Core RIM Data

RIM Admins are responsible for creating and managing your organization’s product families and other core data. Creating the core data in advance can make it quicker and easier for your team to plan, track, author, review, and approve submission documents. Submission managers use this core data to create applications, submissions, and content plans.

Managing Core Product Data

Product families are the foundation of your core product data. After creating a product family, you can begin creating and adding product data to the product family using the following data structure:

Some product data must be added to product data that you have already created, so ensure that you create your data in the right order. We recommend you create your data in the following order:

1. First, create your Product Family.
2. Second, create the following data for your product and product family:
   • Products
   • Active Substances
   • Inactive Ingredients
   • Therapeutic Indications
   • Clinical Studies
   • Nonclinical Studies
3. Third, create the following data for your product variants:
   • Product Manufacturers
   • Product Variants
   • Product Variant Active Substances
   • Product Variant Inactive Ingredients
4. Last, create the following remaining data:
   • Active Substance Manufacturers
   • Inactive Ingredient Manufacturers
   • Study Sites