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.