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Add participating organization to study

A participating organization is a data management, healthcare, software, or another organization that cooperates with the sponsor to provide data or services for a study. In the CTMS app, you need to add all the participating organizations to your study one by one.

Tip

Before adding the participating organization to the study, ensure it exists in the Entity > Participating Organizations list.

To add a participating organization 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 page that opens, select Study Details > Participating Organizations.

    Accessing participating organizations of study
    Figure 3. Accessing participating organizations of study

  3. From the workspace toolbar of Participating Organizations List, select New Item add_new_icon.png.

    Selecting option to add participating organization
    Figure 4. Selecting option to add participating organization

  4. In the dialog that opens, enter the participating organization details as explained in the following table.

    Adding participating organization details
    Figure 5. Adding participating organization details

    Tip

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

    Element

    Details

    Name*

    Enter the name of the participating organization responsible for supporting clinical trial activities.

    Type*

    Select the category of the participating organization, such as Committee, Health Care Provider, and so on.

    Obligation

    Describe the responsibilities of the participating organization in the clinical trial, such as providing trial site facilities, ensuring regulatory compliance, conducting patient recruitment, and so on.

    Address

    Enter the address of the participating organization that can be used for mailing, billing, and other purposes.

    Phone

    Enter the contact phone number of the participating organization.

    SAVE

    Select save_button.png to implement the changes.

    CANCEL

    Select cancel_button_white_blue.png to discard the changes without saving.

Once saved, the participating organization is added to the study.

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.