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									                      Monthly Status Report


         Cancer Adverse Events Reporting System (caAERS)
                          Status for June 2009




                             Paul Baumgartner
                         Project Manager - caAERS
                   paul.baumgartner@semanticbits.com

                        Submitted: July 10, 2009




SAIC-Frederick
Version 0
Monthly Status Report
caAERS
June 2009


Personnel Roster

                Name                                     Title/Role
Ram Chilukuri                       Project Director
Vinay Kumar                         Architect
Paul Baumgartner                    Project Manager / Business Analyst
Biju Joseph                         Lead Developer
Srini Akkala                        Lead Developer
Monish Dombla                       Senior Software Engineer
Sameer Sawant                       Senior Software Engineer
Ion Olaru                           Senior Software Engineer
Karthik Iyer                        Software Engineer & QA Lead
David Coffey                        Usability and UI Engineer
Sharon Elcombe                      Institutional Lead, Subject Matter Expert
Sonja Hamilton                      Institutional Lead
Jennifer Frank                      Subject Matter Expert
Jean Hanson                         Subject Matter Expert
Robbin Peterson                     Subject Matter Expert
Bradley Andersen                    Technical
Michael Carston                     Technical
Kimberly Johnson                    Institutional Lead, Subject Matter Expert
Amish Shah                          Technical Lead
Josh Yoder                          Technical
Robert Dale                         Technical
Nimesh Patel                        Technical
Debbie Sawyer                       Subject Matter Expert
Susan Sutherland                    Subject Matter Expert
Robin Heinze                        Subject Matter Expert
Allison Booth                       Subject Matter Expert
Bob Morrell                         Institutional Lead, Subject Matter Expert
Steven Cheng                        Technical
Kim Sweat                           Subject Matter Expert
Del Jones                           Subject Matter Expert
Michele Harmon                      Nurse - Subject Matter Expert
Insert additional rows as needed.




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Monthly Status Report
caAERS
June 2009


Description of Work Completed During the Month

Status Overview

This report covers the period from June 1 to June 30, 2009 and may also be referred to as
Iteration #1. This is the first month of a twelve month period of performance that may also be
referred to as Phase III of the caAERS development effort.

This iteration was highlighted by completion of responses to the caAERS v1.0 Silver Review,
completion of Phase I support of the Build Deployment Automation (BDA) process, caAERS
demonstrations to new potential adopters (Emory University, CCS Associates, and
Immunovative Therapies Ltd.), accelerating adopter support for current and new adopters,
hardening of the adverse event expedited reporting flow, significant progress by the adopter sites
in their testing and implementation of caAERS, significant implementation of new development,
and continued project management and technical support of the CTEP sponsored production
pilot of caAERS as an expedited reporting tool for AdEERS reporting.

During this period, the project team performed a variety of initialization and construction related
activities. Initialization efforts focused on project management and business analysis activities.
Project management efforts involved defining the scope and vision for this period of
performance, identifying the key requirements and use cases for implementation in the upcoming
iterations, and establish project logistics and plans needed to successfully execute this phase of
development. Project management efforts were also involved in recording, triaging, and tracking
the 98 new tasks/issues identified during this iteration. A kick-off meeting for this phase was
scheduled for 7/01/2009. Additional initialization activities focused on business analysis
activities related to elaboration and hardening of use cases including improvements to the
Review and Report screen, elaborating the use case for support of AdEERS 24hr notifications,
ensuring proper handling of deleted items associated with other objects, develop use case for
improving the advanced search module, harden use case for investigator and research staff user
creation, harden use case for supporting printing caAERS worksheets, and develop the use case
for system admin support in tracking AE report submissions. In order to complete the above
activities, project management and business analysis efforts heavily leveraged meetings with
team members, stakeholders, and elaborators. During this iteration, over sixty (60) meetings
were conducted involving significant project management or business analysis involvement.
These meetings include, twenty-two (22) daily scrums with the development team, twelve (16)
CCTS team scrums/meetings, fourteen (15) adopter calls, ten (10) separate bi-weekly meetings
with the VCDE mentor, SAIC COTR, BAM analyst, DCP stakeholders, and AdEERS technical
team, and several additional ad-hoc meetings.

