

    Enter the official contact number of the staff member.

    Fax

    Enter the fax number of the staff member.

    Address

    Enter the mailing address of the staff member.

    City

    Enter the city where the staff member is located.

    Province/State

    Enter the province or state where the staff member is located.

    Country/Region

    Enter the country or region where the staff member is located.

    Staff Info

    Company/Committee Name

    Select the name of the company or committee for which the staff member works.

    Title*

    Enter the job title of the staff member.

    Role*

    Select the job role assigned to the staff member in the study, such as investigator, coordinator, and others.

    If you select the role that belongs to site personnel according to its configurations, this staff member automatically appears in the personnel list of the respective site.

    If the existing list of roles is insufficient, you can add custom roles for the study staff to suit your business needs.

    Actual Joining Date*

    Select the date when the staff member officially joined the study.

    Actual Leaving Date

    Select the date when the staff member left or is expected to leave the study.

    Core Team Member

    Select an option to specify whether the staff member is part of the study's core team: Yes or No.

    Safety Distribution

    Select the level of access for safety distribution emails for the staff member:

    • To Recipient (General): the staff member is entitled to receive emails with the safety data reports for all subjects of the sponsor's studies. This level of access is most suitable for investigators.

    • To Recipient (Current Site Only): the staff member is entitled to receive emails with the safety data reports for subjects of the site where they are operating. This level of access is most useful for CRCs, CRAs, and other roles not involved in cross-study activities.

    • No selection: the staff member is not entitled to receive emails with the safety data reports.

    Responsible Scope*

    Level

    Select the level at which the staff operates—if they are entitled to perform activities of the entire study, a specific country, or a certain site only. The options available here depend on the applicable level settings of the selected role.

    If you add a staff member of the site level and whose role belongs to site personnel , then the added staff member also appears in the respective personnel list of the respective site.

    Country/Region Name

    Select the country or region where the staff member is involved in the study conduct.

    This field is only available if the Country/Region or Site level is selected for the staff.

    Site Code

    Select the unique identifier of the site where the staff member is involved in the study conduct.

    This field is only available if the Site level is selected for the staff.

    Subdivision

    Select a specific section or unit within the site.

    This field is displayed only for the CRA or investigator roles.

    SAVE

    Select save_button.png to implement the changes.

    Back to List

    Select back_arrow_icon.png to go back to Staff List without saving your changes.

Once done, the staff member is added to the study.

See also
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.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

In Pharmacovigilance, all the data on adverse events and other occurrences related or suspected to be related to investigational products. In eClinical, it is mostly data collected from subjects during clinical trials; this data helps to evaluate product safety and efficacy.

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator