You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 9 Next »

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 

Metadata 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)

Metadata Developer

Create concept mapsCMAPS

Clinical Expert

Review concepts maps Review with clinical and/or relevant SMEs (if applicable)

Metadata Developer

Refine information requirements (deliverables)Is this some kind of artifact that is shown to GGG? if not, what is it they review?

GGG Lead

GGG provides approval to move forward
Project ManagerUpdate project information and hold project review.What is this?  Is this the project kickoff with team?
Stage 2 – Development of Draft Standards 
Project 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?

Project 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

Project Team LeadConcept 2
Project Team LeadConcept 3
Project Team LeadConcept 4
Project Team LeadConcept 5
Project Team LeadConcept 6
Project Team LeadConcept 7
Project Team LeadConcept 8
Project Team LeadConcept 9
Project Team LeadConcept 10
Project 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.

Project Manager

Schedule GGG review

GGG Lead

GGG approves TAUG for Internal Review
Software Developer
This indicates that there are no issues with structures







  • No labels