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.
| Term | Definition |
|---|---|
| FDA | Food and Drug Administration The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, |
| 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.
| Role | Responsibilities |
|---|---|
| Project Manager |
|
| Technical writer |
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| GGG |
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| SRC |
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| FDA |
|
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 # | Role | Instructions | ||
|---|---|---|---|---|
| 1.0 | Publications Team | Posts draft standard package for public review | Post for Public Review (website, Wiki, Library) | |
| Public Review (PR) | - Supposed to be 60 days (QRS Supplement = 30 days) | |||
| 2.0 | Project Manager | Responds to Public Review comments and update the draft document | PR comment resolution | |
| 3.0 | FDA | Reviews the standard | FDA review | FDA reviews some, not all, stds, sometimes FDA needs more time, especially for IG we have to allow time for review |
| 4.0 | Project Manager | Responds to FDA comments and update the draft document | FDA comment resolution | |
| 5.0 | Project Manager | Publishes material ready for GGG | Pub material ready for GGG | |
| 6.0 | Heads of stds | Meets for publication approval | GGG meeting for Pub approval | |
| 7.0 | Project Manager | Signs off for publication approval | GGG sign-off for publication (pub) 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.