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Purpose

Ensure that the project is well defined with clear and achievable requirements and goals.

Scope

Information collected is summarized in the Project Charter (TAs) that is submitted to the Team Leads/TAPSC for approval to proceed with the next stage of the development process.

Prerequisites

The project proposal is approved by the Team Leads/TAPSC.

Definitions

List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.

TermDefinition
TATherapeutic Area.
TAPSCTherapeutic Area Standards Program Steering Committee.

CRFs

Case Report Forms.
EVSNational Cancer Institue (NCI) Enterprise Vocabulary Services.
SMEsSubject Matter Experts.
TLCTechnical Leadership Committee. The TLC is made up of Foundational Standards Team Leads. This committee discusses issues pertaining to the Foundational Standards. The TLC also develops the agenda for CDISC IntraChanges and typically leads sessions during these events.
ADaM

Analysis Data Model.  ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, and traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

SMESubject Matter Expert.

Roles & Responsibilities

Lists all roles and their responsibilities relevant to this Work Instruction.

RoleResponsibilities
Project Manager

Prepares the scoping package for submission.

Once the Project Charter is approved, the Project Manager posts it in the team space on the CDISC Wiki.

  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


Project TeamContribute to the design, development, publication and support of the new standards product
Clinical TA Expert(s)

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.

  1. Functions as the Subject Matter Expert (SME) for therapeutic area concepts, clinical endpoints and terminology
  2. Facilitates consolidation of clinical data elements and terms
  3. 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
  4. Reviews and assists in the search of medical literature and regulatory guidance to ensure appropriate references are included, cited and followed, as needed
  5. Ensures examples in the TA guide are appropriate and clinically accurate, ensures the draft standard is understandable for the implementation community
  6. Assists team as needed to resolve comments
  7. Collaborates on the development and review of TA education materials to ensure accuracy and completeness
EVS Terminology Expert
  1. Performs inputs process, checking existing CDISC CT, NCIt, caDSR, and Mesh
  2. Builds and reviews initial list of inputs produced with the team
  3. Oversees initial gap assessment against existing terminology
  4. Identifies relevant TA clinical core concepts with Program & Project Managers
  5. Works with Terminology Team to develop needed new terms within the project timeline
  6. Collaborates on development and review of TA education materials to ensure accuracy and completeness
ADaM SME
TAPSC/TLCReceives Project Charter(TAs) for approval to proceed with the next stage of the development process.

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
1.0EVS Terminology Expert / Clinical TA Expert (s)

Gathers CRFs.

Review public databases, regulatory guidelines.

2.0Clinical TA Expert(s)

Refine scope.

Identify network for clinical SMEs.

3.0Project ManagerReview scoping materials.
4.0

Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert

Performs initial gap analysis.
5.0ADaM SMEHolds ADaM assessment meeting if applicable.
6.0Project ManagerDraft project charter and project plan.
7.0Project ManagerReview entire scope package with Data Science representative including the expected required Wiki structures.
8.0Project Manager

Submit scoping package to TAPSC/TLC.

Plans kick-off activities.

9.0TAPSC/TLCReceives Project Charters(TAs) for approval to proceed with the next stage of the development process.

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

References

List references pertinent to this Work Instruction, e.g., COP-001.

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