Project Charter - The Children's Hospital of Philadelphia - Research ...

Project Charter 

Pediatric Knowledgebase (PKB) 

‘Built for physicians by physicians’ 

Project ID 

Project Name 

Functional Area 

Relationship to Strategic Plan 

Pediatric Knowledgebase 

Division of Clinical Pharmacology & Therapeutics 

Prepared By 

Mahesh Narayan & S. Vijayakumar 

Date Initiated 10/7/2005 

Date Reviewed 

Date Approved 

Expected Implementation Time Frame 4Q 05 – 2Q 06 (Calendar)


Table of Contents 

1. EXECUTIVE SUMMARY ................................................................................................................. 3 

2. OVERVIEW........................................................................................................................................ 3 

2.1. BUSINESS CASE.............................................................................................................................. 3 

2.2. KEY STAKEHOLDERS...................................................................................................................... 3 

2.3. BUSINESS REQUIREMENTS .............................................................................................................. 3 

2.4. PROJECT OBJECTIVES ..................................................................................................................... 4 

2.5. CONSTRAINTS ................................................................................................................................ 5 

2.6. ASSUMPTIONS ................................................................................................................................ 5 

2.7. RISKS ............................................................................................................................................ 5 

2.8. IMPACTS ........................................................................................................................................ 5 

3. PROJECT DESCRIPTION................................................................................................................ 6 

3.1. SCOPE............................................................................................................................................ 6 

3.1.1. IN SCOPE.................................................................................................................................... 6 

3.1.2. OUT-OF-SCOPE........................................................................................................................... 6 

3.2. MILESTONES .................................................................................................................................. 6 

3.3. DELIVERABLES .............................................................................................................................. 7 

3.4. CRITICAL SUCCESS FACTORS.......................................................................................................... 7 

4. ESTIMATES ....................................................................................................................................... 7 

5. PROJECT COMMUNICATIONS AND CONTROL ....................................................................... 8 

5.1. PROJECT MANAGEMENT................................................................................................................. 8 

5.2. PROJECT COMMUNICATIONS........................................................................................................... 8 

5.3. RISK MANAGEMENT....................................................................................................................... 8 

5.4. ISSUE MANAGEMENT ..................................................................................................................... 8 

5.5. CHANGE MANAGEMENT................................................................................................................. 8 

APPENDIX A – PROJECT COMMUNICATIONS PLAN...................................................................... 9 

APPENDIX B - PROJECT ROLES AND RESPONSIBILITIES ...........................................................10 

PROJECT DOCUMENT APPROVAL....................................................................................................11 

REVISION HISTORY ..............................................................................................................................12 

GLOSSARY OF TERMS..........................................................................................................................12 

© The Children’s Hospital of Philadelphia Page 2 of 2 Nov. 8, 05 

Confidential and Proprietary Project Charter Template v2 20050408


1. Executive Summary 

The Pediatric Knowledgebase (PKB) is envisioned to be a physician resource for improving 

pharmacotherapeutic outcomes. It is an environment to discern information about medicines prescribed in 

pediatrics, to tailor therapy to individual profile, to forecast potential toxicity and rescue needs, to aid in 

understanding observed dose-response, Pharmacokinetic (PK), Pharmacodynamic (PD) data and to foster 

the use of clinical pharmacology in practice. The PKB will be constructed from data generated in our 

patients (for example, drug utilization, dosing guidance and clinical outcomes) as well as the available 

knowledge from various dosing compendiums, literature, and investigator-sponsored research at our 

institution. 

PKB will extend the information collected on pharmaceutical agents both inside and outside the 

institution to evaluate the individual therapeutic window for our patients when medicines are prescribed. 

Specifically, we will be able to provide expectations with respect to drug exposure, adverse events, side 

effects, drug interactions and clinical utility for various pediatric subpopulations in which drugs may be 

warranted. This project is funded through the Pediatrics Department Chair’s initiative for initial prototype 

development with the possibility of a non-competitive renewal for 2 additional years subject to satisfactory 

progress on the project deliverables. 

2. Overview 

2.1. Business Case 

This is a research project aimed at exploring ways to improve the quality of patient care at CHOP. A 

specific business case was waived for this project in lieu of the exploratory nature. 

