Add or Modify XML fields in an Application

XML fields are used in regulatory submissions to help define the structure and metadata of the submission.

In RIM Basics: Submissions, most XML fields are automatically populated in an application - which is then pushed to the submission via the Submission Wizard - based on the equivalent field in the relevant application relationship: Products, Active Substances, Inactive Ingredients, Therapeutic Indications, Clinical Studies, and Nonclinical Studies.

Add or Modify an XML Field

To add or modify an XML field:

1. Select the appropriate Application Relationship to which you want to add or modify an XML field.

   

2. Click into the XML field you want to modify.

   • Some XML fields are automatically populated from a corresponding field. In the above example, XML Product is populated from the Product field.
   • Others may be left blank when their parent object type is not applicable to that field, such as the XML Duration field in a Pharmacokinetic nonclinical study.
   • Still others may be left blank but require manual input, such as XML Product Dosage Form.

   

3. Enter the desired value.

   

4. After entering the value, click out of the field to save.

   

Add Changes to the Submission

After any modifications are made to the application, use the Submission Wizard to add those changes to the submission itself.

1. Select the Submission Wizard from the All Actions () menu.

   

2. Select the relationship type(s) to add to the submission.

3. Click Next.

   

4. Select the specific relationship(s).

   You can add the XML fields to the Submission Wizard view via the Actions ellipsis (<i class="fas fa-ellipsis" alt="Black Ellipsis Icon"></i>) > Edit Columns.
   

5. Click Next.

   

6. Click Finish to complete the wizard.