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					           A presentation about with
  Automating Data Entry Workflowthe scanned
            least used functionality
    CRF pages using DCAPI and OC Workflow
               in Oracle Clinical
                    System
                 Reliable Lifesciences Consulting
                     Torsten Adam, Partner




September 2006           http://www.pharmasol.de    1
                                               Agenda
 • Objective
 • Motivation
 • How does Oracle Clinical support Workflows?
    – Definition
    – Implementation
 • A Workflow example
 • Demo (Screenshots)
 • Issues during implementation
    – Functional
    – Technical
 • Questions

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                                                     Objective

 Current Workflow:
 Data Entry from Paper CRFs.


         Change:
         Implementation of CRF Tracking System


                 New Workflow:
                 1. Automatic Login of Received Pages
                 2. Data Entry from scanned images of CRFs.
                 3. Implementation of Workflow System
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                                                           Motivation
Paper Process                  eCRF Process Advantage

Delay&Distribution issue        Immediate DE upon receipt, no more sorting

Control&Tracking issue          Check Study Privileges and create statistics

Priorization&
Communication issue             Flexible, dynamic priorization of tasks and studies


Security/Logistics issue        CROs get no more paper, improved security


Costs                           Storage, shipment, printing, work w/ all CROs, ...


Quality issue                   Paper from NCR copy, scanned from original



  September 2006           http://www.pharmasol.de                             4
    How does Oracle Clinical support Workflows?
                    Definition




September 2006     http://www.pharmasol.de        5
                                   How does OC support Workflows?
                                                       - Definition

What Oracle says in the API manual:
• The Oracle Clinical data entry process can be integrated
  with external workflow and imaging systems.
• Data Capture API (DCAPI) to insert, update and delete
  patient data in Oracle Clinical.

What it means:
 An integrated OC Workflow System can give you
 full and immediate control over the Data Entry process
 with system wide, study specific and down to data entry
 operator specific settings.


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                                         How does OC support Workflows?
                                                             - Definition

   Our workflow system consists of two independent tools




          Workflow Logic
        In PL/SQL Library         &                            DCAPI
                                                      Library of C-procedures




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                                  How does OC support Workflows?
                                                      - Definition

Where can I use the Workflow System?

• Data Entry
   – Complete control of Data Entry Process




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                                  How does OC support Workflows?
                                                      - Definition

Where can I use the Workflow System?

• Discrepancy Management System
   – Open corresponding
     CRF page for a
     discrepancy




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                                  How does OC support Workflows?
                                                      - Definition

Where can I use the Workflow System?

• When working with DCFs
  – display DCFs and
    set DCF status




September 2006      http://www.pharmasol.de                    10
             What is the Workflow System?
                    Implementation




September 2006        http://www.pharmasol.de   11
                                                                                What is the Workflow System?
                                                                                             - Implementation
      Workflow Setup Overview

                            Oracle Clinical                                DC API                3rd party tools

                                            Insert, Updates, Deletes


                                                                               dcapi.h
                                                                                                                       T
                                                                                                                       R   S
                                                                                                         Interface     A   Y
                                                                                                        Application
                          Oracle
                                                 DCAPI Roles                  dcapi.lib
                                                                                                                       C   S
                                             OCLAPI_KEY_CHANGES
        Admin
                          Clinical           OCLAPI_UPDATE                                                             K   T
                                             OCLAPI_BROWSE
                                             ...                                                                       I   E
      defines                                                                                                              M
                       RXCLBCLI.PLL
                                                                              dcapi.dll
                                                                                                                       N
                      - Workflow Logic -                                                                               G

                use                        use
                         use

                                                                       Needs to be compiled using Pro*C 8.0.6.0.0


           User 1                           User 3
                          User 2
September 2006                                      http://www.pharmasol.de                                           12
                                        What is the Workflow System?
                                                     - Implementation



                   The issue is not to
          program the logic or to use the DCAPI.

               The main challenge is to
    define the Workflow and the processing logic.




September 2006        http://www.pharmasol.de                      13
                                          A Workflow example

The Workflow Logic needs to take over tasks normally
  covered by Oracle Clinical or the DE operator, like
• provide access to valid studies only, e.g. exclude frozen
  studies
• enforcing security constraints like study accesses, 1st
  and 2nd pass privileges
• assign documents to users
• lock currently processed pages from other users
• assign correct entry task for each document
• ...



September 2006        http://www.pharmasol.de             14
                                                                                             A Workflow example
     psiTrack Queues Overview

                                                                                       nto
                                                                                     si
     External System                                                            r ite
                                                                               W




                                                                                                                                                      DCAPI
                                   Exception                        Received                 1st Pass            2nd Pass                Other
     Defined Queues                 Queue                            Queue                    Queue               Queue                  Queue

                                      ID -1                           ID 0                     ID 1                   ID 2                ID 3




                                                                                                                                                              Workflow Logic in RXCLBCLI.PLL
                                   Re-Scan,                    First Pass,               Second Pass,          Browse,                  Update,
     Applied Workflow Action      Manual Action               OC Data Entry              OC Data Entry       OC Data Entry            OC Data Entry


     psiTrack
     Dequeue / Enqueue                                                       Workflow Logic and Privileges



     Users
     Dequeue / Enqueue


                                 Subscriber to
                                Exception Queue


                                              User Admin

                                                                             Subscribers to all Queues


                                                                                User B                       User D                         User F
                                                           User A                               User C                       User E




September 2006                                      http://www.pharmasol.de                                                                                                               15
                                           Demo




September 2006   http://www.pharmasol.de      16
                                           Demo (ctd.)




September 2006   http://www.pharmasol.de            17
                 Issues during Implementation
                          Functional




September 2006           http://www.pharmasol.de   18
                                          Issues during Implementation
                                                           - Functional

The main issues include

• Data Entry conducted outside of the Workflow System,
  incl. initial-logins, updates, key-changes and deletes of
  documents
• Distinguish between rescans and subevents of
  documents
• Ensure Maintainability, do not include too many rules,
  e.g. to assign documents to specific users
• Handling Page Status of 1st and 2nd Pass started



September 2006         http://www.pharmasol.de                       19
                 Issues during Implementation
                          Technical




September 2006           http://www.pharmasol.de   20
                                         Issues during Implementation
                                                           - Technical

The main issues include

• Multi-user functionality, locking pages
  Best Solution: use Oracles Advanced Queuing (AQ)
• Implement proactive messaging system to avoid pages
  are left over in queues
• Ensure user privileges are correctly retrieved from OC,
  e.g. when creating new roles
• No API for DCFs available




September 2006        http://www.pharmasol.de                       21
                 Questions?




September 2006   http://www.pharmasol.de   22

				
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