Module 2.1 — CTD Table of Contents (TILA-278)

Document ID: M21
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4

2.1 CTD Table of Contents

This application comprises the Module 2–5 documents listed below. Module 1 regional administrative content is indexed in the regional Module 1 submission; the Trial Master File, program-management, and quality-system records are maintained outside the eCTD.

Module 2 — CTD Summaries

Module 2.2 — Introduction (TILA-278)
Module 2.3 — Quality Overall Summary (TILA-278)
Module 2.4 — Nonclinical Overview (TILA-278)
Module 2.5 — Clinical Overview
Module 2.5.6 — Benefit–Risk Assessment (TILA-278)
Module 2.6 — Nonclinical Written & Tabulated Summaries (TILA-278)
Module 2.7.1 — Summary of Biopharmaceutic Studies (TILA-278)
Module 2.7.2 — Summary of Clinical Pharmacology Studies (TILA-278)
Module 2.7.3 — Summary of Clinical Efficacy
Module 2.7.4 — Summary of Clinical Safety

Module 3 — Quality

Module 3 — Control Strategy & Specifications (TILA-278)
Module 3 — Stability Summary (TILA-278)
Module 3.2.P — Drug Product (TILA-278)
Module 3.2.S — Drug Substance (TILA-278)

Module 4 — Nonclinical Study Reports

Module 4.2.1 — Pharmacology Study Reports (TILA-278)
Module 4.2.2 — Pharmacokinetic Study Reports (TILA-278)
Module 4.2.3 — Toxicology Study Reports (TILA-278)

Module 5 — Clinical Study Reports

CDISC Conformance Validation Report — TILA278-201
Clinical Pharmacology — Human Pharmacokinetic Study Report (TILA-278)
Clinical Study Report Synopsis
Immunogenicity Summary Report (TILA-278)
Investigator's Brochure (TILA-278)
Protocol Synopsis
Statistical Analysis Plan (TILA-278)