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Analyze history of PD template association for study, site, or subject

In CTMS, you can analyze the operation history of the protocol deviation (PD) template associated with a study, site, or subject. By reviewing this history, you can track changes, updates, version upgrades, and much more, ensuring transparency and traceability throughout the protocol deviation management process.

To analyze the history of the PD template association for study, site, or subject

  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. On the study page, in the left pane, expand Protocol Deviation and select Setting.

  3. On the page that opens, from the workspace toolbar, select Operation History history_icon.png.

    Accessing operation history of PD template
    Figure 3. Accessing operation history of PD template

  4. In the dialog that opens, analyze the changes made to PD templates.

    Analyzing operation history of PD templates
    Figure 4. Analyzing operation history of PD templates

Once you have analyzed the changes, select OK to return to the template setting.

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.