Purpose
Build on the draft list of biomedical concepts or content developed in Stage 1 and develop examples and metadata to enhance and finalize concepts
Scope
At the end of this stage, the draft document should be completed and contain all needed components in order to enable a thorough Internal Review.
Prerequisites
Biomedical concepts, and other relevant artifacts, such as concept maps o terminology requests.
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 | |
| SMEs | |
TAPSC/TLC | |
| ADaM | Analysis Data Model |
| ADaM SME |
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. |
| Project Team | |
| Clinical TA Expert(s) | 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. |
| EVS Terminology Expert | |
| ADaM SME | |
| TAPSC/TLC | Receives Project Charter(TAs) for approval to proceed with the next stage of the development process. |
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) | Gathers CRFs. Reviews public databases, regulatory guidelines. |
| 2.0 | Clinical TA Expert(s) | Refines scope. Identifies network for clinical SMEs. |
| 3.0 | Project Manager | Reviews scoping materials. |
| 4.0 | Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert | Performs initial gap analysis. |
| 5.0 | ADaM SME | Holds ADaM assessment meeting if applicable. |
| 6.0 | Project Manager | Drafts project charter and project plan. |
| 7.0 | Project Manager | Submit scoping package to TAPSC/TLC. Plans kick-off activities. |
| 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.