This article describes the Oracle Health Sciences Analyze Regulatory Submissions and Approval Status workbook. We've included the following sections:
- Workbook synopsis
- Dashboards and sheets
This workbook, intended for Oracle Health Sciences 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
Regulatory Submission and Approval Status
This worksheet shows the submission and approval activities for all submissions in a study, and includes the most recent note related to the submission, if available. Hover over tooltips, in the Initial Submission and Final Approval columns, provide summary detail.
Click on submission dates on the Regulatory Submissions and Approval Status worksheet, the sites associated with the country submission (if any) display in a table at the bottom of the worksheet.
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.
Regulatory Submission Package Details
This worksheet lists all the documents included in the associated submission package along with the document status. Use the filters provided to search for specific documents, or to filter for documents that are not completed.
Export Regulatory 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. Analyze provides multiple filters that allow users to adjust content prior to download.
Export Regulatory Submission Package Details
This worksheet, which is intended for export, provides detailed study submission package information. Analyze provides multiple filters that allow users to adjust content prior to download.
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