Electronic Conflict of Interest System Project Charter · 2020-04-06 · 1 | P a g e c:\users\smmccloskey\desktop\ecoiprojectcharter07202015.docx Electronic Conflict of Interest System

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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 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) 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


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 eMTA system integration

eDisclosure system integration

Data warehouse

Service agreements2

Project Risks 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.


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 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


o 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 Project Role Department

Kim Coburn Business Analyst and Product Owner eRAP

Anthony Slay System configuration/Developer ORA

Harrison Watts System configuration/Developer ORA

Tony Lashley eRAP Lead Business Analyst & Scrum Master eRAP

Jason DeFay Coeus/ePD Subject Matter Expert eRAP

Sandon Jurowski System Administrator ACT

Magda Stec System Administrator ORA

Tejas Parikh Production Control ACT

Ge Zhang Web Services (Coeus/Click integration) ACT

Angie McMahill Client/Project Champion/Business Process Owner/COI Subject Matter Expert/Change Manager

COI

Cindy Roulan COI Subject Matter Expert COI

Xuemei Wang COI Subject Matter Expert COI

Ann Berenbaum COI Subject Matter Expert COI

Cheryl Wilson Click Project Manager and Business Analyst (if needed)

Huron/Click

Lars Hedbor Click Lead Technical Resource Huron/Click

Lester Xue Click Technical Resource Huron/Click

David Propen Click Business Analyst Huron/Click

eRAP Help Desk eCOI Technical Support eRAP

Marianne Generales Project Sponsor ORA

Coeus Data Integration eRAP

Sponsors – REMS feed data

Data Integration eRAP

Learning Center data Data Integration HR

Blackbaud Data Integration Gifts

Each team member will have the following responsibilities under their project team role:

Name Project Role Responsibilities


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.


Anthony Slay System Configuration/ Scrum Development Team Member

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.

Harrison Watts System configuration 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.

Tony Lashley eRAP Lead Business Analyst & Scrum Master

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.

Jason DeFay Project Champion/Coeus and ePD Subject Matter Expert, eRAP Director

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


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.

Sandon Jurowski System Administrator 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.

Magda Stec System Administrator Assist the project team with the upkeep, configuration and reliable operation of computer system, especially servers and Click system upgrades.

Tejas Parikh Production Control Push new software development iterations from development to quality assurance to production.

Ge Zhang Web Services (Coeus/Click integration)

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.


Angie McMahill Client/Project Champion/Business Process Owner/COI Subject Matter Expert/Change Manager

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.

Cindy Roulan 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.

Xuemei Wang 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.

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.

Department Volunteers

Focus Team/Pilot Group 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.

eRAP Help Desk Technical eCOI Support 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.

Lars Hedbor Click Commerce Developer/Technical Trainer

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.

Lester Xue Click Technical Resource 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.


David Propen Business Analyst 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.

Cheryl Wilson Click Project Manager and Business Analyst (if needed)

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.

Marianne Generales Project Sponsor 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


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:

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:

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-adkar-overview.htm for details. 4 See Appendix A

Name Title Department

Marianne Generales Assistant Vice Chancellor for Research and eRAP Executive Committee Chair

ORA

Jason DeFay Director, Electronic Research Administration Program eRAP/ORA

Angie McMahill Director, Conflict of Interest Office COI/ORA

Sandon Jurowski Manager, Enterprise Research Information Systems ACT

http://www.change-management.com/tutorial-adkar-overview.htm

http://www.change-management.com/tutorial-adkar-overview.htm


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 Title Signature Date

Marianne Generales

Assistant Vice Chancellor for Research and eRAP Executive Committee Chair Approval_Email_MG

.pdf

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

RE eCOI Project Charter - Final.msg

7/2/15


Appendix A

Change Request Form:

Change Requested By: Status:

Date Change Requested: Change Type:

Target Date to Completed: Priority:

Change Summary:

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 Title Signature Date

Marianne Generales Assistant Vice Chancellor for Research and eRAP Executive Committee Chair

Angela McMahill Director, Conflict of Interest Office

Jason DeFay Director, Electronic Research Administration

Sandon Jurowski Manager, ACT ERIS Team

Documents

Electronic Conflict of Interest System Project Charter · 2020-04-06 · 1 | P a g e c:\users\smmccloskey\desktop\ecoiprojectcharter07202015.docx Electronic Conflict of Interest System