Purpose
State the purpose of this Work Instruction.
Scope
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.Provide the scope for this Work Instruction.
Prerequisites
Indicates if any pre-requisite(s) prior to carrying out this Work Instruction. Put "Not applicable." if this section is not applicable.
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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 | CDISC Library API Architect | Design API specification in OAS3 format in team workspace hosted by Swaggerhub. | |||
| 1.1 | CDISC Library API Architect | Inform CDISC Library Software Developer when API specification is ready for implementation. | |||
| 2.0 | CDISC Library Software Developer | Implement API endpoints based on the API specification. | |||
| 2.1 | CDISC Library Software Developer | Make update suggestions where applicable. | |||
| 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 | 3.0 | CDISC Library Software Developer | Deploy software code to the development environment. |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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