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Create training document entry

In CTMS, study-related training documents can be tracked to confirm that team members are trained on key topics such as protocol presentations, safety guidelines, and system instructions. To begin, a training document entry must be created in the system, after which you can monitor which roles (such as CRA, PI, and others) have completed the training and which ones have not.

Important

Note that creating a training document entry refers to logging its details in CTMS; the actual content—such as documents or presentations—is shared with personnel through channels outside CTMS.

To create the training document entry

  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, select Training > Training Matrix.

  3. On the page that opens, select the Training Documents tab.

  4. From the workspace toolbar, select New add_new_icon.png.

    Selecting to create training document
    Figure 3. Selecting to create training document

  5. In the dialog that opens, enter the document entry details as explained in the following table.

    Creating training document entry
    Figure 4. Creating training document entry

    Tip

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

    Element

    Details

    Document Name*

    Enter a unique name for the document entry.

    Document Version*

    Enter the version of the document to help track updates.

    Document Type*

    Select the category of training inherited from predefined types in LIBRARY > Reference data > Training Type.

    Document Date*

    Select the date when the training document was created or issued.

    Training Program*

    Select one or more options that link the document to a broader training program for contextual grouping and tracking category. These values are predefined in LIBRARY > Reference data > Training Program.

    Expiration Date

    Select the date when the document is no longer valid or requires renewal.

    SAVE

    Select save_button.png to create the document entry.

    CANCEL

    Select cancel_button_white_blue.png to dismiss the process without saving.

Once saved, the document entry is created. You can now proceed to track the personnel who have completed the training.

In this section:

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.

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.