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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 Manager
Project 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 #Responsible RoleInstructions
1.0Technical WriterPosts Draft standards for internal review.1.1Project ManagerNotifies targeted reviewers that Internal Review Stage has begun.2.0Project ManagerConducts Internal Review webinar3.0SHARE Metadata CuratorLoads Internal Review version of draft standard into SHARE.




Project ManagerReviews the standard prior to GGGTeam review prior to GGGTeam Review before GGG

Project ManagerResolves team review issuesResolution of team review issuesResolution of team review issues

Project Manager
IR Material ready for GGGPrepare for GGG Internal Review (IR)

Heads of Stds DevMeets for Internal Review approvalGGG meeting for IR approvalGGG meeting for IR approval

Project Manager
Internal Review (IR)Internal Review (IR)
4.0


Project ManagerResolves comments and
update
updates draft standard
with Medical Writer
.
5.0Project ManagerReflects on feedback received to consider other perspectives.6.0Project TeamConsiders/defines conformance rules.7.0Project ManagerSubmits additionally terminology request as needed.8.0Project Team / Technical WriterPerforms peer review and prepare public review package.9.0Project Manager Submits public review package to SRC for approval.10.0SRCGives feedback11.0Project ManagerResolves issues noted by SRC.12.0SRCApproves Draft Standard 
IR comment resolutionIR comment resolution

Copy EditorPosts Internal Review copy-editing/c-e resolutionPost-IR copy-editing/c-e resolutionPre-public review copy editing

Questions

Can this be in Jira?

Can questions/comments be during IR?

normal edits = 2-4+ weeks


Project Manager
PR Material ready for GGGPrepare for GGG Public Review (PR)

GGG

Meets for Public Review approval

GGG meeting for PR approvalGGG meeting for PR approval

GGG Reps.Signs off for Public Review Approval
Sign-off for Public Review Approval

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

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