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.
| Accountable | Standards | IG | Comments |
|---|---|---|---|
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 | ||
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. | ||
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. | ||
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. | ||
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 | ||
| Project Manager | Updates 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 | Analyze specific content needed | 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. | ||
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 | ||
| 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. | ||
| 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. | ||
Global Governance Group | Approves the modeling before the standard may be posted for internal review. | ||
| Software Developer | Scrape and load to DEV | This indicates that there are no issues with structures | |