clinical informatics and data management unit · web viewstudy project manager: (client nominee)...

14
CLINICAL INFORMATICS AND DATA MANAGEMENT UNIT DEPARTMENT OF EPIDEMIOLOGY AND PREVENTIVE MEDICINE MONASH UNIVERSITY {ENTER PROJECT NAME} PROJECT BRIEF V6.1

Upload: others

Post on 31-Mar-2021

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

CLINICAL INFORMATICS AND DATA MANAGEMENT UNIT

DEPARTMENT OF EPIDEMIOLOGY AND PREVENTIVE MEDICINE

MONASH UNIVERSITY

{ENTER PROJECT NAME}

PROJECT BRIEF V6.1

Page 2: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

1. DOCUMENT INFORMATION

Project Name: Prepared By: Document Version No:

Title: Document Version Date:

Reviewed By: Review Date:

1.1 DOCUMENT VERSION HISTORY

VersionNumber

VersionDate Revised By Description Filename

Document Created

1.2 APPROVALS

This document requires the following approvals. Signed approval forms should be filed appropriately in the project filing system

Name Title Action* Date Version

* Action Types: Approve, Review, Inform, File, Action Required, Attend Meeting, Other (please specify)

1.3 DISTRIBUTION LIST

Name Title OrganisationDavid Morrison System Development Manager Monash University

CIDMU_Project Brief V6 Page 1 of 11 Last Updated: 22/3/2013

Page 3: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

2. TABLE OF CONTENTS

1. DOCUMENT INFORMATION................................................................................................................... 1

1.1 DOCUMENT VERSION HISTORY.......................................................................................................................11.2 APPROVALS.................................................................................................................................................11.3 DISTRIBUTION LIST.......................................................................................................................................1

2. TABLE OF CONTENTS............................................................................................................................. 2

3. INTRODUCTION..................................................................................................................................... 3

3.1 PURPOSE....................................................................................................................................................33.2 INTENDED AUDIENCE....................................................................................................................................3

4. PROJECT DEFINITION............................................................................................................................. 3

4.1 BACKGROUND..............................................................................................................................................34.2 PROJECT OBJECTIVES.....................................................................................................................................34.3 DATA COLLECTION........................................................................................................................................34.4 SYSTEM BUILD.............................................................................................................................................44.5 SYSTEM FUNCTIONALITY.................................................................................................................................54.6 INTEGRATION...............................................................................................................................................54.7 MIGRATION.................................................................................................................................................54.8 AVAILABILITY...............................................................................................................................................54.9 CAPACITY....................................................................................................................................................54.10 SUPPORT..................................................................................................................................................5

5. BUSINESS CASE...................................................................................................................................... 6

5.1 EXECUTIVE SUMMARY...................................................................................................................................65.2 BUSINESS JUSTIFICATION................................................................................................................................65.3 PROJECT OUTCOMES.....................................................................................................................................65.4 PROJECT RISK..............................................................................................................................................65.5 CONSTRAINTS..............................................................................................................................................65.6 TIME..........................................................................................................................................................65.7 BUDGET.....................................................................................................................................................75.8 INTERESTED PARTIES.....................................................................................................................................7

6. PROJECT MANAGEMENT TEAM STRUCTURE..........................................................................................8

6.1 ROLE DESCRIPTIONS......................................................................................................................................8EXECUTIVE............................................................................................................................................................8SENIOR SUPPLIER...................................................................................................................................................8STUDY PROJECT MANAGER......................................................................................................................................8BUSINESS ANALYST.................................................................................................................................................8SCRUMMASTER.....................................................................................................................................................8CHAMPION USER....................................................................................................................................................86.2 ROLES AND RESPONSIBILITIES..........................................................................................................................9

8. REFERENCES........................................................................................................................................ 10

CIDMU_Project Brief V6 Page 2 of 11 Last Updated: 22/3/2013

Page 4: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

3. INTRODUCTION

3.1 PURPOSE

The purpose of this document is to enable CIDMU to provide project cost estimation.

3.2 INTENDED AUDIENCE

The audience of this document is CIDMU Development Manager, and CIDMU Technical Lead.

4. PROJECT DEFINITION

4.1 BACKGROUND

CLIENT to COMPLETE - (Please provide a short description of the project)

4.2 PROJECT OBJECTIVES

CLIENT TO COMPLETE – What do you want the system to do?

EG: To develop a web based data capture and reporting systems that enables…

4.3 DATA COLLECTION

CLIENT TO COMPLETE –

a) Collection of data from XXX sites?

b) Collection of data for XXX participants?

c) Collection of data for XX visits per participant?

d) Collection of data for XXX duration?

CIDMU_Project Brief V6 Page 3 of 11 Last Updated: 22/3/2013

Page 5: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

e) If an RCT, expected recruitment timeframe?

f) What is the expected lifespan of the system?

g) Collection of data on XX forms (e.g. baseline, follow up adverse event). Are any of the forms repetitive (e.g. daily)?

4.4 SYSTEM BUILD

a) Is the proposed database an entirely new system or is it a version of an existing system?

b) If an existing system is available, how different is the proposed system from the existing system?

c) Is there a need to import data from another service? What frequency is the data import expected?

d) How much data do you intend to collect using the proposed database (number of records and number of data elements)?

e) If an RCT, is the system expected to handle randomisation?

f) Are there any reporting requirements? E.g. management reports and clinical reports

g) Any other special requirements?