The construction activities were pursued by the development team and involved implementing
several of the use cases elaborated upon earlier, along with support for the CCTS effort. CCTS
support largely involved changing the caAERS build process to conform with the BDA process.
The result of this effort is that caAERS can be automatically built on the NCI-dev tier via a
single command. Application related features and support were targeted on features supporting

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Monthly Status Report
caAERS
June 2009


the caAERS-AdEERS pilot and included improvements to the Review and Report screen,
implementing the use case for support of AdEERS 24hr notifications, ensuring proper handling
of deleted items associated with other objects, implementing the use case for improving the
advanced search module, implementing the use case for investigator and research staff user
creation, implementing the use case for supporting printing caAERS worksheets, and
implementing the use case for system admin support in tracking AE report submissions. There
were also improvements made to the usability of the application by adding javascript navigation
and utilizing the YUI technology in certain displays. Additionally, the team identified/logged 98
issues and resolved 108 issues.

Adopter activities remained significant and were focused on installation, configuration, technical
integration, and testing of v1.9.2 with progress continuing to be made at all adopter sites toward
the adoption of caAERS in a production setting. Elaboration activities involving adopters
continued to focus on hardening the requirements for the Routing and Review use cases and
improvements to the expedited reporting workflow. The team at Mayo continued their parallel
testing of AdEERS submissions where they will submit a production AdEERS and an AdEERS
via caAERS in a side-by-side fashion. A total of fifteen (15) reports have been tested with this
method. The CALGB team continued technical integration activities and instituted a weekly
group testing meeting which produces valuable feedback for the caAERS development team.
The Wake Forest team continued their progress toward production usage of caAERS.
Product demonstration activities involved a demonstration to the clinical trials management at
Emory University. This group is interested in caAERS, but primarily for the usage in non-cancer
clinical trials. Additional demonstrations were made to the I-SPY 2 team at CCS Associates (the
CRO conducting this trial). Aside from supporting the three project adopters (Mayo, CALGB,
and Wake), dopter support activities were largely coordinated through the CTMS Knowledge
Center and involved support for an Israeli company (Immunovative Therapies Ltd.), who will be
conducting a clinical trial in the US in support of an FDA IND submission, and Roswell Park
Cancer Institute, who has decided to implement caAERS. Roswell Park’s efforts have become a
valuable source of feedback for the caAERS project.
The project is currently on track and in line with achieving the goals of the project.




                                      External Meetings

      Date                              Topic                       Project Attendees (Optional)
Everyday            caAERS team scrum                             caAERS team
Every Tues, Wed,    CCTS team meeting                             CCTS team
Thurs
Every Friday        Status Updates w/ NCI-CBIIT (CCTS Project     CCTS team; CBIIT stakeholders;
                    Managers)                                     SAIC stakeholders
6/2/2009            caAERS Bi-weekly Project Status Briefing &    Paul Baumgartner, Peter Yan
                    Deliverable Review Meeting

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Monthly Status Report
caAERS
June 2009


