20R3 Data Model Changes: Commercial

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Commercial data model. These data model updates are automatically included in all Commercial Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 20R3.

Added the following components to support new features:

• Added new Medical Inquiry Case Response Cover Letter document type
• Added new document field Related Case Request (related_case_request__v) to the Case Request object
• Added new document field Related Case Response (related_case_response__v) to the Case Response object
• Added new object Embedded Metadata (embedded_metadata__sys)
• Updated the following fields to be non-mandatory on all documents:

  • Content Creation Cost (content_creation_cost__v)
  • Content Creation Currency (content_creation_currency__v)
  • Global Content Type (global_content_type__v)
• Added new Related Portals Portal Widget object type
• Added new Related Portals Portal Widget Content object type
• Added a label for the description/about section to the Portal object

The following components have been added to PromoMats Vaults:

• Added the following new objects:
  • Center (center_ectd__v)
  • Dosage (dosage__v)
  • Indication (indication__v)
  • Product Indication Join (product_indication_join__v)
  • Promotional Material Document Type (promotional_material_document_type__v)
• Added the following new document types:
  • eCTD Submission Ready Documents (ectd_submission_ready_documents__v)
  • Correspondence Letter (correspondence_letter__v)
  • Submission Ready Compliance Package (submission_ready_compliance_package__v)
  • Post Marketing Compliance Package (post_marketing_compliance_package__v)
  • Pre Clearance Compliance Package (pre_clearance_compliance_package__v)
  • Submission Ready Copies (submission_ready_copies__v)
  • Clean Material (clean_material__v)
  • Clean Product Label (clean_product_label__v)
  • Annotated Material (annotated_material__v)
  • Annotated Label (annotated_label__v)
  • Annotated Reference (annotated_reference__v)
• Added the following new picklists:
  • Launch Material Type (launch_material_type__v)
  • Professional/Consumer (professional_consumer__v)
• Added field FDA Reviewer (fda_reviewer__v) to the Application object
  • Added the following new object records for the Center object
    • CBER – APLB Advertising and Promotional Labeling Branch, HFM-602, Food and Drug Administration Center for Biologics Evaluation and Research, Document Control Center 10903 New Hampshire Ave. WO71 – G112 Silver Spring MD 20993-0002 21 CFR 601.45
    • CDER – OPDP Office of Prescription Drug Promotion Food and Drug Administration 5901-B Ammendale Road Beltsville MD 20705-1266 506(c)(2)(B) of the FD&C Act, 21 CFR 314.550
• Added new rendition type Final Audio/Video (final_video_audio__v)
• Added the following new records for the Promotional Material Document Type object:
  • Request for Advisory Launch
  • Request for Advisory Non-launch
  • Presubmission Accelerated Launch
  • Presubmission Accelerated Non-launch
• Added the following new document fields to different document types within the eCTD Submission Ready Documents types:
  • Application (application__v)
  • Professional/Consumer (professional_consumer__v)
  • Submission Date (submission_date__v)
  • Secondary Brands Application (secondary_brands_application__v)
  • Promotional Material Document Type (promotional_material_document_type__v)
  • Launch Material Type (launch_material_type__v)
  • Center (center_ectd__v)
  • Dosage (dosage__v)
  • Indication (indication__v)
  • Include Linked References (include_linked_references__v)
• Added new notification Export Compliance Package
• Added new binder eCTD Compliance
• Added new document lifecycle Submission Ready Lifecycle (submission_ready_lifecycle__v)
• Added the following new roles:
  • eCTD Regulatory Reviewer (regulatory_reviewer__v)
  • Compliance Package Publisher (compliance_package_publisher__v)
• Added new system state type Health Authority Ready State
• Added the following new user actions:
  • Export Compliance Package
• Updated the following document fields to be shared:
  • Application (application__v)
  • Center (center_ectd__v)
  • Promotional Material Document Type (promotional_material_document_type__v)
  • Dosage (dosage__v)
  • Professional/Consumer (professional_consumer__v)
  • Launch Material Type (launch_material_type__v)
  • Indication (indication__v)
  • Responsible Official (pm_contact__v)

The following components have been added to MedComms Vaults:

• Added the following new object types on the Person object:
  • Associated Contact (associated_contact__v)
  • Colleague (colleague__v)
  • Centralized Email Address (centralized_email_address__v)
• Added new field Primary Case Contact (primary_case_contact__v) on the Person object*
• Added the following new fields on the Case Response object:
  • Case Response Recipient Join (case_response_recipient_join__v)
  • Reply To (reply_to__v)
• Added new join object Case Response Recipient Join (case_response_recipient_join__v) with the following fields:
  • Case Response (Parent Object)
  • Person (Parent Object)
  • User (Parent Object)
  • Recipient Type (recipient_type__v)
  • The case_response_recipient_join__v object has the following object types:
    • Associated Contact (associated_contact__v)
    • Colleague (colleague__v)
    • Case Contact (case_contact__v)
    • User (user__v)
• Added new picklist Recipient Type (recipient_type__v) with values CC (cc__v) and BCC (bcc__v)
• Added the following new fields on the Case Response Emails object:
  • Reply To (reply_to__v)
  • CC Recipients (cc_recipients__v)
  • BCC Recipients (bcc_recipients__v)

* Only for the Associated Contact object type