Submission Readiness

Regulatory Submission Readiness:

• Review and confirm clinical data adheres to CDISC data standards (e.g., SDTM, ADaM)

• Review statistical code and programming logic

• Oversee metadata management for data traceability

• Validate tables, figures, and listings (TFLs)

• Review related documents (e.g., blank CRF, Reviewer's Guides, Define-XML)