6/3/2009       caAERS – BAM meeting                         Paul Baumgartner, Michele
                                                            Ehlman
6/4/2009       caAERS All-hands meeting                     Paul Baumgartner, stakeholders
                                                            from CBIIT, CTEP, DCP, BAM,
                                                            Mayo, CALGB, Wake, Roswell
                                                            Park
6/4/2009       CALGB – caAERS group meeting                 Paul Baumgartner, CALGB
                                                            caAERS team
6/8/2009       Roswell Park – caAERS group meeting          Paul Baumgartner, Roswell Park
                                                            caAERS team
6/8/2009       caBIG caAERS overview for Emory University   Paul Baumgartner, Bill Dyer,
                                                            Emory clinical trial management
6/8/2009       caAERS discussion with CCS Associates        Paul Baumgartner, Anne
               (Routing and Review demonstration)           Tompkins (DCP), Linda Doody
                                                            (CCSA), Dan Milgram (CCSA)
6/9/2009       caAERS discussion                            Paul Baumgartner, Ann Setser
                                                            (CBIIT)
6/10/2009      DCP – caAERS meeting                         Paul Baumgartner, Anne
                                                            Tompkins (DCP)
6/11/2009      Wake Forest – caAERS group meeting           Paul Baumgartner, WFU
                                                            caAERS team
6/11/2009      Mayo Clinic – caAERS group meeting           Paul Baumgartner, Mayo
                                                            caAERS team
6/11/2009      CALGB – caAERS group meeting                 Paul Baumgartner, CALGB
                                                            caAERS team
6/12/2009      caAERS – AdEERS integration meeting          Paul Baumgartner, AdEERS
                                                            technical team (CTIS), Shanda
                                                            Finnigan (CTEP)
6/15/2009      Roswell Park – caAERS group meeting          Paul Baumgartner, Roswell Park
                                                            caAERS team
6/15/2009      caAERS support call with Immunovative        Paul Baumgartner, Monish
               Therapies Ltd.                               Dombla, Immunovative
                                                            Therapies personnel
6/15/2009      caAERS Mentors meeting                       Paul Baumgartner, Lynne
                                                            Wilkens, Pankaj Agrwal
6/16/2009      caAERS support call with Immunovative        Paul Baumgartner, Monish
               Therapies Ltd.                               Dombla, Immunovative
                                                            Therapies personnel
6/16/2009      caAERS Bi-weekly Project Status Briefing &   Paul Baumgartner, Peter Yan
               Deliverable Review Meeting
6/17/2009      caAERS discussion with CCS Associates        Paul Baumgartner, Linda Doody
                                                            (CCSA), Dan Milgram (CCSA)


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caAERS
June 2009


6/18/2009            Wake Forest – caAERS group meeting                 Paul Baumgartner, WFU
                                                                        caAERS team
6/18/2009            Mayo Clinic – caAERS group meeting                 Paul Baumgartner, Mayo
                                                                        caAERS team
6/18/2009            CALGB – caAERS group meeting                       Paul Baumgartner, CALGB
                                                                        caAERS team
6/22/2009            Roswell Park – caAERS group meeting                Paul Baumgartner, Roswell Park
                                                                        caAERS team
6/23/2009            CTMS Workspace call                                Paul Baumgartner, CTMS WS
6/25/2009            Wake Forest – caAERS group meeting                 Paul Baumgartner, WFU
                                                                        caAERS team
6/25/2009            Mayo Clinic – caAERS group meeting                 Paul Baumgartner, Mayo
                                                                        caAERS team
6/25/2009            CALGB – caAERS group meeting                       Paul Baumgartner, CALGB
                                                                        caAERS team
6/29/2009            Roswell Park – caAERS group meeting                Paul Baumgartner, Roswell Park
                                                                        caAERS team
6/29/2009            caAERS support call – Roswell Park (login          Paul Baumgartner, Srini Akkala,
                     issues)                                            Ken Quinn (Roswell Park)
6/30/2009            caAERS Bi-weekly Project Status Briefing &         Paul Baumgartner, Peter Yan
                     Deliverable Review Meeting


                                       Technical Progress

                     Activity                                             Description
Build Deployment Automation (BDA) support             A CCTS support activity; requires the caAERS
(Phase 1)                                             build process to be moved to the NCI-dev tier and
                                                      comply with the BDA guidelines; Phase 1 of this
                                                      activity has been completed
Add security to web services                          caAERS web services did not have authentication
                                                      or authorization; this activity was to add this
                                                      support; this activity has been completed
Update caAERS grid service                            This activity was to update the caAERS grid service
                                                      and host a public grid service; this was done in-part
                                                      to support the .NET prototyping being developed by
                                                      NCI; this task is 75% complete; remaining work
                                                      includes creating a secure service.
Implement method of logging and managing report       caAERS report submissions can be sent via an
submissions                                           ESB or via email; this activity included adding a
                                                      method of logging for email based submissions and
                                                      developing an interface for an administrator to
                                                      review all report submission activity; this task is
                                                      50% complete.

