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Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb in the Instructions column.



Accountable
MilestoneComments

Stage 0 – Scoping & Planning 

0.1Project Manager
Create project artifacts (Jira, Wiki)For TAUGs, grant proposal has been signed and project is slated to start
0.2Project Manager 
Create project plan from templateI think this will be a new action for Alana, normal for Dana except that it comes from a template now which can be added to in 0.5
0.3Project Manager
Review scope

For TAUGs, this includes review of signed off Proposal (eg. 18 months, 10 concepts)


0.4Project Manager

Create project charter Wiki page


Wiki page can contain proposal but high level details should be included on the page. 

Charter page should be from a common template so that all project charters could be exported and seen in a spreadsheet.  

Would it be possible to identify common information that both SD and DS are interested in to create template? That way projects that don't include SD would still be consistent and they'd be able to be reported along with the SD, SD/DS projects.

0..5Project Manager
Update project planAt this time additional items are added to Jira plan that was created by the template.
0.6
Metadata Analyst
Project Manager
Scope approval if requiredFunder, project team, head of standards
0.6Project Manager
Review project plan, scope, and Wiki structures with
Project Manager
 Metadata Analyst

PM and Metadata Analysts meet at start of the project to make sure both departments aligned, however, PM and Metadata Analysts should continue to review during Stage 1 & 2 and should plan meeting cadence at this time

.0.7Project ManagerSubmit scope to GGG for review

Part of template but if not applicable, canceled when project plan created.

Known scope gets approved by GGG.  

However, in some cases new domains and variables go to GGG as they come up now through development.

0.8GGG LeadGGG approves scopePart of template but if not applicable, canceled when project plan created

.

Where is the formal project kickoff with the team where the charter/scope, wiki, and team processes reviewed?

Stage 1 – Concept Modeling 

Project Team Lead

Reviews QRS and initiate process for collecting the required copyright permissions.

QRS Representative

Expands initial gap analysis, identify needed questionnaires and acquire permissions.

Expands the initial gap analysis

Identifies questionnaires that are needed

Initiates the process for acquiring permissions. 

QRS Representative / Clinical Expert

Review the list of instruments and identify those that need development.

Metadata Developer

Model Concepts

Reviews questionnaires and scales.

Initiates the process for collecting the required copyright permissions.


Metadata Developer 

Define concepts that have not been addressed in current CDISC standards



Evaluate and Define concepts 

Concept Developer
Clinical Expert

Evaluate new and different research concepts to ensure the data are clearly understood

Metadata Developer

Refine Deliverable Plan


Metadata Developer


Creates concept maps

Foundational Standard Expert 

Work with the Project Team to address areas not covered by the current foundational standard IG.



Clinical Expert / SME


Review and confirm core concepts are complete, adequate, and appropriate


Ensures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing.

Project Team Lead


Refine concept maps and list of concepts as necessary



Project Manager

Submit all examples to GGG

Project Team Lead

Refine examples based on GGG feedback

GGG  Lead

GGG approves the modeling 

GGG approves the modeling before the team can move to stage 2Project Manager

Update the project plan and charter

Notifies all parties involved.

Performs CDISC project review.


Metadata Developer


Refine Deliverable Plan


Stage 2 – Development of Draft Standards 

Project Manager
Variables to be deprecatedProject Manager

Check all cross-references

  • Example
  • Domains (Specs, Assumptions)
Project Manager

Revise appendices (team members, revision history, etc.)

Project Manager

Revise Non-domain sections

  • Reorganize section
  • Add / Delete information
Project ManagerAdd new Non-domain sectionProject Manager
Standards Development

Revise

Revise

existing domains

  • New variables
  • Metadata Specs
  • Assumptions
  • Check for implications to other domains;
request tasks not already in plan
  •  
  • Examples
  • Include CT early and often
  • Include Data Science early and often

Project ManagerStandards Development

Create New Domains

  • New variables
  • Metadata Specs
  • Assumptions
  • Check for implications to other domains;
request tasks not already in plan
  •   
  • Examples
  • Include CT early and often
  • Include Data Science early and often

Project ManagerStandards Development

Revise Non-domain sections

  • Reorganize section
  • Add / Delete information

Project ManagerStandards DevelopmentAdd new Non-domain sections

Project ManagerReview

Check all cross-references

  • Example
  • Domains (Specs, Assumptions)

Project ManagerReview

Revise appendices (team members, revision history, etc.)



