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International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects to ensure that the rights, safety and wellbeing of the trial subjects are protected. Ensure the credibility of clinical trial data.

TABLE OF CONTENTS

INTRODUCTION TO ICH GCP 

1. GLOSSARY 

2. THE PRINCIPLES OF ICH GCP 

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

4. INVESTIGATOR 

5. SPONSOR 

6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) 

7. INVESTIGATOR’S BROCHURE 

8. Penny Black 40-174 Winter Illumination Cling Rubber Stamp

Clinical Research News

Upcoming Clinical Trials

Recent CRA jobs

  • Regulatory & Start-Up Specialist, (Germany, Homebased) - IQVIA MedTech

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  • Line Manager Within Project Services, Will be Remote based in UK

  • Boys Girls Cushioned Crew Socks, Athletic Hiking Socks, Compre
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  • Real World Solutions – Offering Management – Fall & Spring Intern

  • Sr. Director, IT – Finance Systems

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