read-submission-readiness

name	read-submission-readiness
description	Read documentation completeness, data quality, and eCTD structure throughout the trial so the filing isn't a final-month scramble. Reach for this before a milestone.

Skill: Read submission readiness

The submission is built across the trial, not at the end.

Step 1 — Inventory the documentation

What's complete vs outstanding across the eCTD modules (§3 #7).

Step 2 — Check data quality

Query rate, missing data, and lock-readiness.

Step 3 — Structure the eCTD

Organize the documentation into the submission structure.

Step 4 — Flag the gaps

Surface readiness gaps as decision-support for the regulatory lead.

Output

A documentation inventory, a data-quality read, an eCTD structure, and the readiness gaps.