CIDMU_Project Brief V6 Page 4 of 11 Last Updated: 22/3/2013

Page 6: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

4.5 SYSTEM FUNCTIONALITY

CLIENT TO COMPLETE – What are the functionalities you are expecting from this system – e.g.

Data capture from multiple sites On-line error checking Centralised reporting

4.6 INTEGRATION

CLIENT TO COMPLETE - Are there any data feeds or interfaces with other systems to be developed?

4.7 MIGRATION

CLIENT TO COMPLETE – Does any existing data require to be migrated to the new system? If so, is a sample extract available, database schema and/or data dictionary?

4.8 AVAILABILITY

CLIENT TO COMPLETE – When is the service expected to be available? Business Hours, Weekends?

4.9 CAPACITY

CLIENT TO COMPLETE – How many users are expected to connect? How many would connect at a time?

4.10 SUPPORT

CLIENT TO COMPLETE – What after development support is required?

CIDMU_Project Brief V6 Page 5 of 11 Last Updated: 22/3/2013

Page 7: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

5. BUSINESS CASE

5.1 EXECUTIVE SUMMARY

CLIENT TO COMPLETE – Please provide a more detailed description and landscape of the project including project problems or issues.

5.2 BUSINESS JUSTIFICATION

CLIENT TO COMPLETE – What are the purpose of this project? What are you trying to achieve?

5.3 PROJECT OUTCOMES

CLIENT TO COMPLETE – What are the benefits you are expecting from this project?

5.4 PROJECT RISK

CLIENT TO COMPLETE - (Identify risks associated with development, delay, stakeholders etc.)

5.5 CONSTRAINTS

CLIENT TO COMPLETE - Are there any constraints to the project that we need to be aware of? e.g. Proposed project time lines i.e. when do you want the system to be available by? Budget i.e. is funding to be provided by a grant application, the outcome of which is as yet, unknown?

5.6 TIME

CLIENT TO COMPLETE – Do you have a deadline to meet or preferred time frame?

CIDMU_Project Brief V6 Page 6 of 11 Last Updated: 22/3/2013

Page 8: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

5.7 BUDGET

CLIENT TO COMPLETE –

a) Have you secured a funding? If so, please state what type (NHMRC / Industry)? What budget have you allocated for data management?

b) Is this proposal related to a future grant? If so, what type?

5.8 INTERESTED PARTIES

CLIENT TO COMPLETE – Who else is involved in this project that may want to have a say – other stakeholders?

CIDMU_Project Brief V6 Page 7 of 11 Last Updated: 22/3/2013

Page 9: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

6. PROJECT MANAGEMENT TEAM STRUCTURE

6.1 ROLE DESCRIPTIONS

EXECUTIVE

(CLIENT TO COMPLETE - Name the key stakeholders that will sign off on the requirements and approval budget expenditure)

SENIOR SUPPLIER

(This will be the CIDMU Systems Development Manager)

STUDY PROJECT MANAGER

(CLIENT to complete - This will be the Study Project Manager that will be heavily involved in the requirements specifications, application development and user testing)

BUSINESS ANALYST

(This will be the business analyst for the project from CIDMU)

SCRUMMASTER

(This will be the software development team leader for the project from CIDMU)

CIDMU_Project Brief V6 Page 8 of 11 Last Updated: 22/3/2013

Executive:Chris Reid (CIDMU) + Principle Investigator

Senior Supplier:David Morrison

(CIDMU)

Study Project Manager:

(CLIENT Nominee)

Business Analyst: (CIDMU Nominee)

Champion User: (CLIENT Nominee)

Project ScrumMaster: (CIDMU Nominee)

Page 10: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

CHAMPION USER

(CLIENT to complete - This will be the main user of the system, that may be heavily involved in the requirements specifications, application development and user testing)

6.2 ROLES AND RESPONSIBILITIES

Executive

Approve the Project including budget

Approve the System Requirements Specification

Confirm acceptance of the projects product

Provide executive support to the project team

Senior Supplier

Verify the System Requirements Specification

Provide resources to undertake project activities

Provide technical expertise and assistance

Oversee project progress

Study Project Manager

Participate in all sprint planning and review meetings

Prepare the System Requirements Specification with Business Analyst

Manage the priorities of the project

Collate system improvements and change requests

Provide acceptance of the project product

Business Analyst

Participate in all workshops, sprint planning and review meetings

Prepare the System Requirements Specification

Manage the Initiation phase of project

Collate system requirements and User Acceptance Tests

Provide systems design documentation

ScrumMaster

Participate in all sprint planning and review meetings

Assist with the System Requirements Specification with Business Analyst

Manage the priorities of the software development team

Manage the Scrum development process

Provide project progress reporting

Champion User

Assist with the User Acceptance Test

Assist with product Usability Test

Provide acceptance of the project product

7.

CIDMU_Project Brief V6 Page 9 of 11 Last Updated: 22/3/2013

Page 11: Clinical Informatics and Data Management Unit · Web viewStudy Project Manager: (CLIENT Nominee) Project ScrumMaster: (CIDMU Nominee) Executive. (CLIENT TO COMPLETE - Name the key

8. REFERENCES

CLIENT TO SUPPLY Data Dictionary Project Protocol Any other relevant documentation

CIDMU_Project Brief V6 Page 10 of 11 Last Updated: 22/3/2013