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Library

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.
0.6Project Manager
Scope approval if requiredFunder, project team, head of standards
0.6Project Manager
Review project plan, scope, and Wiki structures with 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.

Stage 1 – Concept Modeling 


Metadata Developer 



Evaluate and Define concepts 

Concept Developer

Metadata Developer


Creates concept maps



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

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 ManagerStandards Development

Revise existing domains

  • New variables
  • Metadata Specs
  • Assumptions
  • Check for implications to other domains; 
  • 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;  
  • 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 ManagerReview

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
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 / Metadata Analyst 

Review

Resolve gaps or discrepancies and prepare the draft standard for the Internal Review with Metadata Analyst 

like TAUG 2.13

Project Manager


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
3.8Project Manager
Post for Public Review (Website, Wiki)*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
3.18Project Manager

GGG meeting for Publication approval


3.19Project Manager
GGG sign-off of public review comment resolutionrep.s
Stage 3c - Publication
3.20Head of Standards
Heads of Standards Approval and notification to all Heads
3.21Copy Editor
Final Copy-editing Check
3.22Project Manager
Address copy-editing comments
3.23Project Manager
Lockdown Wiki space


3.24Copy editor
Create PDFPublication
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 space

Raise a ticket to Comms to Archive

space