Form 2253 Field Mapping

Default Mapping

Every field on the generated Form 2253 can be mapped to a field on the binder, on the binder’s component documents, or on an object record referenced by the binder.

The mapping varies between Vaults, but the default configuration for PromoMats is detailed below. Contact your Vault Admin for information specific to your Vault’s mapping.

Note: The standard object model allows indirect mapping for some fields. For example, because there is a relationship between the Application object and the Product object, when users select a Product, Vault can map fields on the Application object to the form. In the table below, the example would appear as Document > Product > Application > Application Type.

#	Form Label	Form Sub-Label	Vault Field
1	DATE SUBMITTED		Binder > Submission Date
3	NDA/ANDA/AADA OR BLA/PLA/PMA	Number:	Binder > Document > Product > Application > Application Number
3	NDA/ANDA/AADA OR BLA/PLA/PMA	Single product	Binder > Document > Product > Application > Application Type
4	PROPRIETARY NAME		Binder > Product > Product Name
5	ESTABLISHED NAME		Binder > Product > Generic Name
6	PACKAGE INSERT DATE	(Latest final printed labeling)	Binder > Package Insert Date
6	PACKAGE ID NO.	(Latest final printed labeling)	Binder > Package Insert ID
7	MANUFACTURER NAME		Binder > Document > Product > Application > Applicant > Name
8a	ADVERTISEMENT / PROMOTIONAL LABELING MATERIALS	Professional	Binder > Consumer or Professional
8a	ADVERTISEMENT / PROMOTIONAL LABELING MATERIALS	Consumer	Binder > Consumer or Professional
b	Material Type		Binder > Document > Material Type
c	Dissemination/Publication Date		Binder > Document > Planned Date of First Use
d	Material ID Code		Binder > Document > Document Number
e	Material Description		Binder > Document > Document Name
\–	Comments		Binder > Comments
9	APPLICANT’S RETURN ADDRESS	Address 1	Binder > Document > Product > Application > Applicant > Address 1
	APPLICANT’S RETURN ADDRESS	Address 2	Binder > Document > Product > Application > Applicant > Address 2
	APPLICANT’S RETURN ADDRESS	City	Binder > Document > Product > Application > Applicant > City
	APPLICANT’S RETURN ADDRESS	State/Province/Region	Binder > Document > Product > Application > Applicant > State/Province/Region
	APPLICANT’S RETURN ADDRESS	Country	Binder > Document > Product > Application > Applicant > Country
	APPLICANT’S RETURN ADDRESS	ZIP or Postal Code	Binder > Document > Product > Application > Applicant > ZIP or Postal Code
10.a.	RESPONSIBLE OFFICIAL’S	PHONE NO.	Binder > Contact > Telephone Number
10.b.	RESPONSIBLE OFFICIAL’S	FAX NO.	Binder > Contact > Fax Number
10.c.	RESPONSIBLE OFFICIAL’S	Email Address	Binder > Contact > Email Address
11	TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT		Binder > Contact > Name and Title of Responsible Official

Changing from Single to Multi-Product 2253

The default mapping above works with PromoMats in the V15 release, which now supports multi-product submissions. The 2253 Supplementary Sheet lists all products from the Secondary Brands field on the Compliance Package binder, and details each product’s Application Type and Application Number. This is only possible if there is a relationship between the Application object and the Product object.

This configuration differs from V14, where the default PromoMats configuration included Application Type and Application Number as document fields on the Compliance Package document type, with no relationship to the Product object.

Note: The Product (product__v) field must be multi-select for your Vault to support multi-product 2253 generation.You must make the standard Product field multi-select. Form 2253 generation will not work with a custom document field that points to the Product object.

Multi-Product 2253: New Objects and Fields

Enabling the feature Application/Contact Objects and Doc Fields for 2253 Multi-product submissions automatically turns on the 2253 Submission Applicant Object and Doc Fields feature setting (if not already enabled) and provisions the following configuration elements:

• Objects
  • Application
  • Applicant
  • Contact
• Fields on the Compliance Binder document type
  • Applicant (V14)
  • Application Type (V14)
  • Application Number (V14)
  • Contact (V15)
• Fields on the Product object
  • Application (V15)
  • Center (V15) – Inferred from Application object
  • Applicant (V15) – Inferred from Application object

Field Setup

To successfully configure your PromoMats Vault with the new default object model, you must:

1. Inactivate or delete the following document fields on the Compliance Package document type: Application Type and Application Number.
2. Edit the Applicant document field on the Compliance Package document type. Go to the Security Overrides tab, and set the Default Security field to Hidden.

Applicant Field Details

The standard V15 setup automatically infers Applicant through the selected Product: Binder > Document > Product > Application > Applicant.

This setup is not required for the Supplementary Sheet populate correctly. Only Application Type and Application Number must be directly or indirectly associated with Product. However, it is best practice to associate an Applicant record to each drug Application record, as this provides a more scalable object model.

Data Setup

If you are now using the best practice object model for PromoMats and utilizing the new Application object, you must ensure the necessary data is in your Vault.

• Applicant object: Enter the manufacturer information into Applicant object records. Ignore the Name and Title of Responsible Official, Telephone, Fax, and Email fields if you are utilizing the new Contact object for responsible official information.
• Contact object: Enter the details of each of your responsible officials into Contact object records.
• Application object: Enter the Name, Application Type, Application Number, Center, and Applicant into Application records.
• Product object: Every 2253 applicable Product record must have an Application record associated with it. This allows Vault to pull the Application Type and Application Number into the 2253 Supplementary Sheet.

Form 2253 and Supplementary Sheet Remapping

After finalizing the object model changes and creating the necessary object records, contact Veeva Support or your Veeva Managed Services team to complete the field mapping. Completing the steps in this article first ensures that all of the setup is complete before Vault tries to use this data to generate 2253 forms.