Electronic Conflict of Interest System Project Charter Purpose

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Electronic Conflict of Interest System
Project Charter
7/20/2015
Purpose
UC San Diego currently collects paper conflict of interest disclosure forms. The purpose of this project is
to create an electronic system that will integrate with other UC San Diego systems to automate and
facilitate the completion of conflict of interest disclosure forms for its employees and affiliates, as well
as streamline the Conflict of Interest (COI) Office reviews, compliance activities, administrative
processes and reporting.
High Level Objectives
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Facilitate the disclosure process for the UC San Diego research community by providing a seamless
and user-friendly, web-based electronic COI (eCOI) system
Ability to record, store, retrieve and generate reports on disclosure and review data from multiple
sources in a single eCOI “clearinghouse”
Integrate the eCOI system with Coeus to ensure accurate project information as well as trigger and
track disclosure requirements
Create customized multi-level branching questionnaires with mandatory questions based on
discloser responses
Persist disclosure data so discloser can update or certify as applicable
Ability for discloser to designate a proxy to assist with the questionnaire completion
Automate workflow for the review of negative disclosures and approval processes where
applicable
Decrease institutional risk through quicker processing of disclosure information and identification
of COI issues
Provide monitoring data and tools for high risk disclosure and COI relationships
Ability to track data and outcomes for IRC and COIMS activities
Ability to integrate with other systems for disclosure activity outside of Coeus and for training
tracking purposes (UC Learning Center)
High Level Deliverables / Scope (see Business Requirements Document for additional
details)
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Eliminate paper conflict of interest disclosure forms including the PHS, 700-U, 9510, addendum,
supplement and subrecipient forms
Disclosers and proxies submit and edit all disclosures electronically inclusive of annual and
updated disclosures
Integration with the following systems:
o Coeus – contracts and grants system
o Blackbaud – gifts system
o UC Learning Center - training system (PHS and COIR Reports)
Sponsors – REMS feed data integration via Coeus
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Dashboards for different roles
Automated notifications and messaging
User roles and access
Special handling/thresholds managed by the COI Office
File and documentation uploads
IRC and COIMS management
Letter routing
Reporting
Ongoing help desk support (technical issues) for users of the eCOI system
Data integration from legacy systems into eCOI1
Out of Current Scope
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eMTA system integration
eDisclosure system integration
Data warehouse
Service agreements2
Project Risks
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Resources
o Insufficient resources to properly maintain the eCOI system after initial implementation
 Changes to COI rules and regulations may require changes to eCOI system. If
sufficient resources are not dedicated to ongoing system support and
maintenance, there could be an increase in institutional risk of non-compliance
with COI rules and regulations.
 New releases of Click Commerce software will require regular patches/upgrades
to the server and Click system. If patching and system upgrades are not done
on a regular basis, the server, application and data will be at higher risk (e.g.
security vulnerabilities, unintended service disruptions, etc.).
 Changes to upstream or downstream systems that are interdependent with
eCOI may require that changes be made to the eCOI system in order to maintain
proper integration and ongoing functionality. If sufficient resources are not
made available to support these changes to the eCOI system, the system may
become unstable and/or stop working entirely.
Dependencies
o Building and maintaining integration with others business offices and their business
processes (e.g. OCGA, eRAP, HSSPPO, etc.) creates numerous interdependencies
between other systems and offices. Changes to any of these business offices or
business processes could negatively impact the eCOI process and system.
o Building and maintaining integration with others systems (e.g. Coeus, ALTNG, Data
Warehouse, etc.) will create system interdependencies. Changes to any of these
systems could negatively impact the eCOI system.
1
To be evaluated to determine if there will be an integration of the COI database data into the eCOI system or if
will maintain two separate data sources with compatible reporting (require PHS data from August 2012 forward).
2
To be evaluated in the future.
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Time to deliver
o ORA leadership has expressed a strong desire to move forward quickly with the
implementation of the eCOI system and have a solution in place that meets all
deliverables/objectives by December 2016.
