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

ICH E6(R3) Guideline

ICH H ARMONISED G UIDELINE

G UIDELINE FOR G OOD C LINICAL P RACTICE

E6(R3)

ICH Consensus Guideline

TABLE OF CONTENTS

I. INTRODUCTION ........................................................................................................ 1

Guideline Scope ......................................................................................................................... 1

Guideline Structure .................................................................................................................... 1

II. PRINCIPLES OF ICH GCP ....................................................................................... 2

III. ANNEX 1 ...................................................................................................................... 7

1.

INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) ........................................................................................... 7

1.1 Submission and Communication ...................................................................................8

1.2 Responsibilities .............................................................................................................. 8

1.3 Composition, Functions and Operations........................................................................9

1.4 Procedures .................................................................................................................... 10

1.5 Records ........................................................................................................................ 11

2. INVESTIGATOR ...................................................................................................... 11

2.1 Qualifications and Training .........................................................................................11

2.2 Resources ..................................................................................................................... 12

2.3 Responsibilities ............................................................................................................ 12

2.4 Communication with IRB/IEC ....................................................................................12

2.5 Compliance with Protocol............................................................................................13

2.6 Premature Termination or Suspension of a Trial .........................................................14

2.7 Participant Medical Care and Safety Reporting...........................................................14

2.7.1

Medical Care of Trial Participants ........................................................... 14

2.7.2

Safety Reporting ........................................................................................ 14

2.8 Informed Consent of Trial Participants........................................................................15

2.9 End of Participation in a Clinical Trial ........................................................................19

2.10 Investigational Product Management ..........................................................................20

2.11 Randomisation Procedures and Unblinding.................................................................21

2.12 Records ........................................................................................................................ 21

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