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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.

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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.

TermDefinition

CRFs

Case Report Forms
EVSSMEs

TAPSC/TLC

ADaMAnalysis Data Model
ADaM SME
SDTM
CDASH
ADaM






Roles & Responsibilities

Lists all roles and their responsibilities relevant to this Work Instruction.

EVS Terminology Expert
RoleResponsibilities
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.

ADaM SME
TAPSC/TLCReceives 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 #RoleInstructions
1.0EVS Terminology Expert / Clinical TA Expert (s)

Gathers CRFs.

Reviews public databases, regulatory guidelines.



2.0Clinical TA Expert(s)

Refines scope.

Identifies network for clinical SMEs.


3.0Project ManagerReviews scoping materials.

4.0

Clinical TA Expert(s) / EVS Terminology Expert / Statistical Analysis Expert

Performs initial gap analysis.

5.0ADaM SMEHolds ADaM assessment meeting if applicable.

6.0Project ManagerDrafts project charter and project plan.

7.0Project Manager

Submit scoping package to TAPSC/TLC.

Plans kick-off activities.



7.1TAPSC/TLCReceives 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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