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.


AccountableTAUGComments

Stage 1 – Concept Modeling 

1.1Metadata DeveloperAnalyze 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 mapsCMAPS
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
1.6Project ManagerUpdate project information and hold project review.What is this?  Is this the project kickoff with team?
Stage 2 – Development of Draft Standards 
2.1Project Team LeadProject 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?

2.2Project Team LeadConcept 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










2.3Project Team LeadConcept 2
2.4Project Team LeadConcept 3
2.5Project Team LeadConcept 4
2.6Project Team LeadConcept 5
2.7Project Team LeadConcept 6
2.8Project Team LeadConcept 7
2.9Project Team LeadConcept 8
2.10Project Team LeadConcept 9
2.11Project Team LeadConcept 10
2.12Project ManagerFinal review of TAUG with Metadata AnalystTAUGs 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







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