Purpose
The purpose of the Public Review is to develop widespread consensus for the proposed standard by allowing for broad comment by the general public.
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The deliverables are the standards document posting package, including electronic metadata as appropriate.
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.
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| Step # | Role | Instructions |
|---|---|---|
| 1.0 | Education Team | Works with the Project Manager to produce course materials |
| 2.0 | Project Manager | Works with the Education Team to schedule a public webinar to coincide with the commencement of the public review period |
| 3.0 | Project Manager | Notifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed. |
| 4.0 | Education Team | Records the webinar to be used as a resource for developing training material. |
| 5.0 | Project Manager | Finalizes a set of slides using the Education Webinar Presentation Template |
| 6.0 | Technical Writer | Posts draft standard package for public review (New Term Request Spreadsheet) |
| 7.0 | Project Manager | Responds to Public Review comments and update the draft document |
| 8.0 | GGG | Reviews responses to Public Review comments |
| 9.0 | Project Manager | Creates a list of issues for V2 |
| 10.0 | Project Manager | Submits draft standard posting package to publication committee |
| 11.0 | GGG | Reviews and approved any normative content changes |
| 12.0 | Education Sub-Team Lead/Project Manager | Coordinate final approval of the training materials after all public review comments have been addressed and changes are reflected in the training materials |
| 13.0 | Education Team | Supports the finalization of the course materials |
| 14.0 | Education Team | Makes the training materials available as close to publication of the new standard as possible |
| 15.0 | Project Manager | Submits additional terminology requests and complete other required activities as necessary (QRS) |
| 16.0 | Project Manager | Sends final document to copy editor for review |
| 17.0 | Project Manager | Submits provisional/final version with resolved comments to SRC |
| 18.0 | SRC | Reviews provisional/final version with resolved comments |
| 19.0 | Project Manager | Resolves issues noted by SRC |
| 20.0 | SRC | Reviews and approves package for public release |
| 21.0 | Copy Editor | Reviews the draft standard as a quality check right before Publication |
| 22.0 | Submits public posting package to Publication Committee for preparation for publication |
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