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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.

Medical Research Council
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.MRC.
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. 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 materialsAssembles project team
  5. Sign up for the GGG review using GGG Signup sheet.
  6. Assembles project team
CDISC Education Representative

A member of the Education Team

  1. Coordinates development of draft and final training materials with Project Managers
  2. Orients the Project Team to the Education Team training development process and Presentation Templates
  3. Facilitates the production and recording of webinars
  4. Conducts an initial meeting to orient the Project Manager and team on training development procedures and templates.
  5. Supports the foundational education sub-team leads with process, tools and templates.
Foundational education sub-team leads

A member of the Foundational Standards team

  1. Creates and maintains on-line and classroom courses
  2. Oversees the qualification of new instructors
  3. Helps identify instructors to teach specific courses.
  4. Creates and maintain on-line and classroom courses.
  5. Oversee the qualification of new instructors. Helps identify instructors to teach specific courses
  2. Submits all examples to the Global Governance Group (GGG) for approval
  3. 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
  7. Expands the initial gap analysis, identifies questionnaires that are needed and initiates the process for acquiring permissions
    8. Reviews the list of instruments with the
Clinical Expert and identifies those that need developmentClinical 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
  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
  8. Assists with the communication between regulatory experts and project manager
  9. Reviews internal clinical check of concepts and concept maps. . 
SDTM Expert
  1. Reviews the output of the initial scoping and planning stage and identifies potential areas that will require new constructs in SDTM
  2. Completes the gap analysis on SDTM mappings
  3. Ensures proposed standards are aligned with SDTMCollaborates on the development and review of TA education materials to ensure accuracy and completeness, as needed
  4. Works with the Project Team to address areas not covered by the current SDTMIG
Global Governance Group (GGG)Reviews and approves standards prior to posting for internal review, public review and publication
  1. Ensures that all public review comments have been adequately addressed
  2. Reviews modeling issues that have been escalated for resolution from internal CDISC teams
  3. Receives, reviews, gives feedback, and approve modeling examples
  4.  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.

The Education Representative conducts an initial meeting to orient the Project Manager and team on training development procedures and templates. 
Step #RoleInstructions
1.0Project Manager

Assembles project team

2.0CDISC Education TeamAssigns an Education Representative to work with the project team.
3.0Education Representative
3.1Foundational education sub-team leadsCollaborates with CDISC education team for their respective foundational standards4.0Project TeamReviews of applicable questionnaires and scales used and initiates the process for collecting the required copyright permissions.
42.10QRS RepresentativeExpands the initial gap analysis, identifies questionnaires that are needed, and initiates the process for acquiring permissions. 
43.20QRS Representative / Clinical ExpertReviews the list of instruments and identifies those that need development.
54.0Technical WriterSets up standard space in the wiki.6.0Metadata DeveloperModels Concepts
65.10Metadata Developer (Concept Developer)Defines any concepts that have not been addressed in current CDISC standards to reach a common understanding with the Clinical Expert.
76.0Clinical ExpertEvaluates new and different research concepts to ensure the data are clearly understood.
87.0Metadata DeveloperCreates concept maps
98.0SDTM Expert / SDS TeamWorks with the Project Team to address areas not covered by the current SDTMIG.
109.0Metadata DeveloperRefines Deliverable Plan. 
1110.0Clinical Expert / Clinical SMEsEnsures the core concepts under development are adequate and appropriate, and that there are no significant concepts missing.
1211.0Project TeamRefines the concept maps and list of concepts as necessary.
1312.0Project Manager

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

13.10Project 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.