Oracle Argus Safety BI Publisher Periodic Reporting Extensibility Guide Release 8.1.1

73 Pages·2017·5.06 MB·English

by  Oracle Corporation

Oracle® Argus Safety
[1]
Flexible Reporting Extensibility Guide
Release 8.1.1
E87487-02
September 2017
Oracle Argus Safety Flexible Reporting Extensibility Guide, Release 8.1.1
E87487-02
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Contents
Preface................................................................................................................................................................. vi
Audience....................................................................................................................................................... vi
Where to Find More Information.............................................................................................................. vi
Revision History......................................................................................................................................... vii
Documentation Accessibility.................................................................................................................... vii
1 Introduction
2 Overview
Flexible Reports - What's in the Box..................................................................................................... 2-1
Output Formats........................................................................................................................................ 2-1
Scheduling................................................................................................................................................. 2-1
Report Templates...................................................................................................................................... 2-1
Database Code Wrapping....................................................................................................................... 2-1
3 Flexible Aggregate Reporting Framework
Generic Architecture................................................................................................................................ 3-1
4 Flexible Aggregate Reporting - Database
Database Architecture............................................................................................................................. 4-1
Flexible Aggregate Reporting - Database Objects......................................................................... 4-1
Tables................................................................................................................................................... 4-1
Views.................................................................................................................................................... 4-3
Database Link..................................................................................................................................... 4-4
Java Stored Procedure....................................................................................................................... 4-4
Packages.............................................................................................................................................. 4-4
Database Jobs...................................................................................................................................... 4-7
Argus Application Schema Objects...................................................................................................... 4-8
Tables................................................................................................................................................... 4-8
Packages.............................................................................................................................................. 4-8
Access Grants to BI Publisher Owner.................................................................................................. 4-8
5 Flexible Aggregate Reporting Design
Flexible Aggregate Reporting Design Structure................................................................................ 5-1
iii
BI Publisher Data Model................................................................................................................... 5-1
BI Publisher Report Layout.............................................................................................................. 5-4
Aggregate Report Data Flow.................................................................................................................. 5-4
Argus Safety UI Entry....................................................................................................................... 5-4
BI Publisher Data Flow...................................................................................................................... 5-5
6 Extending a Flexible Aggregate Report
Database Layer.......................................................................................................................................... 6-1
Configuration Extensibility.............................................................................................................. 6-2
Extending with User Exits................................................................................................................ 6-2
Extending Global Temporary Tables.............................................................................................. 6-4
Extending using Custom Objects..................................................................................................... 6-4
Adding or Modifying a View........................................................................................................... 6-5
Adding a Column to the Existing Table......................................................................................... 6-5
Extending the BI Publisher Data Model.............................................................................................. 6-5
Data Model Query Naming Convention........................................................................................ 6-5
Data Model Nested Queries............................................................................................................. 6-6
Data Structure Groups....................................................................................................................... 6-7
DSUR Summary Table Naming Conventions............................................................................... 6-8
Case Series Tables.............................................................................................................................. 6-9
Lexical Parameters.......................................................................................................................... 6-10
Creating a Custom Report................................................................................................................... 6-12
Blinding Functionality......................................................................................................................... 6-15
Flexible Data Re-categorization.......................................................................................................... 6-16
7 PMDA E2B (R3) Paper Forms - Framework
Generic Architecture - PMDA (R3) Paper Reports............................................................................ 7-1
8 PMDA (R3) Paper Report - Database
PMDA E2B (R3) Paper Report - DB Architecture.............................................................................. 8-1