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Monthly Status Report
caAERS
June 2009


Update caAERS to support certain AdEERS                           Updates to match business rules changes in the
changes                                                           AdEERS system for agents and decimals; this
                                                                  activity is complete
Implement improvements to the Review and Report                   This is the screen where the rules engine results
screen.                                                           are displayed and the reports to be completed and
                                                                  the AEs to report are selected; the improvements
                                                                  are to make this page more intuitive and support all
                                                                  expedited reporting scenarios; this activity is 50%
                                                                  complete.
Implement improvement to the Advanced Search                      This is the interface where users can query for
interface                                                         items in caAERS; updates were required to expand
                                                                  the queries that users could conduct on the system;
                                                                  this activity is 50% complete.
Implement navigation improvements                                 This activity involves implementing a javascript
                                                                  navigation framework where the user can hover
                                                                  over a tab and see the options available in that tab;
                                                                  this activity is complete
Implement performance improvements                                This activity involved compressing the javascript
                                                                  and CSS to improve performance; this activity is
                                                                  complete
Improve handling of deleted study objects                         This activity involved implementing a “soft delete”
associated with other objects                                     for all study objects; this activity is complete
Implement the ability to activate/inactivate research             This activity involves applying an active / inactive
staff and investigators                                           date for research staff and investigators on all of
                                                                  their roles; this activity is 25% complete
Implement the ability to associate research staff                 This activity involves significant changes the data
with multiple organizations                                       model for research staff, along with database, test
                                                                  case, UI, and API changes; this activity is 50%
                                                                  complete
Fix issues identified by stakeholders                             See the 6/2009 JIRA logs for details of the 108
                                                                  resolved tasks and the 98 reported issues.
Describe each discrete activity on which work was performed during the month. When the activity encompasses work on a discrete
task (see below), explicitly identify the task and task number.




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Monthly Status Report
caAERS
June 2009


Task Status

Discreet tasks are reported in a separate report (see the 6/2009 JIRA logs)

                  Task                               Status (% completed)      Comments




This section should include description of the current status for each task.




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Monthly Status Report
caAERS
June 2009


Work Planned for Next Month

                          Activity                                                      Description
Release caAERS v1.9.5                                             This will be a production release that will fully
                                                                  support AdEERS reporting and be used by Mayo in
                                                                  the caAERS-AdEERS production pilot.
Implement updates supporting AdEERS reporting                     This activity involves complying with updates to
                                                                  message schemas accepted by the AdEERS
                                                                  system; these updates are to support 24hr
                                                                  notification submissions and withdraws
Build Deployment Automation (BDA) support                         A CCTS support activity
(Phase 2)
Complete method of logging and managing report                    caAERS report submissions can be sent via an
submissions                                                       ESB or via email; this activity included adding a
                                                                  method of logging for email based submissions and
                                                                  developing an interface for an administrator to
                                                                  review all report submission activity; this task is
                                                                  50% complete.
Complete improvements to the Review and Report                    This is the screen where the rules engine results
screen.                                                           are displayed and the reports to be completed and
                                                                  the AEs to report are selected; the improvements
                                                                  are to make this page more intuitive and support all
                                                                  expedited reporting scenarios; this activity is 50%
                                                                  complete.
Complete improvements to the Advanced Search                      This is the interface where users can query for
interface                                                         items in caAERS; updates were required to expand
                                                                  the queries that users could conduct on the system;
                                                                  this activity is 50% complete.
Complete the ability to activate/inactivate research              This activity involves applying an active / inactive
staff and investigators                                           date for research staff and investigators on all of
                                                                  their roles; this activity is 25% complete
Complete the ability to associate research staff with             This activity involves significant changes the data
multiple organizations                                            model for research staff, along with database, test
                                                                  case, UI, and API changes; this activity is 50%
                                                                  complete
Describe each discrete activity on which work was performed during the month. When the activity encompasses work on a discrete
task (see below), explicitly identify the task and task number.




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Monthly Status Report
caAERS
June 2009


Issue Management and Lessons Learned

The monthly issue report is provided as a separate deliverable (see 6/2009 JIRA
logs)

   ID                 Issue         Owner        Actions    Priority    Status




Track issues from month-to-month.




