Listedness assessment based on onset date for SUSARs

Summary

Listedness assessment based onset date for SUSARs (Enhancement 33313288 and 31830885)

Description

As per EU clinical trials directive, expectedness assessments for SUSARs are required to be performed using the version of IB/RSI approved for the study, at the time of occurrence (event onset date) of the suspected SAR.

The following changes have been made in the application based on customer feedback on datasheet configuration and EU clinical trial regulations:

Datasheet configuration changes:

• The revision number is now visible in the Datasheet Configuration screen and the ability to capture the revision name of the datasheet, enables business users to view user-friendly information when reviewing case event assessment data.
• The ability to create datasheet revisions is provided without needing to add preferred terms to the datasheet.
• The datasheet revisions dialog is revised to view the revision and its corresponding terms in separate tables for better readability.
• The header rows within the datasheet preferred terms are now frozen when the user scrolls through the terms (Enhancement 26281827).

Study configuration changes:

• For all company study products, an option is provided to fix a datasheet revision for which event assessment can be performed.

  Caution:

  Oracle recommends not to configure datasheet revisions for open labeled study products within blinded studies, as these products are treated as non-study products in the case form.
• A new dialog is invoked for company products that have active datasheets and users can select one datasheet revision for multiple tradenames associated with the product.

Case form changes:

• The Case Event Assessment screen is enhanced to display the revision name and allow you to hide or unhide the datasheet revision details along with License using expand and collapse button (Enh 31830885).
• Datasheet name is appears as link. On click of this link, the datasheet revision number, name, activation date, and event terms pertaining to the latest datasheet revision are displayed.
• Datasheet revision and Activation dates appears as a link. On click of these links, the datasheet revision number, name, activation date, and event terms pertaining to the datasheet revision that was used for assessment are displayed.
• The above mentioned user interface changes are made in the Local Labeling and Medical Review screens.
• Event assessment for clinical trial cases is done considering the datasheet revision configured in the study and the onset date of the event.
• Upgrade consideration—For the study cases that were created prior to upgrade, if the event assessment is required to be done based on specific datasheet revision, then the following are required:
  • The company products within study configuration must be configured with datasheet revision.
  • Business users must use the Re-calculate option in the Event Assessment screen to use appropriate datasheet revision instead of using latest datasheet revision.
• The existing logic of using the latest datasheet revision is used in the following scenario:
  • All products in study cases where the datasheet revisions are not configured.
  • All products in non-study cases and non-company study cases.
  • non-company products and non-study products within study cases where the datasheet revisions are configured.