Configuring Constraints (RIM)

The Constraint object allows you to define constraints or filters for values used in object records. When data values or attributes have a hierarchical relationship to other categorical values, constraints can add control and ensure specificity of data at the time and point of entry.

Configuring Constraints

1. Navigate to Admin > Business Admin > Constraints.
2. Click Create.
3. When object types are configured, select a constraint type in the dialog and click Continue.
4. Complete the applicable fields.
5. Click Save.

Use Cases

Filtering the Application Type

In the Application object, you can filter the Application Type field based on the Region and Lead Market Country. This restricts the Application Type picklist to only display specific values (defined in the Controlled Vocabularies object) relevant to the previous selections of Region and Lead Market Country. To facilitate this, create a Constraint record and select the applicable Region, Country, and Application Type in the CV_1 field.

Filtering the Clinical Study Subtype

You can create a Constraint record to filter Clinical Study Subtype based on Clinical Study Type. In the Constraint record, select CV_1 as the Clinical Study Type, and select CV_2 as Clinical Study Subtype. The Region and Country fields are left blank in this example.

Mapping Global and Local Terms

Along with the related RIM application settings, you can create or update Constraint records which operate in tandem with Controlled Vocabulary records to allow users to select a preferred global term for Submission Type, Submission Subtype, and Manufacturing Site Role when creating records in bulk.

For Manufacturing Site Roles, Vault also uses these records during bundling or splitting, where the underlying Constraint records are referenced to populate a global value (defined on the Event relationship record) to the local Manufacturing Site Role term on the new Regulatory Objective relationship record.

To expedite this process, you can download a set of sample Constraint and Controlled Vocabulary records from the Vault Regulatory Updates page for the current General Release in the Veeva Product Support Portal.

Mapping Submission Type & Submission Subtype Terms

To allow users to select preferred global terms for the Submission Type and Submission Subtype when creating records in bulk:

1. Create two Controlled Vocabulary records and set the Controlled Vocabulary Type field to Global Submission Type and Global Submission Subtype, respectively.
2. Create two additional Controlled Vocabulary records with the Controlled Vocabulary Type field set to Submission Type and Submission Subtype, respectively. Your Vault may already have records of these types, which you can repurpose for this configuration.
3. Create a Constraint record and select Global to Local Submission Type as the Constraint Type. To map submission types, select the new Global Submission Type Controlled Vocabulary record (from Step 1) for CV_1, and the new Submission Type Controlled Vocabulary record for CV_2 (Step 2). To map submission subtypes, select the new Global Submission Subtype Controlled Vocabulary record (from Step 1) for CV_3, and the new Submission Subtype Controlled Vocabulary record for CV_4. Additionally, populate values for the Region, Country, and Constraint Scope for the application (Investigational, Marketing, Site Registration, or Substance).

These mapping records can replace any existing Planned Submission Constraint records in use in your Vault.

Mapping Manufacturing Site Role Terms

To populate the local Manufacturing Site Role term on records created in bulk, or via bundling and splitting, you must first configure the following:

1. Within each Event relationship object (for example, Event Product), ensure any Criteria VQL configured for the Manufacturing Site Role field only allows for global site role values.
2. Within each Application, Submission, Regulatory Objective, and Registration relationship object (for example, Application Active Substance and Registered Indication), ensure any Criteria VQL configured for the Manufacturing Role field only allows for local site role values.
3. Review your Vault’s Application object types and their corresponding Constraint Scope picklist values. For each Application object type (for example, Investigational Application), ensure the object type is represented in the list, and that the configured Picklist Value Name matches the object type name (investigational_application__c).

Then, create Controlled Vocabulary and Constraint records such that each global value for each market has one and only one corresponding local value:

1. Create a Controlled Vocabulary record and select Global Site Role as the Controlled Vocabulary Type.
2. Create a second Controlled Vocabulary record and set the Controlled Vocabulary Type field to Local Manufacturing Site Role.
3. Create a Constraint record and select Site Role as the Constraint Type. To map site roles, select the new Global Site Role Controlled Vocabulary record (from Step 1) for CV_1, and the new Local Manufacturing Site Role Controlled Vocabulary record (from Step 2) for CV_2. Additionally, populate values for the Region, Country, and Constraint Scope for the application (Investigational, Marketing, Site Registration, or Substance).

