9 PMDA (R3) Paper Report Design

BI Publisher Periodic Reports Design Structure

This section provides an overview of the PMDA (R3) Paper forms data model and report layout. Oracle recommends you go through BI Publisher guides for more information.

Each report in PMDA (R3) paper reports has the following categories:

  • BI Publisher data model comprising parameters and XML file triggers

  • BI Publisher Layout templates

  • Database packages

PMDA (R3) Data Model

The BI Publisher data model comprises:

  • 9.2.1. Common data set for all PMDA (R3) paper report forms.

  • 9.2.2. Event triggers

  • 9.2.3. Parameters

Data Set

Common data set is used for all PMDA (R3) report forms. A data set is the XML data file used to generate the report output. The graphic below displays the data set of the PMDA (R3) data model.

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In the above diagram, each box represents a query.

Query Description
G_PMDA The main query used to fetch the data from the XML present in GTT_RPT_EXPD_XML
G_FAX Fetches the fax titles from profiles.
G_TITLE Fetches and derives the main report titles.
G_WMARK Prints the Draft on the top right corner of the report depending on the report executed.
G_LAB Fetches the lab test data for Form 2-3 section.

Event Triggers

The Before data trigger and the After data trigger are the two event trigger types.

The Before data trigger is the starting point of the report after submission. The Before data trigger executes the pkg_expd_rpt.f_before_data procedure. You can customize trigger names per your requirements.

The Before data trigger call to the pkg_expd_rpt.f_before_data package passes the following arguments:

  • XDO User name: The user logged in.

You can create multiple Before data triggers, and the system executes them in the arranged order.

The After data type trigger fires after the completion of the Before data triggers.

Parameters

Parameters are part of the data model. The graphic below displays the parameters of the PMDA (R3) Paper report.

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This data model contains only Text type parameters.

Parameter Description
PN_REPORT_FORM_ID This is the report form ID passed from the Argus UI to the BIP report. OOTB values are:

81: Marketed Form (1,2)

82: Marketed Form (3,4)

83: Marketed Form (5,6)

84: Investigational Form (1,2)

85: Investigational Form (3,4)

86: Investigational Form (5,6)
PN_PRINT_AS The watermark text is printed based on this parameter. For final report, no watermark is printed. The default value is Draft.
PV_MKT_INV The parameter is either M for Marketed or I for Investigational.
PN_J10_BLIND J10 element must be updated if the PN_J10_BLIND is 1, irrespective of the Blinded flag.
PN_PRT_UNBLIND If the user is authorized to access the blinded data, then he can either print/ not print the blinded data based on this parameter. For restricted users, this parameter is unused.
PN_IMP_(R3) This parameter is used to identify whether the report is to be generated through case import.

0 - Regular cases

1 - E2B Imported cases, but case is pending for save
PN_RPT_FAXHEADER Header value for FAX obtained from the profile configuration.
PV_RPT_CATG Report Category value used in deriving the PMDA Report title.
PN_REG_REPORT_ID This is a system parameter and should not be changed.
PN_REPORT_ID This is a system parameter and should not be changed.

All these parameters are passed from the Argus UI when the report is either run manually or through AG Services. Some parameters have been added but currently are not used by the report.

Note:

User cannot execute the PMDA (R3) paper report directly from BI Publisher. It can only be executed from Argus Safety.

PMDA (R3) Paper Report templates

There are 3 RTF templates for PMDA (R3).

  • Form 1-2

  • Form 3-4

  • Form 5-6

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Argus Safety UI Entry

The PMDA (R3) Paper forms are configured under the new flexible code list LM_REPORT_FORMS_EXPEDITED. The path of reports can be configured in these code lists as shown below.

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The columns present in this code list are used as shown here:

Column Description
CODE This is auto generated.
RPT_TYPE 0 = Expedited, 1 = Periodic.
FORM_CATEGORY This column is used to identify the category of report forms e.g. for all PMDA forms, it is 1; otherwise 0.
REPPATH The report path of the BI Publisher.
BIPREPTYP Report template value to be matched with CFG_RPT_AGG_PARAMS. Default value is 11.

The remaining columns are currently not used.