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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. These work instructions will be used to create template project plans.
| 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 | Project Manager | Scope approval if required | Funder, project team, head of standards |
| 0.7 | 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. |
| 1.1 | |||
Project Manager Standards Developer | Analyze concept list |
| requirements | Based on concept list, do we need a diagram Do we need to explain further If yes, start CMAPS (1 or more) |
| 1.2 |
Standards Developer | Create concept maps | CMAPS | |
| 1.3 | Clinical Expert | Review concepts maps | Review with clinical and/or relevant SMEs (if applicable) |
Metadata Developer
GGG Lead
| Stage 2 – Development of Draft Standards | |||
| 2. | |||
Examine concepts and consider what specific content is needed as part of the final standards product.
Is this different than what is in Stage 1 analysis?
| 2 |
| Standards Developer |
| Concept 1 | For each concept, create: Content - Examine concepts and consider what specific content is needed as part of the final standards product. Examples - Creates sample data to improve understanding of all key concepts. CDASH, SDTM, ADaM and they'd all flow through (sometimes no ADaM ). Sometimes just text, list of lab tests Involve QRS and CT assume this is a lead rep. | |
| 2.3 |
| Standards Developer | Concept 2 |
| 2.4 |
| Standards Developer | Concept 3 |
| 2.5 |
| Standards Developer | Concept 4 |
| 2.6 |
| Standards Developer | Concept 5 |
| 2.7 |
| Standards Developer | Concept 6 |
| 2.8 |
| Standards Developer | Concept 7 |
| 2.9 |
| Standards Developer | Concept 8 |
| 2.10 |
| Standards Developer | Concept 9 |
| 2.11 |
| Standards Developer | Concept 10 | ||
| 2.12 | Project Manager | Team Review before GGG | |
| 2.13 | Project Manager | Resolution of team review issues | |
| Project Manager | TA specification creation | ||
| 2.14 | Project Manager | Final review of TAUG with Metadata Analyst | TAUGs are not currently in library, but it would be good to establish this now for when they do get added. This would actually be a final, since they would have been meeting every month, 3 months, etc. as necessary. not applicable for now |
| 2.15 | Project Manager | Material prepared for GGG Internal Review (IR) | |
| 2.13 | Project Manager | Schedule GGG review | |
| 2.16 | GGG Lead | GGG meeting for IR approval | |
| Stage 3a - Internal Review | |||
| 3.a.1 | Project Manager | Internal Review | Make necessary updates |
| 3.a.2 | Project Manager | IR comment resolution | |
| 3.a.3 | Copy Editor | Pre-public review copy editing | This needs to start during IR and Questions / Comments need to be entered into Jira. |
| 3.a.4 | Project Manager | Prepare for GGG Public Review (PR) | |
| 3.a.5 | Project Manager | Schedule GGG meeting for PR approval | |
| 3.a.6 | GGG Lead | Sign-off for PR Approval | |
| Stage 3b - Public Review | |||
| 3.b.1 | Software Engineer | Scrape and load to Stage/Prod as Draft | |
| 3.b.2 | |||
| Project Manager | Post for Public Review (Website, Wiki) | * |
| done by ticket to Comms | |||
| 3.b.3 | Project Manager | Public Review (PR) | Make necessary updates (Erin puts in tickets to make updates) |
| 3.b.4 | Project Manager | PR comment resolution | this is PM but blue because it's SD/DS effort |
| 3.b.5 | Project Manager | FDA review | |
| 3.b.6 | Project Manager | FDA comment resolution | |
| 3.b.7 | Software Engineer | Scrape and load to QA | |
| 3.b.8 | Project Manager | Perform UAT with Metadata Analyst | This includes identifying reviewers, etc. |
| 3.b.9 | Project Manager | UAT Comment resolution with Metadata Analyst | |
| 3.b.10 | Project Manager | UAT Validation of fixes | |
| 3.b.11 | Project Manager | Pub material ready for GGG | |
| 3.b.12 |
| Project Manager | GGG meeting for |
Publication approval | ||
| 3.b.13 | Project Manager | GGG sign-off |
| of public review comment resolution | rep.s | ||
| Stage 3c - Publication | |||
| 3.c.1 | Head of Standards | Heads of Standards Approval | |
| 3.c.2 | Copy Editor | Final Copy-editing Check |
| 3.c.3 | Project Manager | Address copy-editing comments |
| 3.c.4 | Project Manager | Lockdown Wiki space |
Raise a ticket to IT to Lockdown Wiki space
| ||
| 3.c.5 | Copy editor | Create |
| Publication | |||
| 3.c.6 | Project Manager | Export public review comments | |
| 3.c.7 | Software Engineer | Scrape and load to Stage/Prod | |
| 3.c.8 | Project Manager | Post on Website | Raise a ticket to IT to post on Website |
| 3.c.9 | Project Manager | Archive Wiki |
space |