Completed by:
Date Completed:
Name and Version of Project:

This checklist provides a quality control check for Stage 0 - Scoping. All tasks on this checklist must be completed prior to submitting the Scoping Package to the TAPSC at the completion of Stage 0.

  •  Clinical TA Expert(s) provided characterization of the disease:
    1. identified overall disease characteristics
    2. identified common endpoints
    3. identified overall disease measures
  • Project Manager modified the Charter Template to contain disease characteristics:
    1. types of studies
    2. subject population
    3. specific indication(s)
  • Project Team requested CRFs and other information from companies, as applicable
  • Project Manager checked for existence of FDA Requirements Document.
  • Project Manager consulted the Clinical Outcome Assessment Compendium (PDF: Draft Document)
  • For v2, or subsequent, standards being developed- Project manager and team reviewed the v1 Standard and the v1 Public Comment Resolution Spreadsheet
  • Clinical TA Expert(s) and Project Team have reviewed FDA requirements document (where available) and have built the initial list of concepts using the Concept Listing Spreadsheet.*
  • Project Team performed initial gap analysis for inclusion in the Project Charter:
    1. Terminology Expert performed initial gap analysis against Controlled Terminology, and added concept descriptions and c-code references for existing terminology to the concept listing spreadsheet, as appropriate.
    2. Project Team and Foundational Team Representatives performed initial SDTM, CDASH and ADaM gap analysis.*
  •  Project Team made recommendations on which concepts were marked in or out of scope (mandatory concepts for v1).
  •  Input from targeted Key Opinion Leaders (KOLs) has been incorporated in the Concept Listing Spreadsheet, as appropriate.
  •  Project Team approved the Concept Listing Spreadsheet.
  •  Project Team assembled the Scoping Package:
    1. Draft Project Charter
    2. Concept Listing Spreadsheet
    3. Documentation of input from FDA/Key Opinion Leaders (KOLs) and resolutions
    4. Scoping Checklist
    5. Team Member List
    6. List of Key Medical and Regulatory guidance
    7. Draft Project Plan
  •  Project Manager submitted/re-submitted (potential feedback loop) the Scoping Package to the TAPSC for approval.
  •  CDISC Experts performed a project review

*Draft concepts are sent to these groups earlier in the process

If a check box is left unchecked, explain the reason:

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