Additional Considerations to Determine Listedness

Note the following additional considerations that apply to the determination of listedness for events or cases.

• For the re-assess option, the system does not re-assess case level listedness if the common profile configuration for Case Inclusion criteria for the ICH PSUR/CTPR report based on Listedness is set to Use case level listedness. However, the system does recalculate event level listedness based on a selected algorithm.
• If the above configuration is set to Use listedness of the primary event, the system recalculates case level listedness based on the selected algorithm.
• You must limit a listedness assessment to target products.
• If no datasheet is selected in the inclusion criteria and the re-assess option is based on the datasheets, the system uses the datasheet of all the licenses for the selected product and recalculates the listedness based on the most conservative approach.

• If multiple products are part of the PSUR or CTPR report configuration and these products are also available in a case, the system bases the listedness assessment on the most conservative approach for case level listedness. Consider the following example:

  • Product A and Product B are target products.
  • Both products are available in the case.
  • The case has a primary event of Pyrexia and an event of Fever.

  For Product A, Pyrexia is a listed event but for Product B, Pyrexia is an unlisted event. The case level listedness is marked as Unlisted.

  For event level listedness, the same rules apply when assessing the case for multiple licenses of a product having different datasheets.

• If listedness for a case or event is not listed, it is counted under unlisted. This represents the scenario where event assessment has not been done and is NULL or unknown.