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Instructions

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.



AccountableMilestonefrom spreadsheetComments

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 template
I 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 plan
At 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 


Variables to be deprecated



Check all cross-references

  • Example
  • Domains (Specs, Assumptions)




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





Revise Non-domain sections

  • Reorganize section
  • Add / Delete information




Add new Non-domain section



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




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




CT Final check before IR

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




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)



Project Manager

Resolves gaps or discrepancies and prepares the draft standard for the Internal Review.




Project Manager

Conducts a project review with the Modeling Experts, as needed.




Project Manager

Alerts the Global Governance Group when the draft is nearing internal review.




GGG Lead

GGG approves the modeling before the standard may be posted for internal review.



Stage 3a - Internal Review
3.a.1Project ManagerTeam Review before GGG

3.a.2Project ManagerResolution of team review issues

3.a.3Project ManagerMaterial prepared for GGG Internal Review (IR)

3.a.4Head of Data StandardsGGG meeting for IR approval

3.a.5Project ManagerInternal Review

3.a.6Project ManagerIR comment resolution

3.a.7Copy EditorPre-public review copy editing

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

3.a.8Project ManagerPrepare for GGG Public Review (PR)

3.a.9GGG LeadGGG meeting for PR approval

3.a.10GGG LeadSign-off for PR Approval

Stage 3b - Public Review
3.b.1Software EngineerScrape and load to Stage/Prod as Draft

3.b.2Publications Team*Post for Public Review (Website, Wiki)
*This needs to be one role
3.b.3Project ManagerPublic Review (PR)

3.b.4Project ManagerPR comment resolution
this is PM but blue because it's SD/DS effort
3.b.5Project ManagerFDA review

3.b.6Project ManagerFDA comment resolution

3.b.7Software EngineerScrape and load to QA

3.b.8Project ManagerPerform UAT with Metadata Analyst
This includes identifying reviewers, etc.
3.b.9Project ManagerUAT Comment resolution with Metadata Analyst

3.b.10Project ManagerUAT Validation of fixes

3.b.11Project ManagerPub material ready for GGG

3.b.12Heads of Standards

GGG meeting for Pub approval



3.b.13Project ManagerGGG sign-off for publication (pub) approval

Stage 3c - Publication
3.c.1Head of StandardsHeads of Standards Approval

3.c.2Copy EditorFinal Copy-editing Check

3.c.3Project ManagerAddress copy-editing comments

3.c.4Project ManagerLockdown Wiki space
Raise a ticket to IT to Lockdown Wiki space
3.c.5Copy editorCreate PDF

3.c.6Project ManagerExport public review comments

3.c.7Software EngineerScrape and load to Stage/Prod 

3.c.8Project ManagerPost on Website
Raise a ticket to IT to post on Website
3.c.9Project Manager

Archive Wiki space


Raise a ticket to Comms to Archive space
3.c.10GGG 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?

3.c.11Software DeveloperScrape and load to DEV
Success confirms that there are no issues with structures
3.c.12Project ManagerPost on Website
Raise a ticket to IT to post on Website
3.c.13Project ManagerArchive Wiki Space
Raise a ticket to Comms to Archive space
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