Scope
o The Business Process Owner (see below) has requested that all COI disclosure forms are
launched to the research community simultaneously (after appropriate testing and user
group pilots). This could result in extending the time required to deliver and limit the
ability of the eCOI Project Team to make post-release improvements within the
specified time period.
o If scope is expanded, this could increase the amount of time and resources required to
deliver the new scope. If new resources are not provided, and/or time to deliver is not
adjusted, the eCOI Team will be unlikely to provide all deliverables within the time
frame expected by project stakeholders.
Communication, Training and Change Management
o Without appropriate levels of communication, training, outreach, and change
management, system users and/or interdependent business processes could be
negatively impacted (e.g. staff in one of the sponsored projects offices or departments
are not made aware of eCOI interdependencies with Coeus).
Change Management/User Acceptance
o Without effective change management and advertisement of the new disclosure
process to the campus community, there is risk that the community will choose not to
adapt to the processes of the new system. To mitigate this risk, the project team should
work together to ensure that the campus community sees the benefits of the eCOI
system and is willing to make the change from paper to an electronic system.
Legacy Data Migration
o Without a complete analysis of the COI legacy system data structure and establishing
the eCOI system architecture, there is risk that the current project resources will
not have the bandwidth required to produce an effective eCOI legacy data migration. A
legacy data migration requires vetting each legacy data source, writing detailed data
specifications to map legacy system fields to eCOI fields, and creation of scripting and
logic to transfer the data from legacy systems into eCOI’s database format and fields.
To mitigate this risk, the eCOI leadership team should allow time for the eCOI system
architecture establishment, allocate resources to do the data analysis to look at
the hours required to complete this task, and then consider if the time and resources
required to complete this effort are available.
Assumptions
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eCOI Help Desk
o eCOI help desk services will be overseen by the eRAP help desk teams, with
foreknowledge that eRAP help desk will monitor eCOI ticket volume metrics, and if the
eCOI help desk ticket volume cannot be efficiently managed with the current team
resources, The Project Sponsor will champion increasing eRAP help desk team resources
to meet an effective level of eCOI user support.
COI Legacy System Data Migrations
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Completion of a data migrations from the legacy COI systems into the eCOI
system provides a complete historical view of disclosures for historical reporting and
compliance evaluation. Marianne will champion eRAP resources and Sandon will
champion ACT resources to explore each legacy data source structure, write detailed
data specifications to map legacy system fields to eCOI fields, and create scripting and
logic to bulk import the data from legacy systems into eCOI’s database format and
fields.
Resources
Project resources include the people and systems that will allow us to provide project deliverables and
include the following:
Project Resources/Team
Name
Kim Coburn
Anthony Slay
Harrison Watts
Tony Lashley
Jason DeFay
Sandon Jurowski
Magda Stec
Tejas Parikh
Ge Zhang
Angie McMahill
Cindy Roulan
Xuemei Wang
Ann Berenbaum
Cheryl Wilson
Lars Hedbor
Lester Xue
David Propen
eRAP Help Desk
Marianne Generales
Coeus
Sponsors – REMS feed
data
Learning Center data
Blackbaud
Project Role
Business Analyst and Product Owner
System configuration/Developer
System configuration/Developer
eRAP Lead Business Analyst & Scrum Master
Coeus/ePD Subject Matter Expert
System Administrator
System Administrator
Production Control
Web Services (Coeus/Click integration)
Client/Project Champion/Business Process
Owner/COI Subject Matter Expert/Change
Manager
COI Subject Matter Expert
COI Subject Matter Expert
COI Subject Matter Expert
Click Project Manager and Business Analyst (if
needed)
Click Lead Technical Resource
Click Technical Resource
Click Business Analyst
eCOI Technical Support
Project Sponsor
Data Integration
Data Integration
Department
eRAP
ORA
ORA
eRAP
eRAP
ACT
ORA
ACT
ACT
COI
Data Integration
Data Integration
HR
Gifts
COI
COI
COI
Huron/Click
Huron/Click
Huron/Click
Huron/Click
eRAP
ORA
eRAP
eRAP
Each team member will have the following responsibilities under their project team role:
Name
Project Role
Responsibilities
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Kimberly Coburn
Business Analyst and
Product Owner
Translate COI business requirements into user
stories, which the Scrum team can utilize for
system development. Communicate with
project stakeholders to verify COI business
requirements development within the eCOI
system. Create a product backlog with the
story points and make recommendations on
how to order these items to deliver the highest
business value. Work with the team and
stakeholders to continuously improve product
backlog quality and the product team’s
understanding of the requirements. Create
Project Charter and Project Plans to present to
project stakeholders and maintain overall
project focus. Organize technical staff training
and lead scrum meetings. Communicate with
the Click team members, keep Click on
track with project budget and timeline.
