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.
| Accountable | Milestone | Comments | |
|---|---|---|---|
| 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 | Metadata Analyst | Review 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. |
| 0.7 | Project Manager | Submit 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. |
| 0.8 | GGG Lead | GGG 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? |
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 Manager | Variables to be deprecated | ||
| Project Manager | Check all cross-references |
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| Project Manager | Revise appendices (team members, revision history, etc.) | ||
| Project Manager | Revise Non-domain sections |
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| Project Manager | Add new Non-domain section | ||
| Project Manager | Revise existing domains |
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| Project Manager | Create New Domains |
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| Project Manager | CT Final check before IR |
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| Project Manager | Data Sciences Checks Before IR |
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 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 | Prepare for GGG Public Review (PR) | |
| 3.5 | Project Manager | Schedule GGG meeting for PR approval | |
| 3.6 | GGG Lead | Sign-off for PR Approval | |
| Stage 3b - Public Review | |||
| 3.7 | Software Engineer | Scrape and load to Stage/Prod as Draft | |
| 3.8 | Publications Team* | Post for Public Review (Website, Wiki) | *This needs to be one role |
| 3.9 | Project Manager | Public Review (PR) | |
| 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 | |
| 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 | Heads of Standards | GGG meeting for Pub approval | |
| 3.19 | Project Manager | GGG sign-off for publication (pub) approval | |
| Stage 3c - Publication | |||
| 3.20 | Head of Standards | Heads of Standards Approval | This appears to be a duplicate of GGG approval, Heads are on GGG, is this step needed? |
| 3.21 | Copy Editor | Final Copy-editing Check | Why is this not done after 3.12, 3.13, or 3.16? GGG approval for publication should not have any changes made thereafter. |
| 3.22 | Project Manager | Address copy-editing comments | This would not be needed if done after 3.16 |
| 3.23 | Project Manager | Lockdown Wiki space | Raise a ticket to IT to Lockdown Wiki space This should be immediately after GGG approval |
| 3.24 | Copy editor | Create PDF | |
| 3.25 | Project Manager | Export public review comments | |
| 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 | |