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| 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 | 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.
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| Step # | Role | Instructions |
|---|---|---|
| 1.0 | Technical Writer | Posts draft standard package for public review (New Term Request Spreadsheet) |
| 2.0 | Project Manager | Responds to Public Review comments and update the draft document |
| 3.0 | FDA | Reviews the standard |
| 4.0 | Project Manager | Responds to FDA comments and update the draft document |
| 5.0 | Project Manager | Publishes material ready for GGG |
| 6.0 | GGG | Meets for publication approval |
| 7.0 | GGG | Signs off for publication approval |
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