Submit protocol deviation template
After you have created a protocol deviation template and added data (questions) to it, your template is ready for submission. Once you submit a protocol deviation template, you can then use it in the STUDY MANAGEMENT tab for assigning the template to a study, site, or subject.
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In the CTMS application header, select the LIBRARY tab.
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On the page that opens, from the left pane, select the Protocol Deviation Template subtab.
Figure 1. Accessing protocol deviation templates
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From the PD Template List table, locate the template that you want to submit. Then next to it, select Submit
.Important
This option is only visible if you have just created your template or have made any modifications to the template. The newly created template or the changed modifications in the template require resubmission of the template.
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In the Submit dialog that appears, in the Comment field, enter any details related to the template that you want to specify.
Figure 2. Submitting protocol deviation template
Tip
The information you provide in the Comment field may be useful, especially if, while creating the template, you specified that your template requires approval from designated personnel. So if required, then in this field, add any details that you want the assignee to know before they start reviewing your template.
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Select
to save your changes.
The protocol deviation template is submitted. Based on the specifications you have set for the template, if you seek approval on your template, then the system sends the template to the assignee for approval and sets the template phase as Auditing in the PD Template List table. If approved, then the template phase is set to Final.
Alternatively, if you do not seek approval on your protocol deviation template, then upon saving your changes, the template is submitted and its phase is set to Final in the PD Template List table.