Summary

This article covers the contents of the submission details report and how to export the report.

Table of Contents


The Submission Details report will show the status of regulatory submissions and provide an overview of the requirements for each submission.


When the Submission Details report is accessed the report displays the status for all submissions and amendments for a study that contain a Ready for Submission status on the Manage Submissions Screen. The Report can be filtered based on the following Data:

  • Study: To view the report for a particular study, select the study from the Study multi-dropdown selection.
  • Submission Status: To view the report for regulatory submissions and amendments with statuses of “Incomplete”, “Ready for Submission” and “Submitted”, select the status from the multi-dropdown selection.
  • Regulatory Body: To view the report based on specific regulatory bodies, select the body from the multi-dropdown selection.

Selecting the Submission Name will direct the user to Edit Submission page.
When the Details icon is selected the submission requirements will appear, displaying the set name, total number of requirements, number of requirements that have been marked ‘Completed’ and the number of requirements that have the incomplete status.


Exports

By clicking the options Excel, CSV, or PDF in the Actions menu, the system will provide an export of the Submission Details table, based on the filter/search criteria applied. The export will also contain an Export Summary table to provide details of the report, such as the user requesting the report, their role, the study chosen (if the Study column was filtered on specific studies), and the generation and start times of the report export.



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