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 | Known scope gets approved by GGG. However, in some cases new domains and variables go to GGG as they come up now through development. Part of template but if not applicable, canceled when project plan created. |
| 1.1 | Metadata 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 | Metadata Developer | Create concept maps | CMAPS |
| 1.3 | Clinical Expert | Review concepts maps | Review with clinical and/or relevant SMEs (if applicable) |
| 1.4 | Metadata Developer | Refine information requirements (deliverables) | Is this some kind of artifact that is shown to GGG? if not, what is it they review? |
| 1.5 | GGG Lead | GGG provides approval to move forward | |
| 1.6 | Project Manager | Update project information and hold project review. | What is this? Is this the project kickoff with team? |
| Stage 2 – Development of Draft Standards | |||
| 2.1 | Project Team Lead | Project Team analyzes concept list | 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? |
| 2.2 | Project Team Lead | 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 |
| 2.3 | Project Team Lead | Concept 2 | |
| 2.4 | Project Team Lead | Concept 3 | |
| 2.5 | Project Team Lead | Concept 4 | |
| 2.6 | Project Team Lead | Concept 5 | |
| 2.7 | Project Team Lead | Concept 6 | |
| 2.8 | Project Team Lead | Concept 7 | |
| 2.9 | Project Team Lead | Concept 8 | |
| 2.10 | Project Team Lead | Concept 9 | |
| 2.11 | Project Team Lead | Concept 10 | |
| 2.12 | 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. |
| 2.13 | Project Manager | Schedule GGG review | |
| 2.14 | GGG Lead | GGG approves TAUG for Internal Review | |
| Stage 3a - Internal Review | |||
| 3.a.1 | Project Manager | Team Review before GGG | |
| 3.a.2 | Project Manager | Resolution of team review issues | |
| 3.a.3 | Project Manager | Material prepared for GGG Internal Review (IR) | |
| 3.a.4 | Head of Data Standards | GGG meeting for IR approval | |
| 3.a.5 | Project Manager | Internal Review | |
| 3.a.6 | Project Manager | IR comment resolution | |
| 3.a.7 | Copy Editor | Pre-public review copy editing | This needs to start during IR and Questions / Comments need to be entered into Jira. |
| 3.a.8 | Project Manager | Prepare for GGG Public Review (PR) | |
| 3.a.9 | GGG Lead | GGG meeting for PR approval | |
| 3.a.10 | 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 | Publications Team* | Post for Public Review (Website, Wiki) | *This needs to be one role |
| 3.b.3 | Project Manager | Public Review (PR) | |
| 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 | Heads of Standards | GGG meeting for Pub approval | |
| 3.b.13 | Project Manager | GGG sign-off for publication (pub) approval | |
| 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 PDF | |
| 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 | Raise a ticket to Comms to Archive space |
| 3.c.10 | 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? |