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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
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. Notifies the targeted reviewers when the Internal Review Stage has begun
  2. Conducts Internal Review webinar
  3. Ensures all comments requiring action are assigned and addressed
  4. Reflects on feedback received to consider other perspectives
  5. Submits additionally terminology request as needed
  6. Performs peer review and prepare public review package
  7. 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 package
  3. Resolves 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
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.
1.1Project ManagerNotifies targeted reviewers that Internal Review Stage has begun.
2.0Project ManagerConducts Internal Review webinar
3.0SHARE Metadata CuratorLoads Internal Review version of draft standard into SHARE.
4.0Project ManagerResolves comments and update 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 feedback
11.0Project ManagerResolves issues noted by SRC.
12.0SRCApproves Draft Standard 

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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