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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
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 ReviewIndicates if any pre-requisite(s) prior to carrying out this Work Instruction. Put "Not applicable." if this section is not applicable.
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). | ||
| SRC | |||
| SHARE | ADaM SME | Analysis Data Model Subject Matter Expert. | |
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.
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 | EVS Terminology Expert / Clinical TA Expert (s) | CDISC IT | 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 | Project Manager | SHARE Metadata Curator | Loads Internal Review version of draft standard into SHAREReviews scoping materials. | ||
| 4.0 | Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert | Project Manager | Resolves comments and update draft standard with Medical WriterPerforms initial gap analysis. | ||
| 5.0 | ADaM SME | Project Manager | Reflects on feedback received to consider other perspectivesHolds ADaM assessment meeting if applicable. | ||
| 6.0 | Project Manager | Drafts project charter and project planConsiders/defines conformance rules. | |||
| 7.0 | Project Manager | Submit scoping package to TAPSC/TLC. Plans kick-off activities. | 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 | 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.
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