Add PBRER Section 6.3 - Cumulative and Interval Summary Tabulations from Post-Marketing Data Sources

Field	Description
Include Section 6.3	Check this checkbox to include Section 6.3. By default, this is unchecked.
Cumulative Start Date	Enter the cumulative start date in this field. This field users to specify the Start Date of the Cumulative date range. If not specified, the start date is picked from the date specified in the Inclusion Criteria. If specified, the application ensures that the date entered is a valid date, and is before the Start Date specified in the Inclusion Criteria.
Identify Spontaneous Cases using Report Type	Allows you to select the study cases that use report type from the multi-select list box. The values that are populated here, come from the Report Type codelist where the values display the This type includes cases from clinical trials as NOT checked. Only those values are included, where Display is set to Yes, in order to be consistent with the Report.
Identify Non-interventional Studies (UNION of rules below)	This is a mandatory field, comprising three new rules to identify Non-Interventional Studies: (Case Classification, Report Type, and Observe Study Type). These three new rules are displayed as checkboxes and have a section label called Identify Non-interventional Studies (UNION of the rules below). This field is mandatory, which means that at least one of the options must be selected if Include Section 6.3 is selected. Along with the three options, there is a multi-select list box for each that is populated with values from the respective codelist (given below) for the corresponding option that the user selected: Case Classification is populated with values from Case Classification codelist. Report Type is populated with values from Report Type codelist Observe Study Type is populated with values from Case Classification codelist with ICSR code values that are not-null All values are included in this list, irrespective of the Display field for Case Classification and Observe Study Type codelists. Those values where Display for Report Type codelist is set to Yes, are also included. A + sign is displayed as a label, next to these options to indicate that it is a UNION of selections.