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
Stage 0 – Scoping & Planning
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.
Stage 1 – Concept Modeling
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
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?

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TAUG

Instructions