Communicate with other departments to learn
their processes for effective integration of eCOI
with other business systems. Assist with
change management for internal and external
system users. Perform overall system testing
and communicate issues using HanSoft.
Provide user acceptance testing
scenarios/recommendations. Create user
training documentation for the eCOI system,
with the assistance of the COI team. Work with
project leadership to develop an effective
system rollout schedule. Analyze the legacy
COI data system structures for data migration
into eCOI. Create data mapping
documentation for a data script writer to let
them know which legacy system fields to place
in each eCOI field, and how to manipulate the
legacy data for migration in the correct format.
Perform data migration testing and work with
the data script writer to verify that the data has
been correctly migrated and is ready for use.
Compare standard Click COI reports versus
current UCSD COI reporting, create
specifications to change Click COI reports to
meet UCSD COI departmental needs, and
create specifications for custom UCSD COI
reports which have no basis in the Click COI
system. Work with report writer to test custom
reports and verify that they meet UCSD COI
departmental needs.
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Anthony Slay
System Configuration/
Scrum Development Team
Member
Harrison Watts
System configuration
Tony Lashley
eRAP Lead Business
Analyst & Scrum Master
Jason DeFay
Project Champion/Coeus
and ePD Subject Matter
Expert, eRAP Director
Complete the actual work of delivering the
product increment. Collaborate with other
team members to decide how to produce the
product to the definition of “completed.”
Present client demo and lead Sprint review
meetings. Forecast how much they can do in
one sprint and self-organize to get the work
done, decide among themselves who does
what to produce the new product increment.
Attend and participate in sprint planning
meeting. Perform unit testing and propose
additional story points which will assist with
overall development. Serve as the data script
and report writer.
Complete the actual work of delivering the
product increment. Collaborate with other
team members to decide how to produce the
product to the definition of “completed.”
Present client demo and lead Sprint review
meetings. Forecast how much they can do in
one sprint and self-organize to get the work
done, decide among themselves who does
what to produce the new product increment.
Attend and participate in sprint planning
meeting. Perform unit testing and propose
additional story points which will assist with
overall development.
Assist the product owner with understanding
how to create and maintain the product
backlog so the project is well defined and work
flows smoothly to the team. Work with the
Scrum team to determine the definition of
“completed.” Coach the team on how to
execute the Scrum process, helping them learn
and use the framework, and find and
implement technical practices, so they can
reach ‘done’ at the end of each sprint. Foster
the team's self-organization and see that
distractions and impediments or roadblocks, to
the team's progress are removed. Facilitate
regular team meetings, to ensure that the team
progresses on its path to done. Aid the Product
Owner in developing a leadership
approved effective system roll out schedule.
Act as the project’s champion and provide
direction and support to the project team.
Assists with navigating the intricacies of
transferring data between the eCOI and Coeus
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Sandon Jurowski
System Administrator
Magda Stec
System Administrator
Tejas Parikh
Production Control
Ge Zhang
Web Services (Coeus/Click
integration)
systems. Handles vendor contract negotiation
and submission for funding. Participate in
overall system development decisions and
allocate eRAP resources to enable effective
product development. Aid the Product
Owner in developing a leadership
approved effective system roll out schedule.
