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
Prerequisites
...
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 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 |
|---|---|
CRFs | Case Report Forms. |
| EVS | NCI Enterprise Vocabulary Services. |
| SMEs | Subject Matter Experts. |
TAPSC | CFAST Therapeutic Area Program Steering Committee. |
| TLC | Technical Leadership Committee. |
| 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). ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). |
| ADaM SME | Analysis Data Model Subject Matter Expert. |
| SRC | |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
| Project Manager |
Prepares the scoping package for submission.
Once the Project Charter is approved, Project Manager posts it in the team space on the CDISC Wiki.
Ensures the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking.
Completes the literature review for the therapeutic area and working with the Project Manager and the ADaM Representative to compile a reference list.
| |
| Technical Writer |
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| 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 | EVS Terminology Expert / Clinical TA Expert (s) | Technical Writer | Posts Draft standards for internal review. | ||
| 1.1 | Project Manager | Notifies targeted reviewers that Internal Review Stage has begun | Reviews public databases, regulatory guidelines. | ||
| 2.0 | Clinical TA Expert(s) | Refines scope. Identifies network for clinical SMEs. | Project Manager | Conducts Internal Review webinar | |
| 3.0 | SHARE Metadata Curator | Loads Internal Review version of draft standard into SHARE. | |||
| 43.0 | Project Manager | Reviews scoping materialsResolves comments and update draft standard with Medical Writer. | |||
| 45.0 | Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert | Performs initial gap analysis. | |||
| 5.0 | ADaM SME | Holds ADaM assessment meeting if applicable. | |||
| Project Manager | Reflects on feedback received to consider other perspectives. | ||||
| 6.0 | Project Team | Considers/defines conformance rules. | |||
| 76.0 | Project Manager | Drafts project charter and project plan. | Submits additionally terminology request as needed. | ||
| 8.0 | Project Team / Technical Writer | Performs peer review and prepare public review package. | |||
| 97.0 | Project Manager | Submit scoping package to TAPSC/TLC. Plans kick-off activities. | 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 | 7.1 | TAPSC/TLC | Receives Project Charters(TAs) for approval to proceed with the next stage of the development process. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.