Purpose
The purpose of the Internal Review is to ensure that all CDISC teams, collaborative groups and subject matter experts impacted by the draft standards have the opportunity to review the draft standard prior to Public Review.
Scope
At the end of this stage, 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
Prerequisites
Draft standards review package containing examples and metadata of biomedical concepts or content developed in Stage 1.
The Internal Review Checklist must be complete and the Global Governance Group must approve the draft standard prior to posting for Internal Review.
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 |
|---|---|
| SRC | |
| SHARE | |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
| Project Manager | Notifies the targeted reviewers when the Internal Review Stage has begun. Conducts Internal Review webinar. Ensures all comments requiring action are assigned and addressed. |
| CDISC IT | Posts Draft standards for internal review. |
| SHARE Metadata Curator | Loads Internal Review version of draft standard into SHARE. |
| Medical Writer | Resolves comments and update draft standard with Project Manager. |
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 | CDISC IT | Posts Draft standards for internal review. |
| 1.1 | Project Manager | Notifies targeted reviewers that Internal Review Stage has begun. |
| 2.0 | Project Manager | Conducts Internal Review webinar |
| 3.0 | SHARE Metadata Curator | Loads Internal Review version of draft standard into SHARE. |
| 4.0 | Project Manager | Resolves comments and update draft standard with Medical Writer. |
| 5.0 | Project Manager | Reflects on feedback received to consider other perspectives. |
| 6.0 | Project Manager | Considers/defines conformance rules. |
| 7.0 | Project Manager | Submits additionally terminology request as needed. |
| 8.0 | Project Manager | Performs peer review and prepare public review package. |
| 9.0 | Project Manager | Submits public review package to SRC for approval. |
| 10.0 | Project Manager | Resolves issues noted by SRC. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.