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AccountableMilestoneComments

Stage 0 – Scoping & Planning 

0.1Project ManagerCreate 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 ManagerReview 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 ManagerUpdate project planAt this time additional items are added to Jira plan that was created by the template.
0.6Metadata AnalystReview project plan, scope, and Wiki structures with Project Manager

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 scope

Part 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.

Reviews questionnaires and scales.

Initiates the 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



Metadata Developer 


Define concepts that have not been addressed in current CDISC standards

Concept Developer

Clinical Expert

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



Metadata Developer

Creates concept maps



Foundational Standard Expert 

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



Metadata Developer

Refine Deliverable Plan



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 2

Project Manager

Update the project plan and charter

Notifies all parties involved.

Performs CDISC project review.

Stage 2 – Development of Draft Standards 

Project ManagerVariables to be deprecated

Project 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 section

Project Manager

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 Manager

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 Manager

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 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

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)

Project Manager

Material prepared for GGG Internal Review (IR)



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

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

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

3.4Project ManagerPrepare for GGG Public Review (PR)
3.5Project ManagerSchedule GGG meeting for PR approval
3.6GGG LeadSign-off for PR Approval
Stage 3b - Public Review
3.7Software EngineerScrape and load to Stage/Prod as Draft
3.8Publications Team*Post for Public Review (Website, Wiki)*This needs to be one role
3.9Project ManagerPublic Review (PR)
3.10Project ManagerPR comment resolutionthis is PM but blue because it's SD/DS effort
3.11Project ManagerFDA review
3.12Project ManagerFDA comment resolution
3.13Software EngineerScrape and load to QA
3.14Project ManagerPerform UAT with Metadata AnalystThis includes identifying reviewers, etc.
3.15Project ManagerUAT Comment resolution with Metadata Analyst
3.16Project ManagerUAT Validation of fixes
3.17Project ManagerPub material ready for GGG
3.18Heads of Standards

GGG meeting for Pub approval


3.19Project ManagerGGG sign-off for publication (pub) approval
Stage 3c - Publication
3.20Head of StandardsHeads of Standards ApprovalThis appears to be a duplicate of GGG approval, Heads are on GGG, is this step needed?
3.21Copy EditorFinal Copy-editing CheckWhy 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 ManagerAddress copy-editing commentsThis would not be needed if done after 3.16
3.23Project ManagerLockdown Wiki space

Raise a ticket to IT to Lockdown Wiki space

This should be immediately after GGG approval

3.24Copy editorCreate PDF
3.25Project ManagerExport public review comments
3.26Software EngineerScrape and load to Stage/Prod 
3.27Project ManagerPost on WebsiteRaise a ticket to IT to post on Website
3.28Project Manager

Archive Wiki space

Raise a ticket to Comms to Archive space