**\<Insert Project ID\>**

**eDCI message development**

**\< Project Classification\>**

**Project Charter**

**10 October 2005**

**Version 1.0**

**TABLE OF CONTENTS**

[1.0 Revision History 1](#revision-history)

[2.0 Project Overview / Description 1](#project-overview-description)

[2.1 Strategic Fit 1](#strategic-fit)

[2.1.1 HL7 Strategic Imperative 1](#hl7-strategic-imperative)

[2.1.2 The mandate of the project is to:
1](#the-mandate-of-the-project-is-to)

[2.2 Completion and Success Criteria:
1](#completion-and-success-criteria)

[2.2.1 We have reached completion when:
1](#we-have-reached-completion-when)

[2.2.2 We have achieved success when: 1](#we-have-achieved-success-when)

[2.2.3 Who gets to vote on completion and success:
1](#who-gets-to-vote-on-completion-and-success)

[3.0 Project Scope 1](#project-scope)

[3.1 Scope Inclusions 1](#scope-inclusions)

[3.2 Scope Exclusions 1](#scope-exclusions)

[4.0 Project Goals, Objectives and Deliverables
1](#project-goals-objectives-and-deliverables)

[5.0 Project Stakeholders, Participants and Resources
1](#project-stakeholders-participants-and-resources)

[5.1 Leadership Team 1](#leadership-team)

[5.2 Active Participants & Required Resources
1](#active-participants-required-resources)

[6.0 Project Assumptions and Constraints
1](#project-assumptions-and-constraints)

[6.1 Project Assumptions are: 1](#project-assumptions-are)

[6.2 Project Constraints are: 1](#project-constraints-are)

[7.0 Project Risks 1](#project-risks)

[7.1 Project Risks 1](#project-risks-1)

[8.0 Preliminary Project Plan 1](#preliminary-project-plan)

[8.1 Project Plan/Schedule 1](#project-planschedule)

[9.0 Inter-Project Dependencies 1](#inter-project-dependencies)

[10.0 Charter Acceptance/ Approvals 1](#charter-acceptance-approvals)

[11.0 Appendices 1](#appendices)

[11.1 Appendix A -- Client Engagement 1](#appendix-a-client-engagement)

[11.2 Appendix B -- Project Controls 1](#appendix-b-project-controls)

  -------------------- --------------------------------------------------
  \<Project Id, Name,  
  Classification \>    

  Project Sponsor:     RCRIM

  Responsible Party:   RCRIM

  Technical Committee: RCRIM

  Project Leader /     Don Kacher, Oracle Corporation
  Manager:             

  HL7 Facilitator:     Mead Walker
  -------------------- --------------------------------------------------

# Revision History

+-------+---------+--------------------------+------------------------+
| #     |         |                          |                        |
| ##### |         |                          |                        |
|  File |         |                          |                        |
|  Name |         |                          |                        |
|  {#fi |         |                          |                        |
| le-na |         |                          |                        |
| me .u |         |                          |                        |
| nnumb |         |                          |                        |
| ered} |         |                          |                        |
+-------+---------+--------------------------+------------------------+
| ##    | *       | **Author**               | **Description**        |
| ####  | *Date** |                          |                        |
| Versi |         |                          |                        |
| on {# |         |                          |                        |
| versi |         |                          |                        |
| on .u |         |                          |                        |
| nnumb |         |                          |                        |
| ered} |         |                          |                        |
+-------+---------+--------------------------+------------------------+
| **    | **10-O  | **Don Kacher**           | **Created**            |
| 1.0** | CT-05** |                          |                        |
+-------+---------+--------------------------+------------------------+
|       |         |                          |                        |
+-------+---------+--------------------------+------------------------+

# Project Overview / Description

## Strategic Fit

This message specification fulfills part of RCRIMs objectives, in
supporting the transmission of definitions and data concerning the
conduct of clinical trials.

### HL7 Strategic Imperative

RCRIMs mission is developing standards to improve or enhance information
management during research and regulatory evaluation of the safety and
efficacy of therapeutic products or procedures worldwide.

The messages developed in this project will contribute to this mission
by providing standards by which the definition of a data collection
instrument (a form) can be sent between applications, and by which data
collected according to the form definition can be transmitted between
application.

### The mandate of the project is to:

Create V3 messages needed to:

1\) transmit data arising from protocol-driven research

2\) transmit definitions of instruments for collecting such data

Topic 2 necessarily precedes topic 1.