Project ManagerReviewEvaluate variables to be deprecated

Project ManagerReview

CT Final check before IR

  • Confirm all new domains have CT
  • Confirm all domain updates have updated CT
  • Confirm all examples have current CT

Project Manager
Data Sciences Checks Before IR
Review

Work with Data Science to prepare for IR

  • Data Science check before IR
  • Data Sciences - Scrape and load into development (update pipelines)
  • Resolve gaps or discrepancies and prepare the draft standard for IR with metadata analyst
  • Review document for data sciences needs

  • Create metadata checks

  • human check visually in Wiki that all looks good for Data Sciences and the CDISC Library

  • Scrape and load into development (update pipelines)

like TAUG 2.12

Software Engineer

Scrape and load into development (update pipelines)

This was a sub-bullet in Dana's "Data Sciences Checks Before IR" milestone, but milestones for DS shouldn't be sub-bullets

Project Manager


Project Manager

Resolve gaps or discrepancies and prepare the draft standard for the Internal Review.

like TAUG 2.13

Project Manager

Final review with Metadata Analyst 

Conduct a project review with the Modeling Experts (as needed)

Material prepared for GGG Internal Review (IR)



Project Manager
Schedule GGG reviewAlert the Global Governance Group when the draft is near internal review.

GGG Lead
GGG meeting for IR approvalGGG approves the modeling before the standard may be posted for internal review.
Stage 3a - Internal Review
3.1Project Manager
Internal Review
3.2Project Manager
IR comment resolution
3.3Copy Editor
Pre-public review copy editing

This needs to start during IR and Questions / Comments need to be entered into Jira.

3.4Project Manager
Prepare

Material prepared for GGG Public Review (PR)
3.5Project Manager
Schedule GGG meeting for PR approval

Project Manager
GGG meeting for PR approval
3.6GGG Lead
Sign-off for PR Approval
Stage 3b - Public Review

Project Manager
Update metadata staging
3.7Software Engineer
Scrape and load to Stage/Prod as Draft
3.8
Publications Team*
Project Manager
Post for Public Review (Website, Wiki)*
This needs to be one role
done by ticket to Comms
3.9Project Manager
Public Review (PR)Make necessary updates (Erin puts in tickets to make updates)
3.10Project Manager
PR comment resolutionthis is PM but blue because it's SD/DS effort
3.11Project Manager
FDA review
3.12Project Manager
FDA comment resolution

Project Manager
Update metadata staging
3.13Software Engineer
Scrape and load to QA
3.14Project Manager
Perform UAT with Metadata AnalystThis includes identifying reviewers, etc.
3.15Project Manager
UAT Comment resolution with Metadata Analyst
3.16Project Manager
UAT Validation of fixes
3.17Project Manager
Pub material ready for GGG
3.18
Heads of Standards
Project Manager

GGG meeting for

Pub

Publication approval


3.19Project Manager
GGG sign-off
for publication (pub) approval
of public review comment resolutionrep.s
Stage 3c - Publication
3.20Head of Standards
Heads of Standards Approval
This appears to be a duplicate of GGG approval, Heads are on GGG, is this step needed?
and notification to all Heads
3.21Copy Editor
Final Copy-editing Check
Why is this not done after 3.12, 3.13, or 3.16?  GGG approval for publication should not have any changes made thereafter.

3.22Project Manager
Address copy-editing comments
This would not be needed if done after 3.16

3.23Project Manager
Lockdown Wiki space

Raise a ticket to IT to Lockdown Wiki space

This should be immediately after GGG approval


3.24Copy editor
Create
PDF
Publication
3.25Project Manager
Export public review comments

Project Manager
Update metadata staging
3.26Software Engineer
Scrape and load to Stage/Prod 
3.27Project Manager
Post on WebsiteRaise a ticket to IT to post on Website
3.28Project Manager

Archive Wiki

spaceRaise a ticket to Comms to Archive

space