CDISC SOP Gap & Risk Review

I have five existing CDISC-related SOPs—the SDTM, ADaM, and TLFs procedures together with their overarching Workflow and Governance documents—and I need a systematic quality-control pass on all of them. The priority isn't stylistic polishing; I want a sharp eye that surfaces missing process steps, hidden risk points, or areas where ownership and hand-offs are vague.

You’ll work directly in the Word originals (track changes on) or supply clearly cross-referenced comments if you prefer a separate review sheet. For each SOP, call out:

• Steps that are implied but never written
• Risky transitions or dependencies that lack controls
• Roles or responsibilities that are ambiguous or absent
• Any conflicts between the individual SOPs and the Governance document

Please finish with a concise gap-analysis summary and, where it helps, a simple RACI chart so I can see responsibility splits at a glance.

No rewriting is needed beyond the notes; I’ll handle edits once the gaps are visible.

The reviewer must have a high-level qualification in Biostatistics or Statistical Programming, CDSIC qualification certificates, and at least 3 years' experience working with CDISC standards and their implementation. I need to see all evidence of the qualifications and proven experience. I don’t accept any AI-generated work. The work must be genuine and professional, based on your knowledge and experience.

I will not pay for work if these conditions are breached.