Opening a Submission | |||||
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Click the name of the required submission project.
You can use the categories in the navigation pane to access information related to the submission project.
Category Name Page Tabs Page Sub Tabs Description For More Information Submission project name Schedule Status - Shows regulatory details about the submission project. Project Management User's Guide: Schedule Status Tab Dashboard - Shows the dashboard for the submission project. Submission Dashboard Properties Properties - Shows project details about the submission project. Submission Properties Preferences - Lists the preferences specific to this project. Project Management User's Guide: Setting Project Preferences Lifecycle Lifecycle Lets you view the lifecycle states of the submission project. If you do not see the Promote action, then all tasks and any approval routes related to the Request must be completed. If you see 
, then a route must be completed to move the regulatory request to the next state.3DEXPERIENCE Basics: Lifecycle Page Tasks/Signatures Approvals History - Provides an audit trail for the submission project. 3DEXPERIENCE Basics: Viewing History for Content Regulatory Information Properties - Shows regulatory details about the submission project. Regulatory Information Properties Page Requests Requests Lists all regulatory requests made for this submission. Regulatory Requests List Related Requests Lists regulatory requests for specific items in the submission schedule.
Contexts - Lists the contexts valid for this submission. Regulatory Contexts List Products - Products being submitted for regulatory approval that are managed by this submission project. Products List for a Submission Countries - Lists the countries where market authorization is being pursued. Countries List Regulatory Guidelines - Lists the guidelines from the regulatory authority for submissions that use the related regulatory contexts. Regulatory Guidelines List Languages - Lists the languages supported by the regulatory authority. Languages List Indications - Lists the medical indications for use of the product covered by this submission project. Indications Page Classifications - Lists the classifications for the product governed by the submission project. Classifications for Market Registration Lifecycle Lifecycle Lets you view the lifecycle states of the submission project. If you do not see the Promote action, then all tasks and any approval routes related to the Request must be completed. If you see , then a route must be completed to move the regulatory request to the next state.3DEXPERIENCE Basics: Lifecycle Page Tasks/Signatures Approvals History - Provides an audit trail for the submission project. 3DEXPERIENCE Basics: Viewing History for Content Correspondences - Lists communications between your company and the regulatory authority and other involved parties. Correspondence List Related Submissions - Lists other submission projects related to the submission. Submissions Page People Members - Lists the persons, groups, and roles added to the project and shows their project level access. Project Management User's Guide: Listing Project Members Sharing - Lists the people who can access the submission. 3DEXPERIENCE Basics: Sharing Page Contacts - Lists the contacts from the regulatory authority and other involved parties. Contacts Page Reviewers - Lists the contacts from the regulatory authority and other involved parties, and the internal reviewers for the regulatory request. Reviewers List Schedule Schedule - Shows the schedule for the project, including: phases, milestones, gates and tasks. Schedule for a Submission Project Gantt Chart - Shows the Gantt chart for the submission project. Project Management User's Guide: Viewing Gantt Charts Regulatory Calendar - The phases and milestones for a regulatory calendar with estimated and actual dates. Timeline for a Regulatory Calendar Page Review Questions - The structure and details for interactive review phases, and the review question tasks defined for the submission project. Review Questions for the Regulatory Calendar Experiments Experiments Lists experiments associated with the submission project. Project Management User's Guide: Experiments Page Structure Shows the schedule for the project, including: phases, milestones, gates and tasks. Schedule for a Submission Project Gantt Chart Shows the Gantt chart for the submission project. Project Management User's Guide: Viewing Gantt Charts Snapshots Submission Snapshot Lists snapshots of the submission taken at key points of the submission project. Submission Snapshots Page Structure Shows the schedule for the project, including: phases, milestones, gates and tasks. Schedule for a Submission Project Gantt Chart Shows the Gantt chart for the submission project. Project Management User's Guide: Viewing Gantt Charts Dashboard - Shows the dashboard for the submission project. Submission Dashboard Bookmarks Local Folders - Lists folders for this specific submission project. Folder Lists for Submissions Leader Folders Only shows if this submission project follows a lead submission.
- Lists the folders in the lead submission project.
Folder Lists for Submissions Libraries Only shows if IP Classification is installed.
- Lists the available libraries that can contain documents associated with the submission project. Libraries Tab Product DHF Only shows if Project and DHF Management is installed.
- Shows the design history file (DHF) view of the submission project. Product DHF Tab Master Folders - Lists folders in the submission master record. Folder Lists for Submissions Collaboration Bookmarks URL - Lists bookmarks for the submission project. Project Management User's Guide: Listing Bookmarks Decisions Decisions Lists decisions associated with the submission project. Collaboration and Approvals User's Guide: Decisions Page Related Decisions Lists the related decisions associated with the submission project. Discussions - Lists discussions about the submission project. Collaboration and Approvals User's Guide: Discussions Page Meetings - Lists meetings related to the submission project. Collaboration and Approvals User's Guide: Meetings Page Issues & Risks Issues Lists issues related to the submission project. Collaboration and Approvals User's Guide: Issues Summary/Issues Category Risks Lists risks related to the submission project. Project Management User's Guide: Listing Risks Routes & Approvals Routes Shows the routes for the submission project. Collaboration and Approvals User's Guide: Routes Page and Routes Summary Page Approvals Shows the approvals for the submission project. Project Management User's Guide: Viewing Approval Requirements Governed Items - Shows associated objects that are managed by the submission project. Project Management User's Guide: Listing a Project's Governed Items Market Authorization Change - - Lists the market authorization changes for this submission project. A submission might have more than one authorization change if it has more than one regulatory context. Market Authorization Changes List Publishing eCopy Only appears if submission is configured for eCopy submissions.
- Shows the structure and publishing options for eCopy submission projects. eCopy Page Package Only appears if submission is not configured for eCopy submissions.
- Shows the structure and packaging options for submission projects. Package Page Process Steps - - Shows the process steps that must be completed to complete the submission project. Submission Process Steps