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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
Milestone
from spreadsheet
Comments

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.

Stage 1 – Concept Modeling 

Project Team Lead

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 QRS and initiate process for collecting the required copyright permissions.

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 2



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 

Metadata Developer

Evaluate the templates or spreadsheets needed for the project and create any additional templates required

Metadata Developer / SDTM Expert

Determines what SDTMIG examples are needed for the standard.

Metadata Developer / CDASH Representative

Determines what CDASH examples are needed for the TA User Guide.

TA Statistical Programmer

ADaM Expert

Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide. 

Metadata Developer

Builds on the initial gap analysis to determine if new metadata needs to be developed.

Metadata Developer

Develops metadata and examples.

Project Team Lead

Analyze specific content needed and restructure metadata tables

Examine concepts and consider what specific content is needed as part of the final standards product.Metadata Developer

Creates sample data for key concepts

Creates sample data to improve understanding of all key concepts

Technical Writer

Metadata Developers and Concept Modelers

Begins to build the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers


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
  • 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


Project Manager


Material prepared for GGG Internal Review (IR)



Project Manager
Schedule GGG reviewAlert

Clinical TA Expert / Medical Writer

Create relevant sections of the TA User Guide, update label in IG, and review examples to ensure clinical accuracy and plausibility.

Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility.

Concept Developer

Copies the template sheet to a new sheet

Fills in the concept-level metadata

Deletes any concept variable rows that are not relevant for the concept, populates or modifies Controlled Terminology and SDTM variable information as needed

Adds relevant information about associations with other concepts

Identifies required Controlled terminology

Project Team LeadDomain long name alignmentProject Team Lead

New QX domain

Project Team LeadNew DC domain (draft name, MSI)Project Team LeadNew GI domain 

TA Team Lead

Drafts a Therapeutic Area Specification in collaboration with the FDA to show the different versions of the SDTM and how they relate to domains and variables contained in TA User Guides. 

Project Team LeadRevise BE, BS, and RELSPECProject Team LeadRevise DV domainProject Team LeadRevise MI domainProject Team LeadNew variablesProject Team LeadDeprecation of existing variablesProject Team LeadIncorporate CDISC glossary text references into the SDTMIGProject Team LeadDecision treesProject Team LeadSuppqual -> NSVProject Team LeadACTARMProject Team LeadRWE/RWDProject Team LeadConformance - legacy review (e.g., should -> must)Project Team LeadIncorporate SDTMIG-AP

Project Manager

Refers to the comments received from the Check of Concepts and ensures issues were resolved appropriately.

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
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
.a
.1Project Manager
Team

Internal Review
before GGG

3
.a
.2
Project ManagerResolution of team review issues3.a.3Project ManagerMaterial prepared for GGG Internal Review (IR)3.a.43.a.5Project ManagerInternal Review3.a.6
Head of Data StandardsGGG meeting for IR approval
Project Manager
IR comment resolution
3.
a.7
3Copy Editor
Pre-public review copy editing

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

3.
a.8
4Project Manager
Prepare

Material prepared for GGG Public Review (PR)
3.
a.9GGG Lead
5Project Manager
Schedule GGG meeting for PR approval

Project Manager
GGG meeting for PR approval
3.
a.10
6GGG Lead
Sign-off for PR Approval
Stage 3b - Public Review

Project Manager
Update metadata staging
3.
b.1
7Software Engineer
Scrape and load to Stage/Prod as Draft
3.
b.2Publications Team*
8Project Manager
Post for Public Review (Website, Wiki)*
This needs to be one role
done by ticket to Comms
3.
b.3
9Project Manager
Public Review (PR)Make necessary updates (Erin puts in tickets to make updates)
3.
b.4
10Project Manager
PR comment resolutionthis is PM but blue because it's SD/DS effort
3.
b.5
11Project Manager
FDA review
3.
b.6
12Project Manager
FDA comment resolution

Project Manager
Update metadata staging
3.
b.7
13Software Engineer
Scrape and load to QA
3.
b.8
14Project Manager
Perform UAT with Metadata AnalystThis includes identifying reviewers, etc.
3.
b.9
15Project Manager
UAT Comment resolution with Metadata Analyst
3.
b.10
16Project Manager
UAT Validation of fixes
3.
b.11
17Project Manager
Pub material ready for GGG
3.
b.12Heads of Standards
18Project Manager

GGG meeting for

Pub

Publication approval


3.
b.13
19Project Manager
GGG sign-off
for publication (pub) approval
of public review comment resolutionrep.s
Stage 3c - Publication
3.
c.1
20Head of Standards
Heads of Standards Approval and notification to all Heads
3.
c.2
21Copy Editor
Final Copy-editing Check
3.
c.3
22Project Manager
Address copy-editing comments
3.
c.4Raise a ticket to IT to
23Project Manager
Lockdown Wiki space

Lockdown Wiki space


3.
c.5
24Copy editor
Create
PDF
Publication
3.
c.6
25Project Manager
Export public review comments

Project Manager
Update metadata staging
3.
c.7
26Software Engineer
Scrape and load to Stage/Prod 
3.
c.8
27Project Manager
Post on WebsiteRaise a ticket to IT to post on Website
3.
c.9
28Project Manager

Archive Wiki

spaceRaise 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?

Software DeveloperScrape and load to DEVSuccess confirms that there are no issues with structures