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.

Scope

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.

TermDefinition
SDTM

Study Data Tabulation Model.

Provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. 

CDASH

 Clinical Data Acquisition Standards Harmonization. 

Establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM).

ADaM

Analysis Data Model. 

ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, an traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).​

SRC
SHARE
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. Works with the Education Team to schedule a public webinar to coincide with the commencement of the public review period
  2. Notifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed
  3. Responds to Public Review comments and update the draft document
  4. Submits draft standard posting package to publication committee
  5. Submits additional terminology requests and complete other required activities as necessary (QRS)
  6. Sends final document to copy editor for review
  7. Submits provisional/final version with resolved comments to SRC
  8. Resolves issues noted by SRC
Education Team
  1. Works with the Project Manager to produce course materials, schedule public webinar to coincide with the commencement of the public review period and records webinar to be used as a resource for developing training material
  2. Supports the finalization of the course materials
  3. Makes the training materials available as close to publication of the new standard as possible
Technical writer
  1. Posts draft standard package for public review
Copy Editor
  1.  Reviews the draft standard by a Copy-editor as a quality check right before Publication
GGG
  1. Reviews responses to Public Review comments. 
  2. Reviews and approved any normative content changes. 
SRC
  1. Reviews provisional/final version with resolved comments
  2. Reviews and approves package for public release


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
1.0Education TeamWorks with the Project Manager to produce course materials
2.0Project ManagerWorks with the Education Team to schedule a public webinar to coincide with the commencement of the public review period
3.0Project ManagerNotifies the Education Team of the planned public review posting dates and verifies that the presentation slides are developed. 
4.0Education TeamRecords the webinar to be used as a resource for developing training material. 
5.0Project ManagerFinalizes a set of slides using the Education Webinar Presentation Template
6.0Technical WriterPosts draft standard package for public review (New Term Request Spreadsheet)
7.0Project ManagerResponds to Public Review comments and update the draft document
8.0GGGReviews responses to Public Review comments
9.0Project ManagerCreates a list of issues for V2
10.0Project ManagerSubmits draft standard posting package to publication committee
11.0GGGReviews and approved any normative content changes
12.0Education Sub-Team Lead/Project ManagerCoordinate 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
14.0Education TeamMakes the training materials available as close to publication of the new standard as possible
15.0Project ManagerSubmits additional terminology requests and complete other required activities as necessary (QRS)
16.0Project ManagerSends final document to copy editor for review
17.0Project ManagerSubmits provisional/final version with resolved comments to SRC
18.0SRCReviews provisional/final version with resolved comments
19.0Project Manager Resolves issues noted by SRC
20.0SRCReviews and approves package for public release
21.0Copy 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

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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