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.

   

   Figure 1. Selecting Protocol Deviation Template subtab
   
   

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

   Import protocol deviation template

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

   

   Figure 2. Importing protocol deviation template

   
   
   Export protocol deviation template

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

      

      Figure 3. Exporting protocol deviation template
      
      

   2. In the dialog that appears, select the data export option as needed:

      • Export current version as Config: to extract a CONFIG file with configurations of the currently effective template version and use this file to import and set up a template in another study.

      • Export current version as PDF: to extract a PDF file with the currently effective template version details.

      • Export all version as PDF: to extract a ZIP folder with the current and all the historical versions of the template, each as a separate PDF file.

      Figure 4. Selecting export option
      
      

   3. Select and in the downloads widget that appears, view your download progress. Select the widget to open the My Downloads dialog.

      Figure 5. Downloads widget for protocol deviation template
      
      

   4. In the My Downloads dialog that opens, you can find the following tabs:

      • Preparing: lists all the files whose export is in progress, and they are not yet ready for download. Wait until the needed file moves to the Download is Ready tab.

      • Download is Ready: lists the files whose export is complete, and they can be downloaded to your computer by selecting .

      Figure 6. Downloading extracted protocol deviation template data
      
      

Based on your action, the protocol deviation template is imported to CTMS or the selected version of data is exported 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.

Tip

The extracted file version is saved in the system and can be accessed from Export History .

Figure 7. Accessing PD template export history