Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.



Resolve public review comments

Stage 0

Scoping and Planning

Stage 1

Concept Modeling

Stage 2

Development of Draft

Stage 3a

Internal Review

Stage 3b

Public Review

Stage 3c

Publication

Review Process Document
Draft the standardResolve internal review comments
Collect remaining inputs and permissionsDefine metadata modeling approach for new biomedical concepts with modeling expertsPost draft standard for Internal ReviewCollect public review commentsCommunications Team posts the standard on www.cdisc.org


Review the GGG Governance Structure
Sign up for GGG Review Coordinate copy-editing
Model and develop biomedical conceptsDevelop detailed metadata or specifications for standard, as appropriatePerform fit for use testing (optional)

Respond to Public Review comments and update the draft document

Resolve public review comments

Communications Team announces availability of the new standard package
Complete publication documents
Request a Wiki Space and an accompanying JIRA projectReview concepts maps with clinical and/or relevant SMEs (if applicable)Develop data examples consistent with metadata, as appropriate

Resolve issues and update draft standard 

Resolve internal review comments

GGG reviews responses to Public Review comments



Perform background research and initial scoping

Refine information requirements

Develop draft standards document and review package

Draft the standard

Begin to develop education materials, including Public Review webinar (if needed)Any normative content changes need to be reviewed and approved by the GGG.
Complete internal review documentsComplete public review documents

Obtain approval from appropriate governance body for the scoping packageDevelop terminologies (including QRS)Review package against the QC checklistCoordinate copy-editingSubmit additional terminology
requests and complete other required activities as necessary (QRS)


Obtain approval from appropriate governance bodySign up for GGG Review Complete public review documentsSend final document to copy editor for review


Complete internal review documentsAny normative content changes need to be reviewed by the GGG for approval to post for Public ReviewComplete publication documents



• Obtain Global Governance Group (GGG) approval for Internal Review (excludes QRS)

Sign up for GGG Review

GGG reps sign off for internal review

 Sign up for GGG Review Sign up for GGG Review







• Finalize draft standards document and package for Internal ReviewGGG reps sign off for public review

GGG leads provide approval for publication

GGG reps sign off for

public review

publication





Submit public posting package to Publication CommitteeComplete publication checklist



Communications Team posts draft for Public ReviewFinal approval from Heads of Standards




Coordinate copy-editing
Lock space for Data Science Team Activities





Submit public posting package to Publication Committee for preparation for publication