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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
SDTM

Study Data Tabulation Model.

Provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. 

CDASH

 Clinical Data Acquisition Standards Harmonization. 

Establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM).

ADaM

Analysis Data Model. 

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

SRC

Standards Review Council

The SRC is composed of experienced CDISC standards experts who review and approve all draft standards prior to publication and posting on the CDISC website. SRC Membership is rotated and through invitation from the CDISC CTO.

FDA

Food and Drug Administration

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products,

GGG 

Global Governance Group

SHAREGGG (Global Governance Group)

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.

Roles & Responsibilities

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

  • Works with the Project Manager to produce course materials, schedule public webinar to coincide with the commencement of the public review period and records webinar to be used as a resource for developing training material
  • Supports the finalization of the course materials
    • Makes the training materials available as close to publication of the new standard as possible
    RoleResponsibilities
    Project Manager
  • Works with the Education Team to schedule a public webinar to coincide with the commencement of the public review period
    • Notifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed
    1. Responds to Public Review comments and update the draft document
    2. Submits draft standard posting package to publication committee
    3. Submits additional terminology requests and complete other required activities as necessary (QRS)
    4. Sends final document to copy editor for review
    5. Submits provisional/final version with resolved comments to SRC
    6. Resolves issues noted by SRC
    		Education Team
    1. Responds to FDA comments and update the draft document
    2. Publishes material ready for GGG
    Technical writer
    1. Posts draft standard package for public review
    Copy Editor
    1.  Reviews the draft standard by a Copy-editor as a quality check right before Publication
    GGG
    1. Meets for publication approval
    2. Signs off for publication approval
    		GGG
    1. Reviews responses to Public Review comments. 
    2. Reviews and approved any normative content changes. 
    SRC
    1. Reviews provisional/final version with resolved comments
    2. Reviews and approves package for public release
    FDA
    1. Reviews the standard

    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

    1.0
    Education TeamWorks with the Project Manager to produce course materials2.0Project ManagerWorks with the Education Team to schedule a public webinar to coincide with the commencement of the public review period3.0Project ManagerNotifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed. 4.0Education TeamRecords the webinar to be used as a resource for developing training material. 5.0Project ManagerFinalizes a set of slides using the Education Webinar Presentation Template6.0Technical WriterPosts draft standard package for public review (New Term Request Spreadsheet)
    Publications TeamPosts draft standard package for public review Post for Public Review (website, Wiki, Library)



    		Public Review (PR) - Supposed to be 60 days (QRS Supplement = 30 days) 
    2
    7
    .0Project ManagerResponds to Public Review comments and update the draft documentPR comment resolution
    8

    3.0
    GGG
    FDAReviews
    responses to Public Review comments
    the standardFDA reviewFDA reviews some, not all, stds, sometimes FDA needs more time, especially for IG we have to allow time for review 
    4
    9.0Project ManagerCreates a list of issues for V210
    .0Project Manager
    Submits draft standard posting package to publication committee11.0GGGReviews and approved any normative content changes12.0Education Sub-Team Lead/Project ManagerCoordinate final approval of the training materials after all public review comments have been addressed and changes are reflected in the training materials13.0

    Education Team

    Supports the finalization of the course materials14.0Education TeamMakes the training materials available as close to publication of the new standard as possible15
    Responds to FDA comments and update the draft documentFDA comment resolution
    5.0Project Manager
    Submits additional terminology requests and complete other required activities as necessary (QRS)
    Publishes material ready for GGGPub material ready for GGG
    6.0Heads of stdsMeets for publication approval

    GGG meeting for Pub approval


    7.0Project ManagerSigns off for publication approvalGGG sign-off for publication (pub) approval
    16.0Project ManagerSends final document to copy editor for review17.0Project ManagerSubmits provisional/final version with resolved comments to SRC18.0SRCReviews provisional/final version with resolved comments19.0Project Manager Resolves issues noted by SRC20.0SRCReviews and approves package for public release21.0Copy Editor Reviews the draft standard as a quality check right before Publication22.0Submits public posting package to Publication Committee for preparation for publication

    General Workflow

    Include a general workflow diagram that summarizes this Work Instruction.

    ...