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
The goal of the internal review is to affirm the following:
- Core concepts and definitions reuse prior work and have been properly represented in the standard
- Modeling is logically consistent both internally and with other CDISC standards
- New domains and variables are aligned with existing CDISC standards
- Documents conform to CDISC quality standards
Prerequisites
The 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
...
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 |
| |
| Technical WriterCDISC IT | Medical Writer |
|
| SHARE Metadata Curator | Loads Internal Review version of draft standard into SHARE. | |
|
| |
| SRC |
| |
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 ITTechnical Writer | 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 ManagerTeam | Considers/defines conformance rules. |
| 7.0 | Project Manager | Submits additionally terminology request as needed. |
| 8.0 | Project ManagerTeam / Technical Writer | Performs peer review and prepare public review package. |
| 9.0 | Project Manager | Submits public review package to SRC for approval. |
| 10.0 | SRC | Gives feedback |
| 11.0 | Project Manager | Resolves issues noted by SRC. |
| 12.0 | SRC | Approves Draft Standard |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.