Study drug data population in a study case

Summary

Updates to data population in case form product tab in study cases (Enhancements 32817082, 38290389, 36877711, 30481629, and 37634347)

Description

When a study drug is selected in a study case, the data in specific fields are populated based on the selected study drug. Data population of the case form fields is enhanced:

• for a blinded study when broken and study drug is selected
• for a not blinded study added to the study case and study drug is selected
• when the study drug already selected is replaced with another study drug
• when a new study drug is added to the case using the Add study drug option
• study drugs are selected though EOSU lite, EOSU advanced

Fields that are enhanced:

• Drug authorization country—This field is populated based on the Country of Incidence.
• Market authorization holder, Authorization type, Authorization number, WHO Record ID
  • If study drug selected is associated with Study Configuration > Primary License (when configured in Console), then populate data based on the Primary License.
  • If study drug selected is not associated with Study Configuration > Primary License (when configured in Console), then populate data based on the Individual Product License (when configured in Console).
  • If study drug is selected but if Study Configuration > Primary License is not configured and Individual Product License is not configured, then pick the license with license country = DAC. If there are multiple licenses for same country, pick the first license for that country as displayed in the Study Configuration > Product > License drop-down (order of display is based on License Country, License Number, Trade Name). If no matching license, do not populate data.
  • For WHO Record ID, if the data is not configured at the license level in console, then populate the data from product level in console if configured.
• Product Indication—This field is populated from Console > Product > Primary Indication based on the study drug selected. If user updates study drug in case form, refresh the Primary Indication as per the study drug selected. User can add, modify or delete the indication in case form.

Note:

When a non-company study drug (like WHODrug) is selected or updated in Case Form > Products > Study Drug for a case with a not blinded study or unblinded study, then the Authorization Number, Drug Authorization country, Market Authorization Holder, Authorization type data are not populated, and it is cleared if it was already populated. WHO Record ID is populated from the corresponding WHODrug dictionary if using C3 format only.