sapphire rkt

8/10/2019 Sapphire RKT

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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

physician’s 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 ServerLog 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 interfacesthrough 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 Martthrough 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 accessthe 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 thedata 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.




Workflow and data entry

Case creation

• Case information received by AZ will be sent to a DataEntry Site (DES)

• DES user will check if the case is new.

• If it is a new case, the user logs the case into Sapphireand a case Id is created after the user successfullysaves the case for the first time.

• The system will automatically assign workflow tasks tothe case based on the case.




Workflow process

• The system generates workflow tasks based on theworkflow 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.




• 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 toTriage

- 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.




- Data Entry

• During this task all the information related to case will beentered like

• Patient information

• Event

• Lab

• Drug/dosing details etc.,

• At the completion of this step the case status is set toQRE

- 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.




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 casesthat 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 requiredcases

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

sapphire rkt

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