Using the Template Constraint Type Field

Using the Template Constraint Type picklist field, you can apply template constraints at an additional level defined by your organization, beyond the agency-driven values for Region, Country, Application Type, Submission Type, Submission Subtype, and Supplement Effective Date.

For example, a Submission Type of Variation Type IA in the European Union will require different sections to be included in the content plan, depending on whether it is for CMC, clinical, or labeling. To further constrain based on these values, you can add CMC, Clinical, and Labeling as Template Constraint Type picklist values, then create corresponding Application and Submission Constraint and Content Plan Template Constraint records with characteristics defined in the table below.

	Template Constraint Type	Constraint Option	Template Constraints
Constraint 1	CMC	Exclude	4 Nonclinical Study Reports and 5 Clinical Study Reports for eCTD Content Plan Template
Constraint 2	Clinical	Exclude	3 Quality and 4 Nonclinical Study Reports for eCTD Content Plan Template
Constraint 3	Labeling	Exclude	M2 Common Technical Document Summaries, 3 Quality, 4 Nonclinical Study Reports, and 5 Clinical Study Reports for eCTD Content Plan Template

Using the sample data, if you create a submission with a Template Constraint Type of Labeling and a new submission content plan using the eCTD Content Plan Template, a new submission content plan is created with only the 1 Administrative Information section, while sections 2 Common Technical Document Summaries through 5 Clinical Study Reports are excluded.

Supporting Certification Bodies in Multiple Markets

Though RIM Vaults support medical device applications in the European Union (EU) with the Organization Type picklist value Notified Body, your MedTech organization may need to support other markets with similar Health Authority-authorized certification bodies, such as the United Kingdom (Approved Body), Australia (Conformity Assessment Body), United States (Third Party Review Organization), and Japan (Registered Certification Body).

To do this, you can configure your Vault’s Constraint and supporting records as follows:

1. Relabel the Notified Body (notified_body__v) value within the Organization Type picklist to Certification Body.
2. Activate the Certification Body value within the Constraint Scope picklist.
3. Within the Constraint object:
   • Activate the Region Specific Entry standard object type (region_specific_entry__v)
   • Add all fields used in the custom Region Specific Entry object type (region_specific_entry__c) to the newly activated standard object type
   • Create an object page layout for the Region Specific Entry object type
4. Within the Application object:
   • Relabel the Notified Body (notified_body__v) field to Certification Body.
   • Add the following recommended help text: “A non-HA organization that has been designated, accredited, or authorized by the HA to assess submissions against local regulations. May be referred to as Notified Body, etc.”
   • Add criteria VQL to the Certification Body field such that Vault will display only Organizations from Constraints which meet the following criteria:
     • Organization has an Organization Type of notified_body__v
     • Constraint has a region_specific_entry__v object type
     • Constraint has an Applicable Product Type of Medical Device
     • Constraint has a Country which matches the Lead Market on the Registration
5. Within all Application object types, apply object page layout rules to display the Certification Body field when the Lead Market field is any country which uses a certification body, for example the EU.
6. Within the Registration object, add criteria VQL to the Certification Body (cerification_body__c) field such that Vault will display only Organizations from Constraints which meet the following criteria:
   • Organization has an Organization Type of notified_body__v
   • Constraint has a region_specific_entry__v object type
   • Constraint has an Applicable Product Type of Medical Device
   • Constraint has a Country which matches the Lead Market on the Registration
7. Add the Certification Body field to any applicable medical device Registration object types, including:
   • Investigational Device Registration
   • Marketed Device Registration
   • Manufacturing Site Registration

Once this preliminary configuration is complete:

1. Use Vault Loader to update existing Constraint records using the custom object type to use the new standard Region Specific Entry object type. Then, inactivate the custom Region Specific Entry object type.
2. Create new Constraint records of the Region Specific Entry type, selecting a Country and Organization, as well as the following:
   • Constraint Scope: Certification Body
   • Applicable Product Type: Medical Device

Constraint Types

Object types are automatically enabled on the Constraint object, including the default Application and Submission object type. You can configure additional custom object types, which will allow you to create new Constraint records and configure page layouts using specific object types.

