19 Submissions and Approval Status
Workbook synopsis
This workbook, intended for Oracle Site Activate customers, shows country and site submission and approval activities and status, as well as all documents associated with a submission package.
Dashboards and sheets
Submissions and Approvals Dashboard
The Submissions and Approvals dashboard provides an at-a-glance view of a study’s submissions and approvals so you can easily identify countries that are falling behind.
The dashboard’s top level trend graph shows baseline, planned, and actual dates for all initial submissions and final approvals in two separate graphs. You can shift focus to baseline, planned, and actual by clicking a trend line in the graph.
The lower section of the dashboard displays submission and approval data in a stacked bar graph. The graph shows the number of submissions not planned (open), past due, and completed by country. Click on any bar in the graph to drill down to that detailed data in the Study Submissions worksheet.
Use the options in the filter panel to subset the dashboard’s data to your preferred view. Among others, the filter panel includes options to filter by submission level, version, and category, as well as protocol and protocol version.
Submission and Approval Status
This worksheet shows the submission and approval activities for all submissions in a study and includes the most recent note and note replies related to the submission, if available. Hover over tool tips, in the Initial Submission and Final Approval columns, provide summary detail. When appropriate, the Submission Info column includes information related to study level (EU) submissions. For example, the Submission Info column includes validation, Part 1, or Part 2 package description as well as “Reporting” with a Yes or No value for the member state displayed in the Country column.
Click on submission dates on the Submissions and Approval Status worksheet, to see the sites associated with the country submission (if any) display in a table at the bottom of the worksheet.
The Submission and Approval Status worksheet also provides columns like "Reporting Member State," "Country Approved," "Country Info," "Ready for Submission," "Site approved," and "Site Info" that will help report users to track the site and country status within a study level submission.
This sheet provides multiple filters to allow users to drill to the preferred view. Filters are: Study Status, Portfolio, Study Name, Country, Site Status, Site Name, Submission Level, Submission, Submission Version, Protocol Version, Submission Version ID, Submission Type, Submission Category, and Submission Status.
Sites in Submission
The Sites in Submission worksheet allows report users to leverage standard reporting features, like filtering and report export, as preferred.
Submission Package Details
This worksheet lists all the documents included in the associated submission package along with the document status. Use the filters, to the right, to search for specific documents or filter for documents that are not yet completed.
Export Submission & Approval Status
This worksheet, which is intended for export, provides detailed submission and approval status information, including detailed notes related to the submission reason. The worksheet includes multiple filters that allow you to adjust content prior to download.
Export Submission Package Details
This worksheet, which is intended for export, provides detailed study submission package information. The worksheet provides multiple filters, in the panel to the right, that allow you to adjust content prior to download.