Reviews and approves eRAP resource
allocations.
Communicate eCOI infrastructure and system
environment needs to ACT (Hardware provider)
and provide those items to the eCOI team.
Work with applicable employees to ensure that
system upgrades are completed, and web
services access to systems which will feed into
eCOI are accessible. Participate in overall
system development decisions, allocating ACT
resources to enable effective product
development. Perform unit testing for the
system where applicable. Aid the Product
Owner in developing a leadership
approved effective system roll out schedule.
Champion all ACT resource requests. Assign
resources to work with Product owner to
create a data script, perform testing changes,
and push COI legacy data into the eCOI system.
Reviews and approves ACT resource
allocations.
Assist the project team with the upkeep,
configuration and reliable operation of
computer system, especially servers and Click
system upgrades.
Push new software development iterations
from development to quality assurance to
production.
Complete the actual work of delivering the
product increment. Collaborate with other
team members to decide how to produce the
product to the definition of “completed.”
Present client demo and lead Sprint review
meetings. Forecast how much they can do in
one sprint and self-organize to get the work
done, decide among themselves who does
what to produce the new product increment.
Attend and participate in sprint planning
meeting. Perform unit testing and propose
additional story points which will assist with
overall development.
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Angie McMahill
Client/Project
Champion/Business
Process Owner/COI
Subject Matter
Expert/Change Manager
Cindy Roulan
COI Subject Matter Expert
Act as the project’s champion and provide
direction and support to the project team.
Serve as a Business Process Owner and COI
subject matter expert, conveying information
regarding processes, procedures, and system
requirements to the Product Owner.
Communicate with the Product Owner to
ensure that required features are not missed or
misinterpreted in system development.
Provide business expertise and guidance to
Product Owner in order to meet compliance
needs. Open doors of communication with
other department leaders, for assistance with
systems which will integrate with eCOI.
Perform system acceptance testing and
communicate issues using HanSoft. Allocate
COI staff time and effort for the success of the
eCOI project. Participate in weekly project
update review meetings, daily scrum meetings,
and sprint review meetings. Facilitate effective
and collaborative COI process change
management, within the COI department and
to the UCSD community. Serve as the senior
marketing executive of the eCOI system to the
UCSD community. Communicate with USCD
departments to obtain volunteers for the eCOI
focus teams and pilot groups, for user
acceptance system testing. Assist Product
Owner by assigning resources to edit initial user
training materials and maintaining the end user
training materials thereafter. Aid the Product
Owner in developing a leadership
approved effective system roll out schedule.
Provide information about current processes,
procedures and eCOI system requirements to
the Product Owner. Perform system
acceptance testing and communicate issues
using HanSoft. Participate in weekly project
update review meetings, daily scrum meetings,
and sprint review meetings (all as assigned by
COI Director). Communicate with the Product
Owner to ensure that required features are not
missed or misinterpreted. Communicate the
internal and external system user needs and
streamline existing processes promoting an
adaptable eCOI system. Provide non-technical
support for the eCOI system users. Aid Product
Owner with primary system user training
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sessions, assume user training responsibilities
thereafter and keep user training materials up
to date, as assigned by the COI Director.
Xuemei Wang
COI Subject Matter Expert
Ann Berenbaum
COI Subject Matter Expert
Provide information about current processes,
procedures and eCOI system requirements to
the Product Owner. Perform system
acceptance testing, and communicate issues
using HanSoft. Participate in weekly project
update review meetings, daily scrum meetings,
and sprint review meetings (all as assigned by
COI Director). Communicate with the Product
Owner to ensure that required features are not
missed or misinterpreted. Communicate the
internal and external system user needs, and
streamline existing processes promoting an
adaptable eCOI system. Provide non-technical
support for the eCOI system users. Aid Product
Owner with primary system user training
sessions, assume user training responsibilities
thereafter, and keep user training materials up
to date, as assigned by the COI Director.
