MedWatch 2022 updates

Summary

FDA MedWatch 3500A form version 11/22 updates (Enhancement 34764890)

Description

Food and Drug Authority (FDA) has released new MedWatch form in November 2022 for Manufacturers, User Facilities, and Importers to submit adverse events reported for Drugs or Devices to FDA.

Oracle Argus Safety is enhanced to support 2022 template released by FDA for the MedWatch Drug report using a new Interchange profile.

The following sections lists the changes made in the application to support the new MedWatch Drug report.

Case Form changes

• New field named Current Gender is added in Case Form > Patient.
• In the Patient tab, the existing Gender field is renamed as Gender at Birth.
• The values that are populated in the Current Gender and Gender at Birth fields are controlled through MEDWATCH attribute in the GENDER flexible code list.

Console changes

• CBER-IND is added to the Clinical Reference Type code list as factory data and IND reference type is renamed for CDER-IND. These values are used for the IND number population logic in box G4.
• New values are added to the Gender code list along with new attribute MEDWATCH to control the values to be displayed in the Current Gender and Gender at Birth fields.
• The length of the Gender code list is increased from 15 to 25.
• The following changes are made to the Reporting Destination code list:
  • When the agency configured with MedWatch profile has Email address as blank, after selecting the Preferred Method as Email, a warning message appears asking you to fill in the email address.
  • The Attachments field in the Agency Information > Report Transmissions options are set to the default value of Single. This setting ensures that the system generates individual PDF reports and attach them to emails.
  • In the Reporting Destination EDI tab, transmission related fields are disabled when the MedWatch profile is selected in EDI > Message profile for both standard and custom MedWatch.
• New MedWatch attribute is introduced in DOSE_FREQUENCY.

Note:

• The MedWatch Device report is not upgraded to 2022 format as it is not used for regulatory reporting purpose.
• Transmission of the MedWatch drug report using fax route is de-supported.
• The common profile switches present in the following location are not used for the MedWatch Drug report, but are used in the MedWatch Device report as per the existing functionality:
  • Reporting > Expedited > MedWatch
  • Reporting > Expedited > MedWatch > MedWatch Configuration

For more information, refer to the Argus_Safety_8.4.2_CaseForm_Console_Updates_Summary.xlsx.

Interchange mapping updates

The FDA MedWatch 3500A Drug Template for MedWatch is now supported through the Interchange Mapping Utility framework with default profile and out of the box mappings.

The system supports copy of the profile and allows editing of the copied profile.

For more information on the mappings, refer to the ArgusSafety8.4.2_MWPaperReportMappings.xlsx.

Generation, transmission, tracking of reports

• The MedWatch Drug report is scheduled through manual scheduling and auto scheduling, can be generated from the following locations:
  • Regulatory reports tab
  • Batch reports using Case actions > Open
  • Draft tool bar
  • ICH PSUR, CTPR, and NDA periodic reports
• The MedWatch Drug report is generated in PDF format and can be transmitted in the Email route.
• You can send and track MedWatch drug reports from Worklist > Bulk Transmit.
• The MedWatch Drug report form is used to invoke the MedWatch 2022 format and it can be invoked from the following locations as per the existing functionality:
  • Case Form > Regulatory Reports tab
  • Case Form > Draft tool bar
  • Case Form > Medical Review dialog
  • Worklist > Bulk transmits
  • Worklist > Reports
  • Reports > Compliance > Expedited
  • Reports > Compliance > Submitted
  • Reports > Bulk Reporting
  • Business Configuration > Expedited Reporting Rules > Report Form
  • Case Action > Open > Batch
  • LAM > Local Affiliate > Report Distribution
  • LAM > Local Affiliate > Report Submission (Submitted Reports/Non-Submit reports)
  • LAM > Local Affiliate > Bulk Reporting

Validation and attachments

The MedWatch Drug report is generated without any minimum data requirements. However, an error message is displayed when you try to generate the MedWatch report for a reporting destination that is not configured with the MedWatch profile (standard or custom).

The PDF attachments included in the Case Form > Additional Information > Notes and Attachments section are attached to the MedWatch report, if the Incl. Reg. Sub field is marked as per the existing functionality. The Appendix page prints details of the PDF attachments.

When MedWatch is selected in the Periodic Report selection criteria for PSUR, CTPR, and NDA, then the Reporting Destination drop-down displays only those agencies that has MedWatch profile (standard or custom) configured in the following sections.

• Reports > Periodic Reports > ICH PSUR or CTPR > Summary Tabulations > Additional Expedited Report Forms (CIOMS/MedWatch/VAERS)> Print MedWatch > Forms of Agency.
• Reports > Periodic Reports > NDA > Line Listing > Print MedWatch > Forms of Agency.

Note:

The existing Reporting Destination that are used for sending the MedWatch report must be updated by setting the Message profile to MedWatch drug report (standard or custom). If there are any Periodic reports that are configured to generate the MedWatch report, then make sure that the Reporting Destination is configured with MedWatch drug report profile (standard or custom).