Topics in this section are:

• About Regulatory Reporting
• Scenario for Regulatory Reporting
• Process of Regulatory Reporting
• Setting Up Report Numbers
• Creating and Populating New Regulatory Reports (End User)
• Entering and Reviewing Data for 3500A Reports (End User)
• Entering and Reviewing Data for MDV Reports (End User)
• Running 3500A and MDV Reports (End User)
• Which Sections of the MedWatch 3500A Form Get Filled In?
• Generating Regulatory Report Numbers and Submitting Reports (End User)
• Reopening a Regulatory Report (End User)
• Creating Supplemental or Follow-Up Regulatory Reports (End User)
• Field Mapping for the MedWatch Report (Reference)
• Field Mapping for the MDV Report (Reference)
• About Configuring Buttons in Regulatory Reports