Provide information about current processes,
procedures and eCOI system requirements to
the Product Owner. Perform system
acceptance testing, and communicate issues
using HanSoft. Participate in weekly project
update review meetings, daily scrum meetings,
and sprint review meetings (all as assigned by
COI Director). Communicate with the Product
Owner to ensure that required features are not
missed or misinterpreted. Communicate the
internal and external system user needs, and
streamline existing processes promoting an
adaptable eCOI system. Provide non-technical
support for the eCOI system users. Aid Product
Owner with primary system user training
sessions, assume user training responsibilities
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Department
Volunteers
Focus Team/Pilot Group
eRAP Help Desk
Technical eCOI Support
Lars Hedbor
Click Commerce
Developer/Technical
Trainer
Lester Xue
Click Technical Resource
thereafter, and keep user training materials up
to date, as assigned by the COI Director.
Perform user acceptance testing, by evaluating
each user story function in the eCOI, and
documenting whether the system function
returns the expected result. Provide feedback if
the system functions in eCOI adequately meet
the needs of the system user. To give insight
about how they would use
different components of the system in their
departments and provide suggestions for
system enhancements.
Deliver technical service and support to eCOI
end-users, by providing information in
response to inquiries, concerns and requests
about technical system issues. Gather
customer’s information and find the issue by
evaluating and analyzing the symptoms and
working with the development team to create
a solution to resolve the challenge.
Lead technical Click training and assist Product
Owner as needed. Complete the actual work of
delivering the product increment. Collaborate
with other team members to decide how to
produce the product to the definition of
“completed.” Present client demo and lead
Sprint review meetings. Forecast how much
they can do in one sprint and self-organize to
get the work done, decide among themselves
who does what to produce the new product
increment. Attend and participate in sprint
planning meeting. Perform unit testing and
propose additional story points which will assist
with overall development.
Complete the actual work of delivering the
product increment. Collaborate with other
team members to decide how to produce the
product to the definition of “completed.”
Present client demo and lead Sprint review
meetings. Forecast how much they can do in
one sprint and self-organize to get the work
done, decide among themselves who does
what to produce the new product increment.
Attend and participate in sprint planning
meeting. Perform unit testing and propose
additional story points which will assist with
overall development.
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David Propen
Business Analyst
Cheryl Wilson
Click Project Manager and
Business Analyst (if
needed)
Marianne Generales
Project Sponsor
To serve as COI system expert on the vendor
side. Assisting the Product Owner, by providing
insight through his experience with other
institutional Click COI implementations and
adding guidance through the Click COI
implementation process.
Serve as a system mentor in the effective use of
the existing COI module in Click and collaborate
with UCSD developers to add enhancements
and modification to best meet the needs of
UCSD.
Ensure that the business need is valid and
correctly prioritized. Ensure that the project is
properly launched and that the project remains
a viable business proposition. Ensure that
project scope is clearly established and changes
to the project scope are properly managed and
resourced. Ensure risks are managed and that
the project is under control. Approve key
project deliverables and resolve issues
(typically competition for resources and priority
clashes) that are beyond the control of the
Project Team. Resolve conflict and remove
obstacles which impede on the overall quality
of the project, both the methods used to
develop it and the end product. Provide
resources for the successful implementation of
the deliverables described in this document.
Reviews and approves Office of Research
Affairs resource allocations.
Project Budget
The Office of Research Affairs, ACT and eRAP will each contribute financial resources to support the
design, implementation and maintenance of the eCOI system. A copy of the estimated project budget is
attached as Appendix B.