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Monthly Status Report
caAERS
June 2009


Status of Deliverables

    Task ID                Deliverable/Milestone                 Delivery Date          Status
                                                                Draft submitted:     Draft
Task 1.1       Project Management Plan
                                                                6/24/2009            Submitted
                                                                Final due:
                                                                7/20/2009
Task 1.2       Monthly Status and Financial Reports             10th of each         Submitted
                                                                month                7/10/2009

Task 1.3       Project Summary Report                           At the
                                                                completion of
                                                                the project
Task 2.1       Updated caAERS Scope and Vision Document         Baseline
                                                                revision due:
                                                                7/20/2009
Task 2.2       Use Cases, and Software and System               Updated
               Requirements and Specifications or CFSS          regularly; Final
               and CFAS                                         due: 5/10/2010

Task 2.3       Updated UML Model, Architectures, and Master     Updated
               Design Document                                  regularly; Final
                                                                due: 5/10/2010
Task 2.4       Implementation Plan                              Due:
                                                                12/10/2009
Task 3.6       A Deployment Guideline of Multi-Site             Due:
               Protocol Study                                   12/10/2009
Task 4.1       Updated Master Test Plan, Test Scripts and       Test plan and
               Procedures                                       procedures due:
                                                                9/10/2009
                                                                Final test scripts
                                                                due at
                                                                completion of
                                                                project
Task 4.2       Completed Test activity logs, test result        10th of each         Submitted
                                                                month                7/10/2009
               reports, and bugs and fixes reports
Task 5         Compatibility Review Submission Package          2 weeks prior to
               including CDE Use Report, Annotated XML Files,   the completion
(Task 5.1 -
               API Document, Use Case, UML Model, SRSS,         of the project
Task 5.4)      SIW report, Test Logs, Technical Guide etc.)     performance
                                                                period
Task 6.1       Installation Package, Source Code, and Release   Included with
               Notes                                            each release
Task 6.2       Updated Installation Guide                       Regularly
                                                                updated on KC
                                                                wiki

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Monthly Status Report
caAERS
June 2009


                                                          Static copy due
                                                          at completion of
                                                          project
Task 6.3      Updated and maintained caAERS               Updated with
              Demonstration Web Site                      each release

Task 7        caAERS User Manual, Admin Guide,            Regularly
              Programmer Guide, and API documentation     updated on KC
                                                          wiki
                                                          Static copy due
                                                          at completion of
                                                          project
                                                          Due:
Task 3.1      AdEERS integration and support technical    10/10/2009
              document
                                                          Due: 8/10/2009
Task 3.2      Enterprise Service integration technical
              approach document
                                                          Due:
Task 3.3      CCTS SOA integration technical approach     12/10/2009
              document
                                                          Due:
Task 3.4      FDA ERSR support technical document         12/10/2009
                                                          Intial draft due 2   Updated:
Task 3.5      Maintained and revised caAERS Prioritized   weeks after          7/10/2009
              Feature List                                project starts
                                                          Due:
Task 3.6      Compliance Report for International AE      12/10/2009
              Report
                                                          Refer to the
Task 3.7      Quarterly adoption and KC support outline   Deliverable
              report                                      Management
                                                          Plan
                                                          Draft due:
Task 3.8      caAERS Compliance Reports for BRIDG,        10/10/2009
              BAM, and FDA regulations
                                                          Updated
Task 8.1      Reviewed and Commented Use Case             regularly; Final
              Documentation and SRS Document              due: 5/10/2010


                                                          Updated
Task 8.2      Critiqued Test Approach Document &          regularly; Final
              Adopter Test Approach Plan                  due: 5/10/2010


                                                          Updated
Task 8.3      Test Results Report                         regularly; Final
                                                          due: 5/10/2010
                                                          1 week prior to
Task 8.4      Reviewed and Commented End User             each release
              Guide’s

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Monthly Status Report
caAERS
June 2009


                                                                                         Due:
Task 8.5                Reviewed, Commented, and Approved                                12/10/2009
                        Developer’s Deployment Plan
For the first month, include all deliverables and milestones for the entire project. For subsequent months, update as necessary and
highlight any changes from the previous month. Add rows as needed.


External Dependencies

      Dependency                              Date                            Status                         Comments
Availability of Enterprise       7/10/2009                         Open                              Monitoring
Services
Updates to AdEERS                7/10/2009                         Open                              Monitoring
system


Note anything that the project needs from external sources and the status. This includes all interproject dependencies, government-
furnished information/equipment, decisions, etc. Add rows as needed.




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Monthly Status Report
caAERS
June 2009


Financial Reporting

Financial reporting will be provided in a separate report.




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