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Create new version of protocol deviation template

When a protocol deviation template is assigned to a site, study, or subject, you cannot edit or inactivate it, as well as modify its data. Therefore, if for some reason you wish to change the data in the template that is assigned to a site, study, or subject, then you can create a new version of the template instead and modify it as required. However, note that the changes you perform to the new version do not affect the version of the template that is assigned to a site, study, or subject in the STUDY MANAGEMENT tab of CTMS.

After you create a new version, you can go to the STUDY MANAGEMENT tab and assign the latest version of the protocol deviation template to the needed site, study, or subject.

To create a new version of a protocol deviation template

  1. In the CTMS application header, select the LIBRARY tab.

  2. On the page that opens, from the left pane, select the Protocol Deviation Template subtab.

    Selecting Protocol Deviation Template subtab
    Figure 1. Selecting Protocol Deviation Template subtab

  3. From the PD Template List table, locate the template for which you want to create a new version, and next to it from the Actions column, select New Version copy_icon.png.

    Important

    This option is only available if the template is in use in the CTMS application.

  4. In the New Version dialog that appears, add the details as explained in the following table.

    Creating new version of protocol version template
    Figure 2. Creating new version of protocol version template

    Tip

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

    Element

    Details

    Need Approve

    Turn the toggle on if you want designated personnel to review and approve the new version of the protocol deviation template before you can start using it for a study, subject, or site in the STUDY MANAGEMENT tab of CTMS.

    Approve By*

    If you have turned the Need Approve toggle on, then in this dropdown, select the person(s) to whom you want to assign the new version of the protocol deviation template for review and approval.

    Description

    Represents a brief description of the purpose of creating the new version of the protocol deviation template.

    SAVE

    Select save_button.png to save your changes.

    CANCEL

    Select cancel_button_white_blue.png to discard your changes and return to the Protocol Deviation Template page.

Upon saving, the latest version of the template is created and it appears in the PD Template List table. You can modify it as required, and submit it to start using it in the STUDY MANAGEMENT tab.

In this section:

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.