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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 |
|---|
| TAUG | Comments | ||
|---|---|---|---|
Project Team
Reviews questionnaires and scales.
Initiates the process for collecting the required copyright permissions.
QRS Representative
Expands the initial gap analysis
Identifies questionnaires that are needed
Initiates the process for acquiring permissions.
| 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 |
QRS Representative / Clinical Expert
Reviews the list of instruments and identifies those that need development.
Metadata Developer
Models 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.
| with clinical and/or relevant SMEs (if applicable) |
Metadata Developer
Creates concept maps
SDTM Expert / SDS Team
| 1.4 | Metadata Developer |
Project Team
Refines the concept maps and list of concepts as necessary.
Project Manager
Submits all examples to GGG
Project Team
Refines the examples based on GGG feedback
GGG (Global Governance Group)
Approves the modeling before the team can move to stage 2
Updates the project plan and charter.
Notifies all parties involved.
Performs CDISC project review.
| 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.
| 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 | |||
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.
Develops metadata and examples.
Project Team
Analyze specific content needed
Restructure metadata tables
| 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. |
Creates sample data for key concepts
Examples - 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
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
. 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 |
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.
Global Governance Group
Approves the modeling before the standard may be posted for internal review.