Case Selection

The system evaluates the list of cases applicable for section 6.3 using the following criteria and configuration options from ICH PSUR Configuration > Summary Tabulations screen.

The Identify Non-interventional Studies field is mandatory, and you must select at least one of the options if Include Section 6.3 is selected.

If you save the report configuration without selecting a rule or without selecting a Non-Interventional Study report type in the main inclusion criteria, an error message appears.

When you select the Include Section 6.3 option, the system evaluates the list of cases applicable for this section by the following methods and categorizes these cases into the following lists when populating temp tables:

• Non-Interventional Current cases: Using the main case list identified from the report inclusion criteria, further restricts it to only the Non-Interventional cases based on all rules that are selected, for the Identify Non-Interventional Studies field. This case list is referred to as Non-Interventional current case list.

  • If the Case Classification rule is selected, any case from the main case list qualifies if it has a case classification that matches Identify Non-Interventional Studies.

  • If the Observe Study Type rule is selected, any case from the main case list that has an Observe Study Type qualifies if it has a case classification that matches Identify Non- Interventional Studies.

  • From the main inclusion criteria, any case from the main case list that has a report type that matches a Non-Interventional Study as categorized in the report type flexible re-categorization code list qualifies.

• Non-Interventional Cumulative cases: Using the report inclusion criteria, identifies cumulative Non-Interventional cases for the report corresponding to the configured product and uses the Non-Interventional selected Non-Interventional rule. This case list is referred to as the Non-Interventional Cumulative case list.

• Spontaneous Current cases: Using the main case list identified from the report Inclusion criteria, identifies the Spontaneous Current case list by restricting it to cases that have a spontaneous report type (where report type code list values do not have the This type includes cases from clinical trials selected).

• Spontaneous Cumulative cases: Using the report Inclusion criteria, first identifies the Cumulative Main case list, corresponding to the configured product. Using this cumulative main case list, it then identifies the Spontaneous Cumulative case list by restricting it to cases that have a report type in which This type includes cases from clinical trials is not selected.

After the system identifies the four case lists in the temp tables, it prints the cumulative summary tabulation categorized into the Spontaneous, and Non-interventional columns:

• The Spontaneous column has two sub-columns based on seriousness of the event: Serious, and Non-serious.

• Both the Serious and Non-Serious columns under Spontaneous have two sub-columns: Interval, and Cumulative.

• The Non-interventional column has a sub-column, Serious, based on events that are serious.

• The Serious column under Non-Interventional has two sub-columns: Interval, and Cumulative.

The system prints the summary tabulation counts broken down by both System Organ Class (SOC) sorted in the international order, followed by Preferred Terms (PTs) in rows, sorted alphabetically. The report prints SOCs with zero counts if there are no events reported.

It uses the Spontaneous Current case list for determining the Interval counts under the Spontaneous column (stratified based on Seriousness) and the Spontaneous Cumulative case list for the Cumulative counts under the Spontaneous column (stratified based on Seriousness).

The system uses the Non-Interventional Current case list for the Interval counts under the Non-Interventional column (stratified based on Seriousness) and the Non-Interventional Cumulative case list for the Cumulative counts under the Non-Interventional column (stratified based on Seriousness).

The summary tabulation prints the Total Spontaneous Cumulative all sub totals for Spontaneous column as total of Spontaneous Cumulative Serious plus Spontaneous Cumulative Non-Serious counts.

This tabulation also uses the parameter Print Serious Adverse Events or Reactions.

Report Parameters to Print Reactions or Serious Events

The Print Serious Adverse Events or Reactions parameter prints serious adverse events (SAE) or serious adverse reactions (SAR) based on the value. This parameter can have following possible values:

• Print Serious Adverse Reactions (default)
• Print Serious Adverse Events

The system uses the most conservative causality approach for identifying reactions.

Most conservative causality means that either reported or company causality is defined for a combination of product and event.