You can create PVA Outlines to generate draft pharmacovigilance agreement (PVA) documents for a PV Agreement, allowing your users to produce standardized PVAs for different use cases without the additional time and effort associated with manual PVA drafting. PVA Outlines are composed of PVA Outline Clauses that define the clause wording and order in the overall outline. You can further define PVA Outline Subclauses within a PVA Outline Clause for added granularity, each with their own wording and order.
Each PVA Outline’s associated Word Formatted Output Template defines the structure and format of the PVA documents Vault generates when users run the Generate Draft PVA action on the associated PV Agreement, as well as which elements of the PVA Outline appear in the generated document.
Prerequisite
To use this feature, your Admin must enable Generate Draft Pharmacovigilance Agreement Documents.
Create a PVA Outline
To create a PVA Outline:
- Navigate to PVAs > PVA Outlines.
- Select Create.
- In the Create PVA Outline dialog, complete the applicable fields.
- Select Save.
After you save the PVA Outline, a PVA Outline Clauses section appears.
PVA Outline Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name | Enter a name. |
| Description | Enter a description. |
| PV Agreement | Select the PV Agreement to which this outline applies. Once complete, you must also set the PVA Outline field on the PV Agreement to link to this PVA Outline. |
| Scope | Vault populates this field with the PVA Scope value from the associated PV Agreement. |
| PV Agreement Type | Vault populates this field with the PV Agreement Type value from the associated PV Agreement. |
| Word Formatted Output Template | Select a Word Formatted Output Template. Vault uses this template to generate a Word document containing the PVA Outline Clauses and PVA Outline Subclauses defined in the PVA Outline. |
Add a PVA Outline Clause
To create a PVA Outline Clause:
- Navigate to the PVA Outline for which you want to define a clause and expand the PVA Outline Clauses section.
- Select Create.
- In the Create PVA Outline Clause dialog, complete the applicable fields.
- Select Save.
If applicable, you can navigate to the PVA Outline Clause to add PVA Outline Subclauses.
PVA Outline Clause Fields
The following fields may be available:
| Field | Description |
|---|---|
| Name | Enter a name for the PVA Outline Clause. |
| Order in Outline | Enter a number to define the order in which this clause appears in the overall PVA Outline and generated PVA documents. |
| Clause Title | Enter a clause title. Depending on your Admin's configuration, Vault may use this value to define the title of the clause in generated PVA documents. |
| Clause Wording | Enter the clause wording. Depending on your Admin's configuration, Vault may use this value to define the body text of the clause in generated PVA documents |
| Task Instructions | Enter any task instructions required to meet the obligation. |
| Obligation Category | Select a category. |
Add a PVA Outline Subclause
To create a PVA Outline Subclause:
- Navigate to the PVA Outline Clause for which you want to define a subclause and expand the PVA Outline Subclauses section.
- Select Create.
- In the Create PVA Outline Subclause dialog, complete the applicable fields.
- Select Save.
PVA Outline Subclause Fields
The following fields may be available:
| Field | Description |
|---|---|
| PVA Outline Clause | Vault populates this field with the parent PVA Outline Clause. |
| Order in Outline | Enter a number to define the order in which this subclause appears in the overall PVA Outline Clause and generated PVA documents. |
| Clause Title | Enter a clause title. Depending on your Admin's configuration, Vault may use this value to define the title of the subclause in generated PVA documents. |
| Clause Wording | Enter the subclause wording. Depending on your Admin's configuration, Vault may use this value to define the body text of the subclause in generated PVA documents. |
| Task Instructions | Enter any task instructions required to meet the obligation. |
| Obligation Category | Select a category. |