Purpose
Ensure that the project is well defined with clear and achievable requirements and goals
Scope
Information collected is summarized in the Project Charter (TAs) that is submitted to the Team Leads/TAPSC for approval to proceed with the next stage of the development process..
Prerequisites
Indicates 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 | |
| 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 | |
| Project Team | |
| Clinical TA Expert(s) | |
| EVS Terminology Expert | |
| ADaM SME | |
| Program Manager | |
| TAPSC/TLC |
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 / Statical Analysis Expert | Performs initial gap analysis. |
| 5.0 | ADaM SME | Holds ADaM assessment meeting if aplicable |
| 6.0 | ||
| 7.0 |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.