The instrument definition message will presume the existence of a way of
communicating the definitions of vocabularies used in the instruments.
This project will address resolving these references in three ways:

1\. It will investigate and specify ways to use existing mechanisms to
resolve these references

2\. It will define a mechanism to transmit such definitions, when
needed, within the definition message

3\. It will investigate planned vocabulary-distribution services (CTS),
and specify how they can be used with the messages.

## Completion and Success Criteria:

### We have reached [completion]{.underline} when:

Messages for both data and definition have been successfully balloted,
and references to vocabularies needed by Instruments can be successfully
resolved as outlined above.

### We have achieved success when:

### [Who]{.underline} gets to vote on completion and success?

> \< Name and role of the Key Stakeholders who decide whether the
> completion criteria have been satisfied and whether success has been
> achieved, i.e. the Key Success Indicators have been satisfied. \>

# Project Scope

## Scope Inclusions

> The scope of this project includes:

## Scope Exclusions

> The scope of this project does not include:

# Project Goals, Objectives and Deliverables

Goals: Describe the purpose of this project in terms of its goals - what
it hopes to achieve, and what business problems or opportunities it
addresses.

Objectives: For each goal, describe the project objectives that directly
support that goal.

Deliverables: Any measurable, tangible, verifiable outcomes, results, or
items that must be produced to complete a project

  ----------------- ----------------- ------------------ --------------------
  **Goals**         **Objectives**    **Deliverables**   **Measure of
                                                         Deliverable
                                                         Completion**

  **Goal 1**        **Objective A**   Deliverable 1      

                                      Deliverable 2      

                                      Deliverable 3      

                    **Objective B**   Deliverable 4      

                                      Deliverable 5      

                                      Deliverable 6      

                    **Objective C**   Deliverable 7      

                                      Deliverable 8      

                                      Deliverable 9      

                                      Deliverable 10     

                                      Deliverable 11     

                                      Deliverable 12     

  **Goal 2**        **Objective D**   Deliverable 13     

                                      Deliverable 14     

                                      Deliverable 15     

  **Goal 3**        **Objective E**   Deliverable 16     

                                      Deliverable 17     

                                      Deliverable 18     
  ----------------- ----------------- ------------------ --------------------

#  Project Stakeholders, Participants and Resources

## Leadership Team

Project Sponsor --

Responsible Party -

Technical Committee --

HL7 Facilitator --

Project Leader / Manager --

Beneficiaries --

Project Steering Committee --

The Project Steering Committee consists of the following members:

  ----------------------------------- -----------------------------------
  **Name**                            **Role**

                                      

                                      

                                      

                                      

                                      
  ----------------------------------- -----------------------------------

## Active Participants & Required Resources

  -------------------- ------------------------- ------------------------
  Team Member          **Role**                  **Focus Area**

                                                 

                                                 
  -------------------- ------------------------- ------------------------

# Project Assumptions and Constraints

## Project Assumptions are:

## Project Constraints are:

# Project Risks 

## Project Risks

+--------------+---------+---------+-------------+----------+--------+
| **Risk       | **Prob  | **S     | **Risk      | **Con    | *      |
| Factor       | ability | everity | Strategy    | tingency | *Antic |
| D            | of      | of      | /Mitigation | Action** | ipated |
| escription** | Occ     | Impact  | Plan**      |          | Start  |
|              | urrence | (H      |             |          | -- End |
|              | (H      | /M/L)** |             |          | Date** |
|              | /M/L)** |         |             |          |        |
+==============+=========+=========+=============+==========+========+
| Describe the |         |         | Describe    | Describe | Start  |
| risk factor  |         |         | the         | the      | when?  |
|              |         |         | strategy to | action   |        |
|              |         |         | remove or   | to be    | End    |
|              |         |         | reduce/     | taken if | when?  |
|              |         |         | mitigate    | the risk |        |
|              |         |         | the risk.   | mater    |        |
|              |         |         |             | ializes. |        |
+--------------+---------+---------+-------------+----------+--------+
|              |         |         |             |          |        |
+--------------+---------+---------+-------------+----------+--------+
|              |         |         |             |          |        |
+--------------+---------+---------+-------------+----------+--------+
|              |         |         |             |          |        |
+--------------+---------+---------+-------------+----------+--------+

# Preliminary Project Plan 

A project schedule is to be developed to identify and manage all project
related activities utilizing the Project Team's tool of choice, e.g. MS
Project. When developing the project schedule, ensure that all
activities in all project phases are identified

## Project Plan/Schedule

  -------------- -------------------------------------- ----------------- --------- --------
  **Phase, Major                                        **Responsible**   **Start   **End
  Deliverable,                                                            Date**    Date**
  Activity or                                                                       
  Milestone**                                                                       

