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 | Milestone | Comments | |
|---|---|---|---|
| 0.1 | Project Manager | Create project artifacts (Jira, Wiki) | For TAUGs, grant proposal has been signed and project is slated to start |
| 0.2 | Project Manager | Create project plan from template | I think this will be a new action for Alana, normal for Dana except that it comes from a template now which can be added to in 0.5 |
| 0.3 | Project Manager | Review scope | For TAUGs, this includes review of signed off Proposal (eg. 18 months, 10 concepts) |
| 0.4 | Project Manager | Create project charter Wiki page | Wiki page can contain proposal but high level details should be included on the page. Charter page should be from a common template so that all project charters could be exported and seen in a spreadsheet. Would it be possible to identify common information that both SD and DS are interested in to create template? That way projects that don't include SD would still be consistent and they'd be able to be reported along with the SD, SD/DS projects. |
| 0..5 | Project Manager | Update project plan | At this time additional items are added to Jira plan that was created by the template. |
| 0.6 | Metadata Analyst | Review project plan, scope, and Wiki structures with Project Manager | PM and Metadata Analysts meet at start of the project to make sure both departments aligned, however, PM and Metadata Analysts should continue to review during Stage 1 & 2 and should plan meeting cadence at this time. |
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 Lead | Domain long name alignment | ||
| Project Team Lead | New QX domain | ||
| Project Team Lead | New DC domain (draft name, MSI) | ||
| Project Team Lead | New 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 Lead | Revise BE, BS, and RELSPEC | ||
| Project Team Lead | Revise DV domain | ||
| Project Team Lead | Revise MI domain | ||
| Project Team Lead | New variables | ||
| Project Team Lead | Deprecation of existing variables | ||
| Project Team Lead | Incorporate CDISC glossary text references into the SDTMIG | ||
| Project Team Lead | Decision trees | ||
| Project Team Lead | Suppqual -> NSV | ||
| Project Team Lead | ACTARM | ||
| Project Team Lead | RWE/RWD | ||
| Project Team Lead | Conformance - legacy review (e.g., should -> must) | ||
| Project Team Lead | 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. | ||
| Stage 3a - Internal Review | |||
| 3.a.1 | Project Manager | Team Review before GGG | |
| 3.a.2 | Project Manager | Resolution of team review issues | |
| 3.a.3 | Project Manager | Material prepared for GGG Internal Review (IR) | |
| 3.a.4 | Head of Data Standards | GGG meeting for IR approval | |
| 3.a.5 | Project Manager | Internal Review | |
| 3.a.6 | Project Manager | IR comment resolution | |
| 3.a.7 | Copy Editor | Pre-public review copy editing | This needs to start during IR and Questions / Comments need to be entered into Jira. |
| 3.a.8 | Project Manager | Prepare for GGG Public Review (PR) | |
| 3.a.9 | GGG Lead | GGG meeting for PR approval | |
| 3.a.10 | GGG Lead | Sign-off for PR Approval | |
| Stage 3b - Public Review | |||
| 3.b.1 | Software Engineer | Scrape and load to Stage/Prod as Draft | |
| 3.b.2 | Publications Team* | Post for Public Review (Website, Wiki) | *This needs to be one role |
| 3.b.3 | Project Manager | Public Review (PR) | |
| 3.b.4 | Project Manager | PR comment resolution | this is PM but blue because it's SD/DS effort |
| 3.b.5 | Project Manager | FDA review | |
| 3.b.6 | Project Manager | FDA comment resolution | |
| 3.b.7 | Software Engineer | Scrape and load to QA | |
| 3.b.8 | Project Manager | Perform UAT with Metadata Analyst | This includes identifying reviewers, etc. |
| 3.b.9 | Project Manager | UAT Comment resolution with Metadata Analyst | |
| 3.b.10 | Project Manager | UAT Validation of fixes | |
| 3.b.11 | Project Manager | Pub material ready for GGG | |
| 3.b.12 | Heads of Standards | GGG meeting for Pub approval | |
| 3.b.13 | Project Manager | GGG sign-off for publication (pub) approval | |
| Stage 3c - Publication | |||
| 3.c.1 | Head of Standards | Heads of Standards Approval | |
| 3.c.2 | Copy Editor | Final Copy-editing Check | |
| 3.c.3 | Project Manager | Address copy-editing comments | |
| 3.c.4 | Project Manager | Lockdown Wiki space | Raise a ticket to IT to Lockdown Wiki space |
| 3.c.5 | Copy editor | Create PDF | |
| 3.c.6 | Project Manager | Export public review comments | |
| 3.c.7 | Software Engineer | Scrape and load to Stage/Prod | |
| 3.c.8 | Project Manager | Post on Website | Raise a ticket to IT to post on Website |
| 3.c.9 | Project Manager | Archive Wiki space | Raise a ticket to Comms to Archive space |
| 3.c.10 | GGG Lead | GGG approves scope | Part of template but if not applicable, canceled when project plan created. Where is the formal project kickoff with the team where the charter/scope, wiki, and team processes reviewed? |
| Software Developer | Scrape and load to DEV | Success confirms that there are no issues with structures | |