2.2. Key Stakeholders 

Stakeholder 

Peter Adamson, MD 

Jeffrey S Barrett, PhD, FCP 

Mahesh Narayan, MB, MSE 

Sundararajan Vijayakumar, PhD 

Role 

Executive Sponsor 

Project Leader 

Project Manager - CHOP 

Project Manager - INTEK 

2.3. Business Requirements 

# High Level Business Requirements Alignment with Regulatory, 

Strategic, Tactical and/or 

Operational Goals* 

2.3.1 Create a pediatric knowledgebase for 

drugs in CHOP formulary from the 

collective experience at CHOP and share 

these findings on the Drug Dashboard 

Remarks 

(May include expected 

cost/benefit, ROI, etc) 

Provides comprehensive 

data, information and 

decision-analytics for the 

selected Drug and 

Disease Models 

(Indication) and serves 

as an on-line research 



# High Level Business Requirements Alignment with Regulatory, 

Strategic, Tactical and/or 

Operational Goals* 

2.3.2 Provide tools to compare individual 

therapeutic outcomes against historical 

trends 

2.3.3 Track and trend data by multiple 

variables for proactive management of 

patient care and safety 

2.3.4 Automatically alert key leaders of 

potential adverse events through defined 

algorithms 

2.3.5 Develop simulation and forecasting tools 

for dosing guidance supported by a wellcurated 

reference data set combined with 

patient specific data 


Remarks 

(May include expected 

cost/benefit, ROI, etc) 

environment for the 

practicing physician 

Enable physician to 

gauge the individual 

therapeutic response 

more accurately 

Improve quality of 

patient care and lower 

risk 

Avert potential adverse 

events (AE) and improve 

response to AE 

Personalize patient 

therapy 

2.3.6 Symptom Analyzer Aid physicians to avoid 

drugs with side effects or 

mitigate such effects by 

altering dose 

2.3.7 Medicine Selector Provide guidance to 

physicians to help 

identify the right 

medicine based on the 

patient’s condition 

2.3.8 Automate the interface to simulation 

tools so that non-expert users can 

generate routine forecasts by themselves 

2.3.9 Provide educational aids for 

understanding and using clinical 

pharmacology in routine practice 

Improve patient care 

while allowing modelers 

to focus on complex 

model development 

Improve resident training 

and promote usage by all 

CHOP practitioners 

2.4. Project Objectives 

The objective of this project is to fulfill the business requirements as listed above over several phases. 

The specific objectives targeted for phase I include: 

1. Define project scope 

2. Gather detailed requirements 

3. Define solution & technical architectures 

4. Collate and integrate necessary data from existing data stores for the two drug candidates 

5. Develop tools for creation of analysis-ready data for mining, querying and forecasting 




6. Construction of individual drug platforms/interfaces defined and built by collaboration with 

physicians and/or therapeutic area champions, clinical pharmacologists and IT specialists 

7. Deliver a functional prototype by June 2006 

2.5. Constraints 

• Any necessary science (models, algorithms, or logic) required for implementation within the tools 

are either already available or are feasible to be developed by 2Q06 

• All necessary data are already collected in an electronically useable form and made available to 

the team 

• The usefulness of the tool is dependent on the availability of comprehensive sets of patient and 

disease management data and a close fit of modeling conditions to patient conditions. As such, 

PKB will only serve as a physicians’ aid and cannot recommend patient specific treatments or 

actions 

2.6. Assumptions 

• Physician time is available as required to develop the prototype specification 

• Institutional provision will be made to test the usefulness of the system in practice 

• All access to systems, data and other interfaces are available in a timely manner 

2.7. Risks 

Project Risk 

PKB’s suggestion is viewed as an 

authoritative answer to a specific 

problem 

The perceived impact of the project 

is limited to the choice of drug 

candidates 

PKB can be perceived to be a data 

reporting solution 

PKB can be perceived as a solution 

for all disease models and 

therapeutic scenarios 

Risk Management Strategy 

Educate users that PKB is only making an educated guess 

based on historical experience and patient profile as an aid to 

the physician and cannot replace his/her recommendation 

Careful choice of the initial drug candidates for the dash 

board is very important not only for illustrating the value of 

the solution but must also provide broad exposure to a large 

number of practicing physicians 

Educate users on the distinction between reporting solutions 

and decision support systems that distill the data to 

meaningful information that can guide decision 

Educate users on the specific capabilities and limitations of 

PKB 

2.8. Impacts 

The project will have a significant impact on the following areas: 

• Improve the quality of patient care, averting or mitigating potential adverse events 

• Speed up physician research for broad based information, forecasting tools on selected 

Disease/Drug candidates 

• Improve the quality of resident training by making an accessible on-line research tool for 

exploring therapeutic options 




3. Project Description 

3.1. Scope 

The scope of the project is to demonstrate the value of combining and incorporating historical trend 

analysis with modeling & simulation approaches in extending the range of therapeutic options 

available to a physician as well as personalizing such treatment to individual patient profile, thereby 

improving the quality of patient care at CHOP. The merits of the proposed project will be 

demonstrated by, developing and making available, a functional prototype tool that will serve as a 

guide to the practicing physician. 

