Managing the Submission Dossier

You can specify a folder structure for a submission template that defines a dossier of documents to accompany submission projects based on that template, and create folders for individual submission projects.

A dossier is a hierarchy of controlled folders which are a type of workspace folder. The controlled folders are used as volumes to contain the deliverables for the submission project. To view the dossier, view the Folders page for the submission project.

Required access roles:

  • Specify a folder structure for a submission template: Regulatory Administrator
  • Create folders for individual submission projects: Regulatory Lead
  • Assign a task deliverable to a volume: Regulatory Lead
  • Synchronize a dossier: Regulatory Lead

See the Project Management User's Guide for details on using other actions on the Folders page.

This task shows you how to:

Before you begin: Open the required submission template or a submission project.

Creating a Controlled Folder

You can create controlled folders for a submission template and controlled folders for a submission project.

  1. In the navigation pane, click Folders.
  2. If you want to create a subfolder, select the parent folder. If you do not select anything, the new controlled folder is added at the top level of the hierarchy.
  3. From the page Actions menu or toolbar, click Folder Action > Create Folder.
  4. Enter these details:

    Field NameDescription
    TypeChange the type to Controlled Folder:

    1. Click . The Select Type dialog box opens.

    2. Click + to expand the Workspace Folder node.

    3. Select Controlled Folder.

    4. Click Select.

    NameType a short name for the folder.
    PolicySelect the policy type if it is not already set: Controlled Folder. If your company defined a custom policy, select the needed policy from the list.
    DescriptionType a detailed description of the purpose of the folder.
    Default User AccessSelect an option to control who should have read access to the folder:

    Access TypeDescription
    Read Any user who has view access to the project, either through direct membership or through company visibility, will have read access to the folder. Read access to the folder means being able to view and download the content of the folder. If you choose Read as the default access and Inherited as the access type, all project members are added to the folder's access list and are given Read access.
    Read Write Allows project members Read and Write access. Read access to the folder means being able to view and download the content of the folder. Write access to the folder means being able to change the content of the folder.
    Add Allows project members to add content to a folder.
    Remove Allows project members to remove content from a folder.
    Add Remove Allows project members Add and Remove access. Add access to the folder means being able to add content to the folder. Remove access to the folder means being able to remove the content from the folder.

    Inherit AccessSelect an access inheritance option from the drop-down list:

    OptionDescription
    YesFor subfolders, the subfolder's access list will inherit the parent folder's access list. Whenever the parent's access list is changed, the same change is made to the subfolder's access list. The subfolders's access list can be changed directly without affecting the parent's list.

    For top level folders, Inherited only applies when the Default Access is Read. In this case, all project members are added to the folder's access list and are given Read access.

    NoThe folder/subfolder's access list is not inherited from the parent. Changes to the parent or subfolder's access list are independent and have no affect on the other folder.

  5. Click Done.

The submission project can use the controlled folder as a volume for task deliverables.

Assigning a Task Deliverable to a Volume

You can associate a task, and its deliverable, with a volume. You can assign the volume for a task in a submission project that is not in the Complete, Archive, or Cancel states.

The volumes available for a submission project consist of the controlled folders created for the submission template (if the submission project is based on a template) and any controlled folders created for the specific submission project.

Before you begin: The tasks for the submission project should already be created.
  1. View the Schedule page for a submission project. See Schedule for a Submission Project.
  2. Click Enable Edit on the page toolbar.
  3. Click in the Volume column for a task.
  4. Click .
    The list of available controlled folders opens.
  5. Select the controlled folder you want the deliverable for this task to be added to.
  6. Click Submit.
    The folder shows in the volume column.
  7. Click Save.

The task deliverable is assigned to the selected volume.

Synchronizing the Submission Dossier

You can synchronize a dossier to the most recent revisions of documents added as deliverables for a task. You can only use this tool with tasks that have an assigned volume (controlled folder).

When the Regulatory User completes a task, Market Registration automatically syncs the dossier.

  1. View the Schedule page tab for the submission project. See Schedule for a Submission Project.
  2. Select the tasks you want to synchronize. You can only synchronize tasks that have been assigned to a controlled folder.
  3. From the Actions menu or toolbar, click Sync Submission Dossier.
  4. Click OK.

The documents in the dossier are updated to the latest revision.