Agenda

Sapphire Overview

Sapphire
Sapphire is an A* Critical application which replaced Clintrace, the
application initially used by AZ for its global case handling system.
Sapphire is an Adverse Event Reporting System (AERS) which captures
clinical and post marketing adverse events.
Adverse events represent the significant results of the drugs during
physicians experiment such as from headache to fatal results.

Striking Features of Sapphire

Sapphire provides an enhanced workflow to enable easier and better use of

the case handling tool.

The cases are logged by AZ internal users into the Sapphire system.
Workflow tasks and activities are automatically generated to analyze and
evaluate the case based on the workflow rules.

Cases that are completed will be submitted as reports to regulatory

authorities like FDA, EMEA etc.
Reporting can be done either on an expedited basis or periodic basis
depending on the type of the case.
Periodic reports These reports are sent in regular intervals like quarterly,

annual etc.
Expedited reports- These are reports which are sent to regulatory authorities
only for single cases.

Sapphire Architecture
Sapphire architecture has three layers

The Presentation layer, also referred as user interface layer

Developed in Dot Net to take advantage for the rich user
control
Helps user to enter, maintain and view AE related data during
clinical trial

The Business processing layer

Has validations and other business rules in Java ,governing the
storage and viewing of clinical data
The middle layer , J2EE , has globally accepted framework

The Data maintenance layer

AE data is stored in Oracle 10g database
Data is maintained through Oracle procedures

Sapphire Architecture Overview

Sapphire Architecture Overview

DotNet application is deployed into the Xenapp server

The user logs into Xenapp Terminal Server

Log in details are validated with the help of Active Directory
Once the user is validated , the control moves to the Business
layer
Business layer interacts with Oracle database for data processing
Business layer also communicates with external interfaces
through MQ Server, AZIA and Cyclone
Oracle reports fetch data from LIVE schema.
The changes made to the LIVE schema are updated on a regular
basis to the ETL Stage Schema with the help of Oracle Streams.
Data from ETL stage is transmitted to Reporting Data Mart
through ETL process.
BO Reports fetch data from Reporting Data Mart through the
Universe

Security & Data Storage

Sapphire application encrypts and validates the credentials

entered by the user with Active Directory in order to access
the application.

The application uses Multiple Document Interface (MDI) style

to allow the user to open more than one case or search
screen at the same time.

Business layer is responsible for various validations that

occur during each data entry in the presentation layer which
is done through a service call.

Transaction Database maintains the flow of data which has

two stages, Live Stage and ETL stage an exact copy of each
other. The two stages are created in order to avoid the
traffic of data flow. Transaction Database maintains only the
data for current day which is processed into Reporting Data
Mart every 24 hours.

Reporting Data Mart has all the data of cases so far created
(from last 4 years) as it is the permanent data storage
system.

Security & Data Storage

Workflow and data entry
Case creation

Case information received by AZ will be sent to a Data

Entry Site (DES)

DES user will check if the case is new.

If it is a new case, the user logs the case into Sapphire

and a case Id is created after the user successfully
saves the case for the first time.

The system will automatically assign workflow tasks to

the case based on the case.

Security & Data Storage

Workflow process

The system generates workflow tasks based on the

workflow rules in the following scenarios:
- A new case
- Follow-up case
- Local reporting
Workflow step
Should be completed in sequence before case
closure
Ex. Log, Triage, QRE etc.

Security & Data Storage

The normal sequence of a workflow process is as follows:
Log Triage Data Entry QRE Close
All the above are workflow steps which should be completed
in the same sequence.
- Log
Initial details for a case is captured.
The case status at this point is Log
At the completion of this stage, the case status is set to
Triage
- Triage
Triage happens immediately after the Log Step.
Case category will be identified in this step.
Triage step will be auto completed by the system for
certain Case category values.
At the completion of this stage, the case status is set to
Data Entry.

Security & Data Storage

- Data Entry
During this task all the information related to case will be
entered like
Patient information
Event
Lab
Drug/dosing details etc.,
At the completion of this step the case status is set to
QRE
- QRE
The QRE user corrects any errors in the Triage and
data entry screens
- Close
Any user can close a case at any point of time.
At the time of case closure the user will fill in the
necessary details and close the case.

Security & Data Storage

Search & Advanced Search
Search
It has three tabs namely Search Search result and
Recently opened cases.
In Search tab a case can be searched based on fields
present in the tab.
The result of the search is displayed in the Search result tab
which is automatically moved once the search function is
over.
The Recently opened cases tab displays the list of cases
that were opened recently.

Advanced search

Users with a limited amount of technical knowledge can make use of Advanced Search
facility
This option is used to form queries which will be used to search and retrieve the required
cases
The users will be able to select the list of tables to be accessed, columns to be selected,
join conditions to be implemented, constant comparisons to be performed etc.
A SQL query is formed and displayed in the UI as and when selections are made.
Queries can also be saved with a user-defined name and can be reused.

Reporting
Cases that are completed will be submitted as reports to regulatory authorities like FDA,
EMEA etc.
Reporting can be done either on an expedited basis or periodic basis depending on the
type of the case.
Periodic reports These reports are sent in regular intervals like quarterly, annual etc.
Expedited reports- These are reports which are sent to regulatory authorities only for
single cases.
Once the reports reaches the authority the ACK file is sent back as an
acknowledgement else a NACK file is sent back as a negative acknowledgment.

IMPORT AND EXPORT

EXPORT
To send closed case data to other systems in AZ Two categories of E2B Export are
present:

Auto Export:
Case is exported automatically if is satisfies certain business rules.
When a case is closed, Sapphire validates the case data to see whether it satisfies the
business requirements for the export.
If it satisfies the rules, the case will be selected for export.
SE2B file will be constructed with the case data and sent to AZIA.
AZIA transforms the SE2B file to E2B format and sends to the intended receiver.

Manual Export:
Case is exported manually by the Sapphire users without checking for any business
rule.
The user selects a closed case and selects the Export option and the receiver to which
the case should be sent.
SE2B file will be constructed with the case data and sent to AZIA.
AZIA transforms the SE2B file to E2B format and sends to the selected receiver.

Once the file is selected for export the status of the file is scheduled for export in the
Pending export tab.
When the cron job runs the status is changed to exporting in the same tab.

After the report is exported the status is changed to Completed in the Export log tab or
if any error occurs the error will be shown in the Export log tab.

Import

Receive case data from other systems and load it in sapphire live database.
Two categories of E2B Import are present:
Auto Import:

E2B file is sent to AZIA by third parties and internal applications.

AZIA transforms E2B file to SE2B format and sends to Sapphire.
Sapphire processes the SE2B file and loads the case into Sapphire live database.
Manual Import:
Sometimes the users will have E2B files which they might want to load into Sapphire.
In this case, the user selects the E2B file through Sapphire Import option.
Sapphire sends the E2B file to AZIA for transformation.

AZIA transforms the E2B file to SE2B format and sends it back to Sapphire.
Sapphire processes the SE2B file and loads the case into Sapphire live database.
Once the case is imported into the application the status will be scheduled for import in
the Pending import tab.
When the cron job runs the status is changed to importing and it moves to Available
cases tab.
The cases with soft edit is accepted where as cases with hard edit is rejected.
The soft edit cases are selected and when add it moves to the next tab Selected cases.
Here the cases are selected and process data button is clicked then it is imported.

MC cases tab will have the cases that are imported from jasper.

.
The cases from jasper will have only certain data where we will have to add the
necessary data.
For adding the data the case should be locked.
Once the case is locked no other user will be able to process it.

Thank You