CDISC Workflow & Governance Guide

I am formalising an end-to-end CDISC workflow document for my personal project and need a subject-matter expert who has actually lived through the process inside a contract research organisation. The goal is a single, well-structured document that maps every step—from first CRF draft to final submission package—and sets clear data-governance rules that our clinical, biometrics, and regulatory teams can adopt immediately.

Scope of the workflow
• Data Collection and Preparation: cover Case Report Form (CRF) design principles, Electronic Data Capture (EDC) configuration, and robust data-cleaning / validation checkpoints that align with CDASH and SDTM expectations.
• Data Analysis and Reporting: outline Statistical Analysis Plan (SAP) development flow, traceability rules for analysis-ready datasets (ADaM), and best practices for Tables, Listings, and Figures (TLF) generation in SAS.
• Data Submission and Archiving: describe creation of Define.xml, reviewer guides, Pinnacle 21 validation cycles, and long-term archive strategy.

Deliverables
1. CDISC Workflow & Data Governance document (Word and PDF) that walks through the three phases above, shows RACI ownership, and references tools/standards (SDTM, ADaM, CDASH, Pinnacle 21, SAS) where applicable.
2. A visual flowchart (Visio or PowerPoint) summarising key decision points and data hand-offs.
3. Brief implementation checklist we can use to audit new studies against the workflow.

Acceptance criteria
• Language is clear enough for non-statistical stakeholders yet precise on CDISC terminology.
• All steps reference current FDA/PMDA guidance and CDISC v1.4 standards or later.
• Document withstands a mock submission readiness review without major rework.

I will supply our existing SOPs and study templates once we start; your job is to integrate, streamline, and fill the gaps.