Literature Intake Updates

Following is the list of Literature Intake Updates:

• A new option Exclude from Report Candidates has been added to Oracle Argus Safety Console > Business Configuration > License Configuration as shown below.
  • This checkbox is displayed to only an Oracle Argus Safety Japan user and when Japanese module is enabled.
  • By default, this field is unchecked.
  • This checkbox is enabled only when the Authorization Country is Japan.
  • This field value is printed in License Configuration print PDF.
  • Updates to this field value are audit-logged.
    
• When the product is populated in the case created through J Literature Intake module, it populates only one record in the Case Form Products tab for each Product in the matching Product Family. If there are multiple Japanese licenses for a product, then the correct license is picked up based on the following logic:
  • License Authorization Country = Japan
  • Withdrawn date is blank or >= current system date
  • Hide checkbox is not selected for that product license combination
  • Not in Tradename lookup/Not Autoscheduled checkbox is not selected
  • Exclude from Report Candidates checkbox is not selected
  • If multiple licenses exist matching this criteria, then the Earliest awarded date license is considered
  • If multiple licenses still exist matching this criteria, then the license with the lowest internal sequence number is considered.
• Following is the change in logic that is used to populate Japanese licenses on Event Assessment and PMDA tabs. There is no change in logic for other country licenses. Manually Added Products through Bookin or Case Form or Case Intake or Affiliate Event Acceptance:
  • If the user selects a Japanese license during product selection in Bookin / Case Form / Affiliate Event, then only that license is considered for Event Assessment and PMDA tabs irrespective of the value of Exclude from Report Candidates checkbox.
  • If the user selects a non-Japanese license during product selection in Bookin / Case Form / Affiliate Event, then only the Japanese licenses for which Exclude from Report Candidates checkbox is not selected is considered for populating Japanese licenses in Event Assessment and PMDA tabs.
• Products Added through Literature Intake:
  • Only the Japanese licenses for which Exclude from Report Candidates checkbox is not selected are considered for populating Japanese licenses in Event Assessment and PMDA tabs.
• Products Added through E2B Import:
  • Only the Japanese licenses for which Exclude from Report Candidates checkbox is not selected are considered for populating Japanese licenses in Event Assessment and PMDA tabs.
  • While identifying the product license to be used to populate the Products tab, only those Japanese licenses are used for which Exclude from Report Candidates checkbox is not selected.
  • This is applicable to all the E2B factory profile logic - ICH, FDA, EMEA and PMDA.
• PMDA Event Assessment section on PMDA General tab:
  • Only the Japanese licenses for which Exclude from Report Candidates checkbox is not selected are considered for populating Japanese licenses in Event Assessment and PMDA tabs.
• Manual Report Scheduling dialog > License # drop-down displays only those Japanese licenses which are available on Event Assessment tab.
• The following change has been made while populating product licenses data in Case Form > Analysis tab > PMDA > General as well as Comment sub-tabs.
  • Marketed or Investigational Japanese Device Licenses is not populated, as PMDA General and Comments tab is not relevant for Device Reporting to PMDA.
  • Existing customer case data where Marketed or Investigational Japanese Device Licenses are already populated in PMDA General and Comments tab, has also been removed.
  • Removal of Marketed or Investigational Japanese Device Licenses from PMDA tab for existing customer data is audit logged with the SYSTEM user.