Project Template Lifecycle

The basic information associated with a project template is limited. Anyone with access to a project template can view its lifecycle. Objects that use the project template policy include Project Template, Design Project Template, Submission Template, CAPA Template, Corrective Action Template, Preventive Action Template, Regulatory Calendar Template, Business Initiative Template, Product Development Template, and Product Management Template.

A Regulatory Calendar Template defines the milestones and schedule for the submission process to a specific regulatory context (consists of a submission type, regulatory category, and regulatory authority). The calendar is defined by the regulatory authority, and implemented in the app as a regulatory calendar template. The template can be associated with a submission template, or added to specific submission projects.

The Project Template lifecycle includes these states:

This page discusses:

In Work

The template can be used to create a project object type.

For Project Template objects, as used in Project Management, the template can be used to create a project and is listed by default on the Project Templates page.

For Submission Templates, Regulatory Leads create submission projects based on the submission template. If the template needs to be revised, such as new regulatory guidelines have been received, Regulatory Administrators promotes the submission template to Inactive, and copy it to create a new submission template. The new guidelines are then attached to the new template.

A Regulatory Calendar Template cannot be modified in the In Work state. It can be added to any submission template or submission project that uses the same regulatory context. If a regulatory calendar template needs to be updated, such as when the regulatory authority changes the regulatory guidelines that define the schedule, Regulatory Administrators can promote the template to obsolete.

For a Business Initiative Template, Product Development Template, or Product Management Template, you must have the Leader access role to create a template.

Draft

The template cannot be used to create a project object type.

For Project Templates, as used in Project Management, you can view the template by selecting the Draft filter on the template page.

Submission Template

For Submission Templates, Regulatory Administrators create submission templates in the Draft state. This allows the Regulatory Administrator to configure the template prior to making it available for use.

To configure the template, the Regulatory Administrator:

  • Adds a regulatory context.
  • Adds at least one country.
  • Adds any languages used by the regulatory authorities (regulatory authorities are part of the regulatory context).
  • Attaches the regulatory guideline specific to the this template.
  • Defines controlled bookmarks to prepare the dossier for submitting task deliverables to the regulatory authority.
  • Defines phases, tasks, and milestones in the Schedule page tab (sometimes called the Work Breakdown Structure or WBS) and choose the Volume (controlled bookmark) to contain that task's deliverables.

After the submission template is approved, the Regulatory Administrator uses the Lifecycle page to demote it to the In Work state.

Regulatory Calendar Template

For a Regulatory Calendar Template, the Regulatory Administrator creates the template in the Draft state. You need to attach at least one regulatory context with optional regulatory activity category and subcategory.

The schedule (work breakdown structure) can be defined with as many Regulatory Phases as required. When created, the schedule includes a single regulatory calendar phase with two regulatory milestones, one for Clock Start and the other for Market Authorization. These two milestones define the beginning and end of the submission process from the perspective of the regulatory authority. The regulatory calendar phase begins when the regulatory authority receives the submission dossier (Clock Start), and ends when Market Authorization is granted. In between, you can add regulatory milestones for various activities defined by the regulatory authority, such as an interactive review phase.

If you attach multiple regulatory contexts, the regulatory activity category and subcategory combination must be unique.

You do not need to attach regulatory guidelines to the template. You can only add regulatory guidelines that are already associated with a regulatory context for this regulatory calendar template.

After all required items have been attached and the schedule defined, A Regulatory Administrator must approve the template, and then promote it to active.