3.1.1. In Scope 

The initial prototype will focus on two (2) or three (3) selected drug candidates to illustrate value 

proposition as well as provide broad exposure to a large number of physicians of the potential use of 

the proposed approaches in routine practice. As part of this effort it will include the following: 

3.1.1.1.Building a comprehensive and tightly integrated dataset for the selected drugs 

3.1.1.2.Generate analysis-ready datasets for trend analysis, modeling and simulation 

3.1.1.3.Develop tools to display pictorial ‘Nomograms’ for therapeutic guidance 

3.1.1.4.Develop tools to integrate protocol information into therapeutic guidance 

3.1.1.5.Develop educational aids for fostering the principles and use of clinical pharmacology 

3.1.1.6.Integrate modeling and simulations tools for individual and population prediction 

3.1.1.7.Develop and integrate AE prediction tools for individual patient 

3.1.1.8.Deploy prototype/tool for enterprise wide physician access 

3.1.2. Out-of-Scope 

The project scope does not include the following: 

3.1.2.1.Building an enterprise wide warehouse for all institutional data 

3.1.2.2.Develop browsing tools for warehouse data 

3.1.2.3.Develop disease models, simulation tools, etc. 

3.1.2.4.Develop new scientific methods, algorithms and/or validation tools for the same 

3.1.2.5.Develop data integration or automation tools for data flow 

3.2. Milestones 

Milestone 

Target Date 

Plan Kickoff 10/07/05 

IRB Submitted 11/1/05 

Project Charter Approved 11/15/05 

Requirements complete 12/31/05 

Submit Grant application to National Library of Medicine 1/31/06 

Approved Implementation Plan 2/15/06 

Non-working Prototype 3/15/06 

Functional Prototype 6/30/06 




3.3. Deliverables 

• Non-functional application prototype – March ‘06 

• Functional prototype with a ‘dosing guidance dashboard’ complete for 2 target drugs – June ‘06 

3.4. Critical Success Factors 

• Selection of the right drug candidate with comprehensive monitoring data and in-house 

experience to validate the value proposition 

• Key choice of modeling and simulation tools to provide right balance between accuracy, stability 

and ease of use 

• Indexed access to available in-house data 

4. Estimates 

The resources and startup/operational costs for this project are listed below. 

A. Estimated Resources 

Resource 


Project Managers 

Project Administrator 

PK/PD Modelers 

Clinicians 

Programmers 

CHOP IS 

Total Hours 

Estimate 

TBD 

TBD 

TBD 

TBD 

TBD 

TBD 

TBD 

Comments 

* Estimated Resource Total * 

B. Estimated Costs 

Type of Cost Amount Cost Center 

Base Software License 

TBD 

Interface Software development 

TBD 

Hardware 

TBD 

Implementation/Training 

TBD 

Maintenance/Support (annual starting year 1) 

TBD 

Other 

TBD 

* Estimated Year 1 Total * 

* Estimated Year 2 + Total * 




* Is there a Capital Budget for Fiscal Year N Y/N 

* Is there an Operating Budget for Fiscal Year Y Y/N 

5. Project Communications and Control 

5.1. Project Management 

Mr. Narayan and Dr. Vijayakumar are the internal and external project managers for this project 

responsible for day-to-day management, conducting required meetings and ensuring the timely delivery 

of all milestones and deliverables as defined herein. In addition, they are responsible for identifying 

required resources and issues requiring management intervention and communicating them to the project 

leader. They will report regular status as defined in the communication plan for distribution to the 

project team and stakeholders. 

Please refer to Appendix ‘B’ ‘Project Roles and Responsibilities’ for additional details on project 

organization, staffing, resource requirements, and roles and responsibilities. 

5.2. Project Communications 

Project Team meetings will be held weekly for the duration of the project. This meeting will address the 

project status (activities completed, planned activities for the next period, resource issues) and identify 

the issues requiring escalation to management. Executive Steering Committee meetings will be held on a 

4-6 week basis as needed to address project status, potential risks, and issues requiring management 

intervention. Additional details regarding project communications are included in Appendix ‘A’ 

Communications Plan. 

5.3. Risk Management 

Project status meetings will actively monitor risks defined in Section 2.7 ‘Risks’ requiring immediate 

attention will be addressed based on the defined mitigation strategy. As needed, activities will be tracked 

by means of a project issue log. Additional needs for escalation will be identified on a case-by-case basis. 

