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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
TA

Therapeutic Area.

The TA is an area of medical practice that encompasses groupings of specific diseases and/or disorders generally treated by a specific medical specialty, such as oncology, cardiovascular, neurology or hematology.

TAPSCTherapeutic Area Standards Program Steering Committee.

CRFs

Case Report Forms.

CRFs used to capture clinical trial data rely on linkages between and among concepts. CRFs also frequently contain logic, such as which values are allowed for a given field, when one field is a value calculated from other fields, and when some fields are not relevant based on an answer to another field.

EVS

National Cancer Institute (NCI) Enterprise Vocabulary Services.

EVS provides terminology content, tools, and services to meet the needs of NCI and the biomedical research community.

SMEs

Subject Matter Experts.

 SME is a person who possesses a deep understanding of a particular subject.

TLC

Technical 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).

Roles & Responsibilities

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

RoleResponsibilities
Project Manager
  1. 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.

  2. Prepares the scoping package for submission.

  3. Posts it in the team space on the CDISC Wiki once the Project Charter is approved.

Project Team
  1. Ensure applicable regulatory guidance and requirements are taken into account.
Clinical TA Expert(s)

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

  2. 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 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 stage and identifies potential areas that will require new constructs in ADaM
  2. Holds ADaM assessment meeting if applicable.
TAPSC/TLC
  1. Receives Project Charter(TAs) for approval to proceed with 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
1.0EVS Terminology Expert / Clinical TA Expert (s)

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

2.0Project TeamEnsure applicable regulatory guidance and requirements are taken into account.
2.1Clinical 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.
3.0Clinical TA Expert(s)

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

4.0Project ManagerReview scoping materials.
5.0

EVS Terminology Expert

Performs Controlled Terminology Gap Analysis.
6.0ADaM SMEHolds ADaM assessment meeting if applicable.
7.0Project ManagerDraft project charter and project plan.
8.0Project ManagerReview the entire scope package with the Data Science representative including the expected required Wiki structures.
9.0Project Manager

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

10.0TAPSC/TLC

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

11.0Project Manager

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

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

ScopingSwimLanes



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References

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



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