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 |
|---|---|
| SDTM | |
| CDASH | |
| ADaM | |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
| Role | Responsibilities |
|---|---|
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 | ||
| 2.0 | ||
| 3.0 | ||
| 4.0 | ||
| 5.0 | ||
| 6.0 | ||
| 7.0 | ||
| 7.1 |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.