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Role | Responsibilities |
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Project Manager | - Leads one or more TA projects
- Manages projects by coordinating sub-teams, schedules, and deliverables according to the 10-12 month development timeline
- Ensures effective team interactions and overall project communication
- Collaborates with Education Representative to develop TA education materials, or assigns a TA team member, and coordinates team review of draft and final training materials
- Verify that all applicable regulations are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document.
Prepares the scoping package for submission. Once the Project Charter is approved, the Project Manager posts Posts it in the team space on the CDISC Wiki once the Project Charter is approved.
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Project Team | - Contribute to the design, development, publication and support of the new standards product
- Ensure applicable regulatory guidance and requirements are taken into account.
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Clinical TA Expert(s)Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminologyFacilitates consolidation of clinical data elements and termsResponsible for the medical content of TA User Guides by writing, and sometimes reviewing sections of data standards that require clinical expertise, with the Medical WriterReviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as neededEnsures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation communityAssists team as needed to resolve commentsCollaborates on the development and review of TA education materials to ensure accuracy and completeness | Ensures the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking. Completes the literature review for the therapeutic area and works with the Project Manager and the ADaM Representative to compile a reference list.
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EVS Terminology Expert | - Performs
inputs process, checking existing CDISC CT, NCIt, caDSR, and MeshBuilds and reviews initial list of inputs produced with the teamOversees initial gap assessment against existing terminologyIdentifies relevant TA clinical core concepts with Program & Project ManagersWorks with Terminology Team to develop needed new terms within the project timelineCollaborates on development and review of TA education materials to ensure accuracy and completeness- an initial gap analysis against CDISC CT to identify concepts that exist in CDISC standards for each mapped concept
- Inputs the code list name, code list NCIt c-code reference, CDISC submission value, and submission value NCIt c-code reference onto the Concept Listing Spreadsheet for each mapped concept
- Provides comments on concepts to include where a term may be mapped within the CDISC model, issues regarding term granularity, valid value sets, etc.
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ADaM SME | - Reviews the output of the initial scoping and planning stage and identifies potential areas that will require new constructs in ADaMCompletes the gap analysis on ADaM mappings
- Ensures proposed standards are aligned with ADaM
- Collaborates on the development and review of TA education materials to ensure accuracy and completeness, as needed
- Holds ADaM assessment meeting if applicable.
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TAPSC/TLC | - Receives Project Charter(TAs)
- for approval to proceed with
the next stage of the development process- Stage 1.
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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.
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