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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.

AccountableStandardsDana's Steps, Comments, etc.TAUGIGComments

Stage 1 – Concept Modeling 

Project Team

Reviews questionnaires and scales.

Initiates the process for collecting the required copyright permissions.



Concept modeling is depending on new scope approved from GGG

QRS Representative

Expands the initial gap analysis

Identifies questionnaires that are needed

Initiates the process for acquiring permissions. 





QRS Representative / Clinical Expert

Reviews the list of instruments and identifies those that need development.





Metadata Developer

Models Concepts


Model and develop biomedical concepts

Metadata Developer 

(Concept Developer)

Defines any concepts that have not been addressed in current CDISC standards





Clinical Expert

Evaluates new and different research concepts to ensure the data are clearly understood.


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

Metadata Developer

Creates concept maps





SDTM Expert / SDS Team

Works with the Project Team to address areas not covered by the current SDTMIG.





Metadata Developer

Refines Deliverable Plan. 


Refine information requirements (deliverables)

Clinical Expert / Clinical SMEs

Ensures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing.






Project Team

Refines the concept maps and list of concepts as necessary.


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Project Manager

Submits all examples to GGG





Project Team

Refines the examples based on GGG feedback


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GGG (Global Governance Group)

Approves the modeling before the team can move to stage 2


GGG Approval to move forward

Project Manager

Updates the project plan and charter.

Notifies all parties involved.

Performs CDISC project review.


Update project information and hold project review.

Stage 2 – Development of Draft Standards 

Metadata Developer

Evaluate the templates or spreadsheets needed for the project and create any additional templates required





Metadata Developer / SDTM Expert

Determines what SDTMIG examples are needed for the standard.





Metadata Developer / CDASH Representative

Determines what CDASH examples are needed for the TA User Guide.





TA Statistical Programmer

ADaM Expert

Determines what analysis, metadata, and ADaM dataset examples are needed for the TA User Guide. 





Metadata Developer

Builds on the initial gap analysis to determine if new metadata needs to be developed.





Metadata Developer

Develops metadata and examples.





Project Team

Analyze specific content needed

Restructure metadata tables



Examine concepts and consider what specific content is needed as part of the final standards product.
Metadata Developer

Creates sample data for key concepts




Creates sample data to improve understanding of all key concepts

Technical Writer

Metadata Developers and Concept Modelers

Begins to build the standard by incorporating content and examples as they are developed by the Metadata Developers and Concept Modelers





Clinical TA Expert / Medical Writer

Writes relevant sections of the TA User Guide and reviews examples to ensure clinical accuracy and plausibility.

Update labels in SDTMIG




Concept Developer

Copies the template sheet to a new sheet

Fills in the concept-level metadata

Deletes any concept variable rows that are not relevant for the concept, populates or modifies Controlled Terminology and SDTM variable information as needed

Adds relevant information about associations with other concepts

Controlled terminology





Domain long name alignment






New QX domain






New DC domain (draft name, MSI)





TA Team

Drafts a Therapeutic Area Specification in collaboration with the FDA to show the different versions of the SDTM and how they relate to domains and variables contained in TA User Guides. 

New GI domain, from SDTM draft domains





Revise BE, BS, and RELSPEC






Revise DV domain






Revise MI domain






New variables






Deprecation of existing variables






Incorporate CDISC glossary text references into the SDTMIG






Decision trees






Suppqual -> NSV






ACTARM






RWE/RWD






Conformance - legacy review (e.g., should -> must)






Incorporate SDTMIG-AP





Project Manager

Refers to the comments received from the Check of Concepts and ensures issues were resolved appropriately.





Project Manager

Resolves gaps or discrepancies and prepares the draft standard for the Internal Review.





Project Manager

Conducts a project review with the Modeling Experts, as needed.





Project Manager

Alerts the Global Governance Group when the draft is nearing internal review.


Add to GGG schedule

Global Governance Group

Approves the modeling before the standard may be posted for internal review.


GGG approve TAUG for Internal Review

Software DeveloperScrape and load to DEV


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