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Purpose

The purpose of the Internal Review is to ensure that all CDISC teams, collaborative groups and subject matter experts impacted by the draft standards have the opportunity to review the draft standard prior to Public Review.

Scope

The goal of the internal review is to affirm the following:

  • Core concepts and definitions reuse prior work and have been properly represented in the standard
  • Modeling is logically consistent both internally and with other CDISC standards
  • New domains and variables are aligned with existing CDISC standards
  • Documents conform to CDISC quality standards

Prerequisites

The draft standard should include the following elements:

  • Concept maps for key clinical concepts
  • Metadata displays
  • SDTM, CDASH and ADaM models or examples, as appropriate

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
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.

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
Technical Writer
  1. Posts Draft standards for internal review
  2. Performs peer review and prepare public review package
Project Team
  1. Considers/defines conformance rules.
  2. Performs peer review and prepare public review package with Technical Writer
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

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
1.0Standards TeamReviews the standard prior to GGG
2.0Project ManagerResolves team review issues
3.0GGGMeets for Internal Review approval
4.0Technical WriterPosts Draft standards for internal review.
5.0Project ManagerNotifies targeted reviewers that Internal Review Stage has begun.
6.0Project ManagerResolves comments and updates draft standard.
7.0Copy EditorPosts Internal Review copy-editing/c-e resolution
8.0GGG

Meets for Public Review approval

9.0GGGSigns off for Public Review Approval

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

References

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

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