For example, you can hide the Region, Country, CV_3, and CV_4 fields from a Constraint record that defines a Clinical Study Type – Clinical Study Subtype reference relationship. You can also set a dynamic reference constraint on CV_1 and CV_2 to filter Clinical Study Types and Clinical Study Subtypes, respectively, from Controlled Vocabularies.

By default, Vault sets all new records to the Application and Submission object type. You can choose to set custom-created Constraint object types as the default.

Updating the Object Type on Existing Constraints

You can use Vault Loader to assign the Application and Submission object type to existing Constraint records. This object type is used to populate the Constraint picklist when you extract from RIM Maintenance, and allows you to extract content plan templates based on constraints specific to Application and Submission and use filtering to create more contextual content plans.

You cannot update the object type for existing Constraint records in bulk. To update object types, you first must use Vault Loader to export existing constraints to a CSV file. Then, you can delete existing records in your Vault and load new records using the Create action.

Extract Existing Constraints

To extract existing constraints:

1. Navigate to the Loader tab.
2. In the left panel, click Extract.
3. From the Object Type drop-down, select Constraints.
4. Select the Override Default Column Selection checkbox and select columns to extract.
5. Click Extract. When Vault finishes processing the request, you’ll receive a Vault notification and email with request details and a CSV file.

Column Selection

To help identify which constraints need to be updated, we recommend adding the following columns to include in the extract:

• status__v (required)
• region__regulatory (required)
• region__regulatory.name__v
• country__rim (required)
• country__regulatory.name__v
• object_type__v (required)
• object_type__v.name__v
• cv_1__rim (required)
• cv_1__regulatory.name__v
• cv_2__rim (required)
• cv_2__regulatory.name__v
• cv_3__rim (required)
• cv_3__regulatory.name__v
• cv_4__rim (required)
• cv_4__regulatory.name__v

Preparing the CSV Input File

In order to successfully assign existing constraints to the Application and Submission object type, you need to enter the correct object type ID in the object_type__v field. You can obtain the object type ID by clicking on each object type defined for the Constraint object. Additionally, you must delete specific columns to avoid errors when uploading your CSV input file.

To prepare the CSV input file:

1. Download and open the CSV file that you extracted.
2. Locate the region_regulatory.name__v, country__regulatory.name__v, and object_type__v columns.
3. For any record identifying a constraint for the Application Type, Submission Type, Submission Subtype, and Supplemental Effective Date Type (usually this will be a record without a blank region_regulatory.name__v or country__regulatory.name__v column, but not always) enter the ID for the Application and Submission object type in the corresponding object_type__v column.
4. Delete the columns listed below. If any of these columns remain in your CSV file, the Create action will fail when loading your file.
5. Save the CSV file.

Columns to Delete

You must delete the following columns from your CSV file in order for Vault to create Constraint records correctly:

• id
• name__v
• region__regulatory.name__v
• country__regulatory.name__v
• object_type__v.name__v
• cv_1__regulatory.name__v
• cv_2__regulatory.name__v
• cv_3__regulatory.name__v
• cv_4__regulatory.name__v

Delete Existing Constraints

Because you cannot update the object type for existing Constraint records in bulk, you must bulk delete all existing Constraint records before uploading your CSV file.

Creating New Constraints

After you delete existing records, you can use your CSV input file to create new Constraint records:

1. Navigate to the Loader tab.
2. In the left panel, click Load.
3. For the CSV File, click Choose and select the CSV input file.
4. In the Object Type drop-down, select Constraints.
5. In the Action Type drop-down, select Create.
6. Click Start Load. When finished, you’ll receive a Vault notification and email with request details and CSV output files.

Related Permissions

The following permissions control your ability to configure constraints:

Type	Permission Label	Controls
Security Profile	Application: RIM Maintenance	Ability to navigate to the RIM Maintenance tab.
Security Profile	Objects: Create, Delete	Ability to load Content Plan Template Constraints through the Load action on the RIM Maintenance tab.
Security Profile	Objects: Read	Ability to view Content Plan Template, Content Plan Item Template, Constraint, and Content Plan Template Constraints through the Extract action on the RIM Maintenance tab.