Upgrade version of PD template for study, site, or subject
A protocol deviation (PD) is any change, divergence, or departure from the study design and procedures originally approved and defined in the protocol, consent document, or other study materials.
To seamlessly record potential or occurred protocol deviations, the predefined template from the CTMS library is associated with a study, site, or subject to document the corresponding divergence from the protocol. If the template is later updated in the library, you may choose to upgrade your associated template to the latest available version.
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Access the study management page in one of the following ways:
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In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.
Figure 1. Accessing study management from dashboard
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In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.
Figure 2. Accessing study management from study data list
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On the study page, in the left pane, select Protocol Deviation > Setting.
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In the Template Setting block, next to the study, site, or subject's associated template, select Upgrade Version
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Note that this option is only visible for the templates that have an updated version available in the library.
Figure 3. Selecting to upgrade version
Tip
You can select the associated template link to go to the template in the CTMS library and update it if needed.
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In the dialog that opens, analyze the template version details, and to proceed with upgrading, select CONFIRM.
Figure 4. Upgrading template version
Once confirmed, the study, site, or subject becomes upgraded to the latest version of the associated protocol deviation template.