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.

AccountableIGComments

Stage 1 – Concept Modeling 

Project Team Lead

Reviews QRS and initiate process for collecting the required copyright permissions.

Reviews questionnaires and scales.

Initiates the process for collecting the required copyright permissions.

QRS Representative

Expands initial gap analysis, identify needed questionnaires and acquire permissions.


Expands the initial gap analysis

Identifies questionnaires that are needed

Initiates the process for acquiring permissions. 

QRS Representative / Clinical Expert

Review the list of instruments and identify those that need development.


Metadata Developer

Model Concepts


Metadata Developer 


Define concepts that have not been addressed in current CDISC standards

Concept Developer

Clinical Expert

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


Metadata Developer

Creates concept maps


Foundational Standard Expert 

Work with the Project Team to address areas not covered by the current foundational standard IG.


Metadata Developer

Refine Deliverable Plan


Clinical Expert / SME

Review and confirm core concepts are complete, adequate, and appropriate


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

Project Team Lead

Refine concept maps and list of concepts as necessary


Project Manager

Submit all examples to GGG


Project Team Lead

Refine examples based on GGG feedback


GGG  Lead

GGG approves the modeling 

GGG approves the modeling before the team can move to stage 2
Project Manager

Update the project plan and charter

Notifies all parties involved.

Performs CDISC 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 Lead

Analyze specific content needed and 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

Create relevant sections of the TA User Guide, update label in IG, and review examples to ensure clinical accuracy and plausibility.

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

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

Identifies required Controlled terminology


Project Team LeadDomain long name alignment
Project Team Lead

New QX domain


Project Team LeadNew DC domain (draft name, MSI)
Project Team LeadNew GI domain 

TA Team Lead

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. 


Project Team LeadRevise BE, BS, and RELSPEC
Project Team LeadRevise DV domain
Project Team LeadRevise MI domain
Project Team LeadNew variables
Project Team LeadDeprecation of existing variables
Project Team LeadIncorporate CDISC glossary text references into the SDTMIG
Project Team LeadDecision trees
Project Team LeadSuppqual -> NSV
Project Team LeadACTARM
Project Team LeadRWE/RWD
Project Team LeadConformance - legacy review (e.g., should -> must)
Project Team LeadIncorporate 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.


GGG Lead

GGG approves the modeling before the standard may be posted for internal review.


Software DeveloperScrape and load to DEVSuccess confirms that there are no issues with structures






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