  **Project                                                                         
  Initiation**                                                                      

  1\.                                                                               

  2\.                                                                               

  3\.                                                                               
  -------------- -------------------------------------- ----------------- --------- --------

# Inter-Project Dependencies

##  {#section .unnumbered}

Inputs Required

\< What deliverables are required from other areas or projects\>

  -------------------------- -------------------------- ------------------
  **Area or Predecessor      **Deliverables Needed as   **Date Required**
  Project**                  Input**                    

                                                        

                                                        

                                                        
  -------------------------- -------------------------- ------------------

Outputs to be supplied

\< What deliverables does this project need to supply to other areas or
projects\>

  -------------------------- -------------------------- ------------------
  **Area or Successor        **Deliverables Supplied to **Date Required**
  Project**                  Successor**                

                                                        

                                                        

                                                        
  -------------------------- -------------------------- ------------------

# Charter Acceptance/ Approvals

The following approvals indicate acceptance of the project charter.

+-------------+-------------+-------------+-------------+-------------+
| **Date**    | **Status**  | **Change    | **Approval  | **Reference |
|             |             | Approved**  | Body**      | to          |
|             |             |             |             | Decision**  |
+-------------+-------------+-------------+-------------+-------------+
| ###  {#     | ###  {#     | ###  {#     | ###  {#     | ###  {#     |
| section-1 . | section-2 . | section-3 . | section-4 . | section-5 . |
| unnumbered} | unnumbered} | unnumbered} | unnumbered} | unnumbered} |
+-------------+-------------+-------------+-------------+-------------+
| ###  {#     | ###  {#     | ###  {#     | ###  {#     | ###  {#s    |
| section-6 . | section-7 . | section-8 . | section-9 . | ection-10 . |
| unnumbered} | unnumbered} | unnumbered} | unnumbered} | unnumbered} |
+-------------+-------------+-------------+-------------+-------------+

# Appendices

## Appendix A -- Client Engagement 

**Project Charter**

This Project Charter identifies the project's deliverables, timing, and
scope. It also includes specific reference to the project's governance
and project benefits.

**Customer Commitments**

We need your commitment to the following through your continued support
and championing of this initiative throughout HL7;

-   The current scope outlined in the charter will be observed, and that
    changes to scope will be managed through the appropriate change
    control processes established jointly by the project and steering
    teams

-   The issues escalation and resolution processes established jointly
    by the project team and the steering team will be followed by all
    members

-   Agreement on project governance roles with clear delineation of
    accountabilities between the project team and your role in steering
    direction of the initiative.

-   Business requirements, recommendations and agreed solutions

-   Provide access to required information and resources that may be
    outside the formal assignment to the initiative

-   Project schedule and resource plan (people and funding)

-   Agreement to the appropriate project objectives and performance
    indicators for measurement of project success

-   Establishment of the appropriate accountability for jointly creating
    and signing project acceptance documents

## Appendix B -- Project Controls 

### Project schedule (high level work plan) 

A detailed project schedule identifying the prime, start and finish and
durations of project deliverables will be developed and managed
throughout the life of the project. This plan will be available to all
project team members. The plan will include any assumptions used to
estimate the project effort and approach. Status and variance on each
identified activity will form the basis of status reporting by the
assigned resource.

### Project status reporting 

Project status will be provided; the regularity of the reporting will be
determined by the requirements of Responsible Party and the project
type.

### Project change management 

All change requests will formally documented and managed through the
Change Management processes and approvals.

As change requests are submitted, they will be assigned for assessment
and impacts, after which it will be determined if the change request is
approved or not. Changes to the scope, schedule, budget, resources, and
risk of the project caused by an approved change request will be
documented, logged and communicated to the project team and Steering
Team. Rejected change requests will be returned to the originator with
the rationale for rejecting the change request.

### Project Issue Management 

All issues identified that may impact the successful outcome of this
project must be submitted immediately to the Project Leader / Manager.
All issues will be formally documented and logged in a project issue log
that will be managed throughout the project lifecycle. The Project
Leader / Manager will review these to determine the potential project
impacts and whether the issue will be escalated for resolution. As
issues are identified, they will be assigned to the appropriate
individual or group for resolution in the requested specified timeframe.

As issues are resolved, they will be closed. Before the project can be
formally closed, all open issues must be addressed and resolved.

Identify in what form issues are to be reported, where and for how long
they will be stored, and who will have what access to them.