PMAR Sections

The PMAR includes the following Summary tabulations:

• Summary Tabulation for HCP
• Summary Tabulation for Consumer
• Summary Tabulation for Clinical Trials
• Cumulative Summary Tabulation for Serious Unlisted Events

The following Information is part of the PMAR Trailer Section:

• Case IDs without any qualifying drugs
• Case IDs without any qualifying events
• Labels configured for drugs in the drug list
• Cases with Missing Assessment

The PMAR considers parameters as per the sheet available in the PBRER specifications section for the column Required in PMAR? marked as Yes.

• PSUR Configuration.
• Oracle Business Intelligence Publisher report parameters.
• To support PMAR, a main case series and cumulative case series is generated based on the inclusion criteria defined in the PSUR configuration of Oracle Argus Safety. The system evaluates the list of cases from the main and cumulative case series to categorize them.
• Name