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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 |
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Milestone | Comments | |||
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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
Clinical Expert
Evaluate new and different research concepts to ensure the data are clearly understood
0.1 | Project Manager | Create project artifacts (Jira, Wiki) | For TAUGs, grant proposal has been signed and project is slated to start | |
0.2 | Project 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 | |
0.3 | Project Manager | Review scope | For TAUGs, this includes review of signed off Proposal (eg. 18 months, 10 concepts) | |
0.4 | Project 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..5 | Project Manager | Update project plan | At this time additional items are added to Jira plan that was created by the template. | |
0.6 | Project Manager | Scope approval if required | Funder, project team, head of standards | |
0.6 | Project 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. | |
Metadata Developer | Evaluate and Define concepts | Concept Developer | ||
Metadata Developer | Creates concept maps |
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
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
Refine examples based on GGG feedback
GGG Lead
GGG approves the modeling
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.
Develops metadata and examples.
Project Team Lead
Analyze specific content needed and restructure metadata tables
Creates sample data for 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
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.
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 Manager | Standards Development | Revise existing domains |
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Project Manager | Standards Development | Create New Domains |
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Project Manager | Standards Development | Revise Non-domain sections |
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Project Manager | Standards Development | Add new Non-domain sections | ||
Project Manager | Review | Check all cross-references |
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Project Manager | Review | Revise appendices (team members, revision history, etc.) | ||
Project Manager | Review | Evaluate variables to be deprecated | ||
Project Manager | Review | CT Final check before IR |
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Project Manager | Review | Work with Data Science to prepare for IR
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like TAUG 2.12 | |
Project Manager | Material prepared for GGG Internal Review (IR) | |||
Project Manager | Schedule GGG review | Alert the Global Governance Group when the draft is near internal review. | ||
GGG Lead | GGG meeting for IR approval | GGG approves the modeling before the standard may be posted for internal review. | ||
Stage 3a - Internal Review | ||||
3.1 | Project Manager | Internal Review | ||
3.2 | Project Manager | IR comment resolution | ||
3.3 | Copy Editor | Pre-public review copy editing | This needs to start during IR and Questions / Comments need to be entered into Jira. | |
3.4 | Project Manager | Material prepared for GGG Public Review (PR) | ||
3.5 | Project Manager | Schedule GGG meeting for PR approval | ||
Project Manager | GGG meeting for PR approval | |||
3.6 | GGG Lead | Sign-off for PR Approval | ||
Stage 3b - Public Review | ||||
Project Manager | Update metadata staging | |||
3.7 | Software Engineer | Scrape and load to Stage/Prod as Draft | ||
3.8 | Project Manager | Post for Public Review (Website, Wiki) | *done by ticket to Comms | |
3.9 | Project Manager | Public Review (PR) | Make necessary updates (Erin puts in tickets to make updates) | |
3.10 | Project Manager | PR comment resolution | this is PM but blue because it's SD/DS effort | |
3.11 | Project Manager | FDA review | ||
3.12 | Project Manager | FDA comment resolution | ||
Project Manager | Update metadata staging | |||
3.13 | Software Engineer | Scrape and load to QA | ||
3.14 | Project Manager | Perform UAT with Metadata Analyst | This includes identifying reviewers, etc. | |
3.15 | Project Manager | UAT Comment resolution with Metadata Analyst | ||
3.16 | Project Manager | UAT Validation of fixes | ||
3.17 | Project Manager | Pub material ready for GGG | ||
3.18 | Project Manager | GGG meeting for Publication approval | ||
3.19 | Project Manager | GGG sign-off of public review comment resolution | rep.s | |
Stage 3c - Publication | ||||
3.20 | Head of Standards | Heads of Standards Approval and notification to all Heads | ||
3.21 | Copy Editor | Final Copy-editing Check | ||
3.22 | Project Manager | Address copy-editing comments | ||
3.23 | Project Manager | Lockdown Wiki space | ||
3.24 | Copy editor | Create Publication | ||
3.25 | Project Manager | Export public review comments | ||
Project Manager | Update metadata staging | |||
3.26 | Software Engineer | Scrape and load to Stage/Prod | ||
3.27 | Project Manager | Post on Website | Raise a ticket to IT to post on Website | |
3.28 | Project Manager | Archive Wiki space |
New QX 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 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 internal review.
GGG Lead
GGG approves the modeling before the standard may be posted for internal review.