5.4. Issue Management 

To better track and coordinate issues arising within the project, an issue-tracking log will be used. The 

issue-tracking log will contain a description of the issue, the author of the issue, the person assigned to 

resolve the issue, and a target date as to when the issue should be closed. 

5.5. Change Management 

Proposed scope changes will be quantified in terms of impact to project schedule, cost and resource 

usage. Multiple scenarios will be explored to understand the consequences of accepting or rejecting 

changes in scope. An escalation procedure will be followed for any major changes to scope. 




Appendix A – Project Communications Plan 

Communication/ 

Deliverable Audience Purpose/Content 

Status Meeting Project working Review current 

team 

status; identify 

Status Meeting 

Minutes 

Issues Log 

Project Plan 

Project 

Documentation 

Management 

Update 

Project working 

team 

Active 

participating 

stakeholders 

Project working 

team 

Reference; 

project archives 

Senior 

Management 

issues; plan 

Document 

current status; 

identify issues; 

plan 

Track project 

issues outside 

those captured in 

minutes or 

project plan; also 

address risk and 

change 

Define project 

tasks, milestones 

and schedule 

Detail 

deliverables 

Executive level 

project review 

Medium for 

Delivery 

Meeting/ 

conference call 

Word doc via 

email 

Excel 

Microsoft Project 

Word/Excel/Visio 

Informal 

presentation 

Frequency/ 

Timing 

Weekly 

Weekly 

Weekly 

Weekly/ 

As needed 

As needed 

4-6 weeks 




Appendix B - Project Roles and Responsibilities 

Role 


Champion/User 

Leader 


Business Analyst 

Project Manager 

Technical Project 

Leader 

Technology 

Architect/Lead 

Developer 

Developers 

Data Modeler 

Application 

Modelers 


Administrator 

Application Tester 

Responsibilities 

• Champion for the project cause 

• Provide vision and guidance to the project 

• Ensure user needs are met 

• Initiate project and communicate value proposition to key stakeholders 

• Define scope and deliverables 

• Secure funding and allocate resources 

• Gather user requirements 

• Identify current workflow/dataflow processes 

• Define testing, validation and acceptance criteria 

• Coordinate user training and deployment 

• Responsible for day-to-day management of the project 

• Conduct meetings, identify and bring issues to resolution 

• Responsible for timely delivery of the solution within budget 

• Resource planning and task allocation 

• Report status as defined in the communication plan 

• Responsible for analysis of requirements 

• Define solution architecture 

• Develop specifications for solution development 

• Works with the solution architect and IT to identify key technologies that 

are suitable for building the solution 

• Develop proof-of-concept prototypes to validate technology choice 

• Guide the developers to build the solution 

• Maintain code repository, versions and manage deployment 

• Develops and tests unit code to specification within the guidelines and 

standards established for the project 

• Analyze requirements and conceptualize the logical model 

• Develop physical tables, indexes and storage parameters 

• Responsible for creation of new PK/PD models 

• Identify the models/environment to be used for simulation 

• Validate the developed models and provide criteria for assessing the 

usefulness and relevance of the models 

• Collate and administer project documentation 

• Maintain versions and responsible for dissemination/distribution 

• Create test scripts with the technical project leader and business analyst 

• Execute test scripts and produce test report 

The Children’s Hospital of Philadelphia Page 10 of 10 9/18/2006 4:28 PM 



PROJECT DOCUMENT APPROVAL 

Sign-off Sheet 

I have read the above Charter and will abide by its terms and conditions and pledge my full commitment and 

support for the project # - Pediatric Knowledgebase 

Executive Sponsor – Peter Adamson, MD – Department of Pediatrics 

Date 

Project Leader – Jeffrey S Barrett, PhD 

Date 

Project Manager - Mahesh Narayan / Sundararajan Vijayakumar 

Date 

Project Administrator – Dimple Patel 

Date 

PK/PD Modelers – Manish Gupta / John Mondick / Dominique Paccaly 

Physician Champions – Jeffrey Skolnik / Kelly Wade 

Date 

Programmers: BITS / INTEK Partners 

Date 

Data Modelers: Bhuvana Jayaraman 

Date 

The Implementation Plan is estimated to be completed and approved by January 31, 2006. 




Revision History 

Date Version Description of Modification Author 

10/7/2005 0.1 Create Document Mahesh Narayan 

11/1/2005 0.2 Modify Document S. Vijayakumar 

11/8/2005 0.3 Incorporate team comments S. Vijayakumar & 

Mahesh Narayan 

Glossary of Terms 

Acronym 

PKB 

CPT 

PK 

PD 

Description 

Pediatric Knowledgebase 

Clinical Pharmacology & Therapeutics 

Pharmacokinetics 

Pharmacodynamics

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