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Import/Export protocol deviation template

In CTMS, you can import a protocol deviation template to the CTMS application or export a template from the application to your computer. You may require importing a template if you have a protocol deviation template that either perfectly or to some extent matches the study protocol requirements or the business needs so you simply want to import your template to the CTMS application and then modify it as required.

Similarly, for another study, you may require using a protocol deviation template that you already created for your existing study in the CTMS application. In such a scenario, you can export an existing protocol deviation template to your computer and then import it into the required study.

To import or export a protocol deviation template

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

  2. From the left pane, select the Protocol Deviation Template subtab.

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

  3. On the page that opens, perform any of the following actions, as required.

    1. From the workspace toolbar of the PD Template List table, select Import import_icon.png, and from your computer, select the required protocol deviation template in the CONFIG format to import.

    2. Select the required protocol deviation template, and from the workspace toolbar of the PD Template List table, select Export export_icon.png.

      Exporting protocol deviation template
      Figure 2. Exporting protocol deviation template

Based on your action, the protocol deviation template is imported to the CTMS application or exported from the application to your computer. The imported template file appears in the PD Template List table with the Draft phase until you submit the protocol deviation template, and an Inactive status until you submit it, and then change the status if required.

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.