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 | Comments |
|---|---|---|
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 | 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 | |
| Domain long name alignment | ||
New QX domain | ||
| New DC domain (draft name, MSI) | ||
| New GI domain | ||
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. | |
GGG Lead | GGG approves the modeling before the standard may be posted for internal review. | |
| Software Developer | Scrape and load to DEV | Success confirms that there are no issues with structures |