ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

A.2.1

Title Page .................................................................................................. 53

A.2.2

Confidentiality Statement .......................................................................... 53

A.3 Contents of the Investigator’s Brochure ...................................................................... 53

A.3.1

Table of Contents ....................................................................................... 53

A.3.2

Summary .................................................................................................... 53

A.3.3

Introduction ............................................................................................... 53

A.3.4

Physical, Chemical and Pharmaceutical Properties and Formulation .... 54

A.3.5

Nonclinical Studies .................................................................................... 54

A.3.6

Effects in Humans ...................................................................................... 55

A.3.7

Summary of Data and Guidance ............................................................... 56

Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) ...................................................................................................................................... 58

B.1 General Information ..................................................................................................... 58

B.2 Background Information .............................................................................................. 58

B.3 Trial Objectives and Purpose .......................................................................................59

B.4 Trial Design ................................................................................................................. 59

B.5 Selection of Participants .............................................................................................. 60

B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial............60

B.7 Treatment and Interventions for Participants...............................................................60

B.8 Assessment of Efficacy ................................................................................................ 60

B.9 Assessment of Safety ...................................................................................................61

B.10 Statistical Considerations ............................................................................................. 61

B.11 Direct Access to Source Records .................................................................................61

B.12 Quality Control and Quality Assurance .......................................................................62

B.13 Ethics............................................................................................................................ 62

B.14 Data Handling and Record Keeping ............................................................................62

B.15 Financing and Insurance .............................................................................................. 62

B.16 Publication Policy ........................................................................................................ 62

Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL ......................................................................................................................... 63

C.1 Introduction .................................................................................................................. 63

C.2 Management of Essential Records...............................................................................63

C.3 Essentiality of Trial Records........................................................................................64

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