DB Objects........................................................................................................................................... 8-1
Tables................................................................................................................................................... 8-1
Java Objects......................................................................................................................................... 8-2
Packages.............................................................................................................................................. 8-2
Argus Application Schema............................................................................................................... 8-3
ACCESS GRANTS to BI Publisher Owner..................................................................................... 8-3
9 PMDA (R3) Paper Report Design
BI Publisher Periodic Reports Design Structure................................................................................ 9-1
PMDA (R3) Data Model.......................................................................................................................... 9-1
Data Set............................................................................................................................................... 9-1
Event Triggers..................................................................................................................................... 9-2
Parameters........................................................................................................................................... 9-2
PMDA (R3) Paper Report templates..................................................................................................... 9-4
Argus Safety UI Entry....................................................................................................................... 9-4
iv
10 Extending PMDA (R3) Report
Database Layer....................................................................................................................................... 10-1
Extending the BI Publisher Data Model........................................................................................... 10-2
Extending through E2B PMDA Profile............................................................................................. 10-3
Configuring Blinding for PMDA (R3).............................................................................................. 10-5
10.4 Configuring Blinding for PMDA (R3).................................................................................. 10-5
A Troubleshooting
BIP Icon not Displayed Against Corresponding BIP Specific Fields in the Periodic Reporting
Configuration........................................................................................................................................... A-1
BI Publisher Periodic report does not Execute from Argus UI....................................................... A-2
Database Connection Errors.................................................................................................................. A-3
BI Publisher Scheduled Report Output does not Show up............................................................ A-3
ORA-01427: single-row sub-query returns more than one rowORA-06512: at "<bip_
owner>.PKG_AGG_RPT" for p_updclinicaldrugrole procedure.................................................. A-3
Troubleshooting PMDA (R3) Paper Forms........................................................................................ A-4
Troubleshooting Flexible Aggregate Reports.................................................................................... A-5
v
Preface
BI Publisher Periodic Reporting enables flexible handling of periodic reports in Argus
Safety. The Oracle Argus Safety Flexible Aggregate Reporting (Oracle Argus FAR) Guide
provides Argus Safety–BI Publisher integration details, and out-of-the-box periodic
report details along with data models, algorithms, and methods to customize or
extend these reports as needed.
Audience
This guide assumes that your organization has the expertise to perform the job
functions listed in this section. If your staff lacks these skills, we recommend that you
engage Oracle Health Sciences Consulting.
Oracle Database Administrators
Customizing the database package supplied with Oracle Argus FAR requires a level of
knowledge equivalent to having mastered the material in Oracle's DBA Architecture
and Administration course. You must be able to read SQL*Plus scripts and edit them.
You must be able to run SQL scripts and review logs for Oracle errors.
System Administrators
Customizing and maintaining an Oracle Argus Safety BI Periodic Reporting requires
mastery of the following tools:
■ Microsoft Windows Operating System
■ Unix or Linux based Operating Systems
■ OBIEE and (or) Oracle BI Publisher
■ Oracle Web Logic Administration
Where to Find More Information
Oracle Help Center
The latest user documentation for Oracle Health Sciences products is available at
http://docs.oracle.com/en/industries/health-sciences/.
My Oracle Support
The latest release notes, patches and white papers are on My Oracle Support (MOS) at
https://support.oracle.com. For help with using MOS, see
https://docs.oracle.com/cd/E74665_01/MOSHP/toc.htm.
vi
Revision History
September 2017: Updated format for OHC. No content change.
Documentation Accessibility
For information about Oracle's commitment to accessibility, visit the Oracle
Accessibility Program website at
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.
Access to Oracle Support
Oracle customers that have purchased support have access to electronic support
through My Oracle Support. For information, visit
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info or visit
http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing
impaired.
vii
1
Introduction
1
Argus Safety Flexible Reporting leverages the capabilities of the Oracle BI Publisher
reporting solution for Argus Safety Reports. This solution helps customers overcome
the challenges of periodic reporting to meet a variety of business needs.
This document provides Argus Safety–BI Publisher integration details, describes the BI
Publisher Periodic Reports framework, and describes ways to customize the report as
per customer needs.
This document also talks about the PMDA (R3) Paper Reports Framework using BI
Publisher.
Introduction 1-1
Oracle® Argus Safety Flexible Reporting Extensibility Guide
2
Overview
2
This chapter provides an overview of the product.
2.1 Flexible Reports - What's in the Box
Periodic Reports
■ Periodic Benefit Risk Assessment Report (PBRER)
■ Development Safety Update Report (DSUR)
■ The Post Marketed Aggregate Report (PMAR, also called PSUR)
Expedited Reports
■ PMDA R3 Paper Forms 1-6
2.2 Output Formats
Out-of-the-box Argus Safety BI Publisher reports support the following output
formats by default:
■ PDF
■ RTF
You can also get the output in an XML format. The out-of-the-box reports are not
designed to support the CSV format. However, you can prepare a custom report
supporting the CSV format.
2.3 Scheduling
Oracle Argus Flexible Reporting Framework supports Quartz scheduler.
2.4 Report Templates
Out-of-the-box (OOTB) Argus Flexible reports use RTF templates.
2.5 Database Code Wrapping
All Argus Safety objects are code wrapped. However, to facilitate and encourage
customers to handle their own customizations, the system does not wrap database
code under the (BIP Owner User).
Overview 2-1