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RoleResponsibilities
Project Manager
  1. Leads one or more TA projects
  2. Manages projects by coordinating sub-teams, schedules, and deliverables according to the 10-12 month development timeline
  3. Ensures effective team interactions and overall project communication
  4. 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
  5. 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.

  6. Prepares the scoping package for submission.

  7. 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.

Project Team
  1. Contribute to the design, development, publication and support of the new standards product
  2. Ensure applicable regulatory guidance and requirements are taken into account.
Clinical TA Expert(s)
  • Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminology
  • Facilitates consolidation of clinical data elements and terms
  • Responsible for the medical content of TA User Guides by writing, and sometimes reviewing sections of data standards that require clinical expertise, with the Medical Writer
    • Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed

    1. Ensures

      examples in

      the

      TA guide are

      appropriate

      and clinically accurate, ensures the draft standard is understandable for the implementation community
    2. Assists team as needed to resolve comments
    3. Collaborates on the development and review of TA education materials to ensure accuracy and completeness

    4. Ensures the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking.

    5. Completes the literature review for the therapeutic area and works with the Project Manager and the ADaM Representative to compile a reference list.

    EVS Terminology Expert
    1. Performs
    inputs process, checking existing CDISC CT, NCIt, caDSR, and Mesh
  • Builds and reviews initial list of inputs produced with the team
  • Oversees initial gap assessment against existing terminology
  • Identifies relevant TA clinical core concepts with Program & Project Managers
  • Works with Terminology Team to develop needed new terms within the project timeline
  • Collaborates on development and review of TA education materials to ensure accuracy and completeness
    1. an initial gap analysis against CDISC CT to identify concepts that exist in CDISC standards for each mapped concept
    2. 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
    3. Provides comments on concepts to include where a term may be mapped within the CDISC model, issues regarding term granularity, valid value sets, etc. 
    ADaM SME
    1. 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
    2. Ensures proposed standards are aligned with ADaM
    3. Collaborates on the development and review of TA education materials to ensure accuracy and completeness, as needed
    4. Holds ADaM assessment meeting if applicable.
    TAPSC/TLC
    1. Receives Project Charter(TAs)
     
    1. for approval to proceed with
    the next stage of the development process
    1. Stage 1.

    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.

    Step #RoleInstructions
    1.0


    		EVS Terminology Expert / Clinical TA Expert (s)

    Gathers CRFs, perform a Public Database Search for existing TA Concepts

    .2

    .

    0



    		Project TeamEnsure applicable regulatory guidance and requirements are taken into account.
    2.1


    		Clinical TA Expert(s)/Project ManagerVerifies that all applicable  regulatory guidance are taken into account in the standard under development and that such regulatory documents are referenced in the appendix of the standards document.
    3.0


    		Clinical TA Expert(s)

    Identifies the appropriate core concepts and that the standards under development are aligned with current medical practice and thinking. 

    4.0


    		Project ManagerReview scoping materials.
    5.0
    Items under consideration

    EVS Terminology Expert

    		Performs Controlled Terminology Gap Analysis.
    6.0


    		ADaM SMEHolds ADaM assessment meeting if applicable
    .7
    .
    0


    		Project ManagerDraft project charter and project plan
    .8
    .
    0


    		Project ManagerReview the entire scope package with the Data Science representative including the expected required Wiki structures.
    9.0


    		Project Manager

    Submit scoping package to TAPSC/TLC and plans kick-off activities.

    10.0


    		TAPSC/TLC

    Receives Project Charters(TAs) for approval to proceed with the next stage of the development process.

    11.0


    		Project Manager

    Posts Project Charter in the team space on the CDISC Wiki.





    		Add agreed upon scoping items to development

    General Workflow

    Include a general workflow diagram that summarizes this Work Instruction.

    ...