Systems and Tools
The following systems and tools are expected to be used to meet the objectives of this project:
 Server hardware (ACT) and Click (Temporary)
 Click Portal with COI Module (Vendor/Huron)
 Microsoft SQL Server
 Team Foundation Server – Source Control (RAIT Support)
 Hansoft - task and project management (RAIT Support)
 BLINK – Web Content Management Server (ACT)
 Enterprise Architect – Mock up creation
 Free Mind – Process Diagraming
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Visio – Process Diagraming
MS Word – System Documentation
Change Management
The change management plan will facilitate an organized approach to support the control of change
requests during the eCOI project life cycle. In order to effectively perform change management for the
eCOI project, the Project Team will use the ADKAR3 Model.
The following procedures will be used for any change that will increase project scope beyond what has
been established in this document:
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Requests for changes from the eCOI project scope will be routed to the Product Owner. The
Product Owner will facilitate the review of the request.
The eCOI leadership team is made aware of any deviations from the baseline project scope, and
must agree upon a desire to carry out the change
Deviations from the baseline project scope cannot be implemented without verified and
validated eCOI leadership team agreement
The eCOI leadership team will review the change request form4 submitted, and request
additional information if needed to gain knowledge about if the change will cause a high level of
risk to the success of the baseline project
If the eCOI leadership team finds the risk caused by the change can be mitigated to an efficient
level, they will reach solutions for the budgetary, resource and timeline constraints, and the
development team's ability to execute this change within the eCOI system
The signing of the change request form by each leadership team member, will serve as Approval
for integration of the change into the project baseline scope
The Product Owner will create or modify user stories in the product backlog to carry out the
business need
Sponsors and Leadership
This project is sponsored by the Office of Research Affairs (ORA) and will be facilitated by the Electronic
Research Administration Program (completed as an “electronic” research system). The eCOI Project
Leadership Committee will be responsible for overseeing the successful implementation of the Project,
prioritizing deliverables as needed, championing the project, removing impediments to achieving
objectives and resolving issues, as they arise. Members include:
Name
Marianne Generales
Jason DeFay
Angie McMahill
Sandon Jurowski
Title
Assistant Vice Chancellor for Research and eRAP Executive
Committee Chair
Director, Electronic Research Administration Program
Director, Conflict of Interest Office
Manager, Enterprise Research Information Systems
Department
ORA
eRAP/ORA
COI/ORA
ACT
3
Awareness of the need for change, Desire to support and participate in the change, Knowledge of how to change,
and Reinforcement to sustain the change. See http://www.change-management.com/tutorial-adkaroverview.htm for details.
4
See Appendix A
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The Electronic Research Administration Program (eRAP) is sponsored by Sandra Brown, Vice Chancellor
for Research and the Campus Budget Office. It has an Executive Committee that provides leadership
and support for eRAP projects and it has a Steering Team that is responsible for providing high-level
guidance, support and strategic direction to eRAP staff.
Approval
By signing this document, the following individuals agree that they have reviewed the information
contained in this project charter and give their approval to formally begin the project.
Name
Marianne
Generales
Title
Assistant Vice Chancellor
for Research and eRAP
Executive Committee Chair
Signature
Date
6/26/15
Angela
McMahill
Director, Conflict of
Interest Office
7/14/15
Jason DeFay
Director, Electronic
Research Administration
7/7/15
Sandon
Jurowski
Manager, ACT ERIS Team
7/2/15
Approval_Email_MG
.pdf
RE eCOI Project Charter - Final.msg
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Appendix A
Change Request Form:
Change Requested By:
Status:
Date Change Requested:
Change Type:
Target Date to Completed:
Change Summary:
Priority:
Detail Description:
Evaluation Summary:
Total Cost:
Impact on Base System:
Comments:
Implementation:
Status: (Approved or Disapproved):
Phase:
Additional Implementation Details:
Approval:
By signing this document, the following individuals agree that they have reviewed the information
contained in this Change Request Form and agree to the request status.
Name
Marianne Generales
Angela McMahill
Jason DeFay
Sandon Jurowski
Title
Assistant Vice Chancellor for
Research and eRAP Executive
Committee Chair
Director, Conflict of Interest Office
Director, Electronic Research
Administration
Signature
Date
Manager, ACT ERIS Team
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