Regfo
Module 5clinicalnda● High priority

5.2 — Tabular Listing of All Clinical Studies

Tabular listing of all clinical studies including study number, phase, design, population, treatments, and status

Requirements by Phase

Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required

Tabular listing of all clinical studies including study number, phase, design, population, treatments, and status

Requirements by Phase

NDA: required

Content Requirements

  • Complete table of all clinical studies
  • Study number, design, dose, population, duration, status
  • Report location within the CTD
  • Phase designation and study objectives

Expected Deliverables

  • Tabular listing of all clinical studies (PDF)

ICH Guidelines: M4E(R2)

Source: ICH M4E; ICH E3

References

ICH M4EICH E3

Related Sections

Up toModule 5: Clinical Study Reports
5.3 — Clinical Study Reports

Clinical study reports organized by biopharmaceutics, human biomaterials, PK, PD, efficacy/safety, post-marketing

5.4 — Literature References (Clinical)

Published literature references supporting clinical development program

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