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Purpose

The purpose of this stage is to develop an approach for meeting the initial requirements and define in more detail the information that will comprise the proposed new or enhanced standard, including comparisons to existing standards.

Scope

The deliverable for Stage 1 is a list of biomedical concepts, and other relevant artifacts, such as concept maps or terminology requests.

Prerequisites

Requirements assessment, project charter and the scoping package.

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
TLC Review Team

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.

QRS

Questionnaires, Ratings, and Scales.
SDSSubmission Domain Standard.
CDISC foundational standardsCDISC Foundational Standards are the basis for the complete CDISC suite of standards, supporting the clinical and non-clinical research process from protocol through data collection, data exchange, data management, data analysis, and reporting. These standards focus on the core principles for defining research data standards applicable to most research studies and include models, domains, and specifications for data representation.
Global Governance Group (GGG)Responsible for reviewing and approving all draft standards. This group is composed of representatives from each of the foundational teams who have been empowered to review and approve modeling decisions on behalf of their team. The GGG meetings are open to any CDISC team member.
CDISC JIRA issue trackerJira is a software created by Atlassian for tracking bugs and issues.  It is used by the CDISC Library Support Technician ("Support Technician") and the Azure Active Directory Administrator ("Azure Admin") to track CDISC Library accounts.

Roles & Responsibilities

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

RoleResponsibilities
Project Manager
  1. Assembles project team
  2. Sign up for the GGG review using GGG Signup sheet
  3. Submits all examples to the Global Governance Group (GGG) for approval
  4. Updates the project plan and project charter, and notifies all parties involved. Performs CDISC project review
Technical Writer
  1. Sets Up standard space in the wiki
QRS Representative.
  1. Performs inputs process, checking existing Questionnaires, Rating and Scales Supplements
  2. Reviews initial list of inputs produced with the team
  3. Ensures questionnaires are mapped to SDTM
  4. Works with Terminology Team to develop needed new terms
  5. Develops QRS supplements, as appropriate
  6. Checks copyright restrictions and resolves them, if possible
Clinical TA Expert
  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
SDTM Expert
  1. Completes the gap analysis on SDTM mappings
  2. Ensures proposed standards are aligned with SDTM
  3. Works with the Project Team to address areas not covered by the current SDTMIG
Global Governance Group (GGG)
  1. Receives, reviews, gives feedback, and approve modeling examples
  2.  Approves the modeling before the team can move to Stage 2
Metadata Developer
  1. Models concepts and creates concept maps
  2. Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert
  3. Refines deliverable plan

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
1.0Project TeamReviews of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions.
2.0QRS RepresentativeExpands the initial gap analysis, identifies questionnaires that are needed, and initiates the process for acquiring permissions. 
3.0QRS Representative / Clinical ExpertReviews the list of instruments and identifies those that need development.
4.0Metadata DeveloperModels Concepts
5.0Metadata Developer (Concept Developer)Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert.
6.0Clinical ExpertEvaluates new and different research concepts to ensure the data are clearly understood.
7.0Metadata DeveloperCreates concept maps
8.0SDTM Expert / SDS TeamWorks with the Project Team to address areas not covered by the current SDTMIG.
9.0Metadata DeveloperRefines Deliverable Plan. 
10.0Clinical Expert / Clinical SMEsEnsures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing.
11.0Project TeamRefines the concept maps and list of concepts as necessary.
12.0Project Manager

Submits all examples to the Global Governance Group (GGG) for approval. 

13.0Project TeamRefines the examples based on GGG feedback.
14.0GGG (Global Governance Group)Approves the modeling before the team can move to stage 2
15.0Project ManagerUpdates the project plan and project charter, and notifies all parties involved. Performs CDISC project review.


General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

References

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