Regfo
Module 5clinicalndaind

5.4 — Literature References (Clinical)

Published literature references supporting clinical development program

Requirements by Phase

Phase 1
optional
Phase 2
optional
Phase 3
optional
NDA
required

Published literature references supporting clinical development program

Requirements by Phase

IND Phase 1: optional IND Phase 2: optional IND Phase 3: optional NDA: required

Content Requirements

  • Published literature referenced in Module 5
  • Copies of key publications
  • Literature supporting clinical development rationale

Expected Deliverables

  • Compiled literature references (PDF copies)

ICH Guidelines: M4E(R2)

Source: ICH M4E

References

ICH M4E

Related Sections

Up toModule 5: Clinical Study Reports
5.2 — Tabular Listing of All Clinical Studies

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

5.3 — Clinical Study Reports

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

Check your compliance against this section

Upload your study data and get instant gap analysis with specific regulatory citations.

Try Compliance Check