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Activate/Inactivate protocol deviation template

In CTMS, you can modify the status of a protocol deviation template. You can either set the template's status to Active or Inactive. An active protocol deviation template can be assigned to a site, study, or subject via the STUDY MANAGEMENT tab of CTMS. Whereas, an inactive template cannot be assigned to a site, study, or subject. You may want to inactivate a template if, for example, it is not currently required for the ongoing study but it might be used for another study, site, or subject in the future, so you cannot risk losing it. Therefore, in the future, whenever required, you can again re-activate it.

To activate or inactivate 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 active template that you want to inactivate or an inactive template that you want to activate.

  4. Next to the template, select Activate activate_icon.png or Inactivate inactivate_icon.png as required.

    Activating/Inactivating protocol deviation template
    Figure 2. Activating/Inactivating protocol deviation template

Once the needed actions are performed, the protocol deviation template is activated or inactivated.

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.