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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
GGG

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

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.

Roles & Responsibilities

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

RoleResponsibilities
Project Manager
  1. Resolves team review issues after Standards Team meets to review the standard prior to GGG
  2. Notifies the targeted reviewers when the Internal Review Stage has begun
  3. Conducts Internal Review webinar
  4. Ensures all comments requiring action are assigned and addressed
  5. Reflects on feedback received to consider other perspectives
  6. Submits additionally terminology request as needed
  7. Performs peer review and prepare public review package
  8. Submits public review package to SRC for approval
Technical Writer
  1. Posts Draft standards for internal review
  2. Performs peer review and prepare public review packageResolves comments and update draft standard with
Project ManagerProject Team
  1. Considers/defines conformance rules.
  2. Performs peer review and prepare public review package with Technical Writer
SHARE Metadata Curator
  1. Loads Internal Review version of draft standard into SHARE
Copy Editor
  1. Posts Internal Review copy-editing/c-e resolution
GGG
  1. Meets for internal and Public Review approval
  2. Signs off for Public Review Approval
SRC
  1. Gives feedback for the draft standard
  2. Approves draft standard for public review

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
1.0Technical WriterPosts Draft standards for internal review.Standards TeamReviews the standard prior to GGG1.1Project ManagerNotifies targeted reviewers that Internal Review Stage has begun.
2.0Project ManagerConducts Internal Review webinarResolves team review issues
3.0SHARE Metadata CuratorGGGMeets for Internal Review approvalLoads Internal Review version of draft standard into SHARE.
4.0Project ManagerTechnical WriterPosts Draft standards for internal reviewResolves comments and update draft standard with Medical Writer.
5.0Project ManagerReflects on feedback received to consider other perspectivesNotifies targeted reviewers that Internal Review Stage has begun.
6.0Project TeamManagerResolves comments and updates draft standardConsiders/defines conformance rules.
7.0Project ManagerCopy EditorPosts Internal Review copy-editing/c-e resolutionSubmits additionally terminology request as needed.
8.0Project Team / Technical WriterGGG

Meets for Public Review approval

Performs peer review and prepare public review package.

9.0Project Manager Submits public review package to SRC for approval.
10.0SRCGives feedback
11.0Project ManagerResolves issues noted by SRC.
GGGSigns off for Public Review Approval12.0SRCApproves Draft Standard 

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

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