16 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 filter options above the worksheet to subset the dashboard’s data to your preferred view. Among others, filter options allow you to filter by submission level, version, category and type, as well as 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.
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 you track the site and country status within a study level submission.
This sheet provides multiple filters that allow you to subset data to you preferred view. Filters include: Study Name, Study Status, Portfolio, Country, Site Status, Site Name, Submission Level, Submission, Submission Version, and Protocol Version, among others.
Submission and Approval Activities
The Submission and Approval Activities worksheet includes submission activities information (e.g., Received, Compiled Package, etc.) as well as the sites included in the submission. For instance, the worksheet shows the submission's metadata like status, type, and version ID and more. Site data includes the site name, site creation date, approval, status, etc.
Submission Package Details
This worksheet lists all the documents included in the associated submission package along with the document status. Use the filters above the worksheet to search for specific documents or filter for documents that are not yet completed.
