(GCP-3) Selected FDA-issued Guidances and Guidelines Around Conducting Clinical Trials

Essential Regulations and Guidances for US-Based Clinical Research Site and IRB Personnel

Selected International Guidelines Around Clinical Trial Ethics

The Belmont Report
The Nuremburg Code
The WMA Declaration of Helsinki (October 2013)

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(GCP-1) Good Clinical Practice (GCP) for Drug and Biologic Clinical Trials Conducted for FDA Consideration

(GCP-2) Good Clinical Practice (GCP) for Medical Device Clinical Trials Conducted for FDA Consideration

(GCP-3) Essential Regulations and Guidances for US-Based Clinical Research Site and IRB Personnel

(GCP-4) Conducting Pharmaceutical and Medical Device Clinical Research in the European Union (EU)

(GMP-1) Current Good Manufacturing Practice (cGMP) for FDA-Regulated Drug and Biologic Products Manufactured in the United States.

(GLP-1) Good Laboratory Practice (GLP) for Drug and Biologic Nonclinical and Preclinical Trials Conducted for FDA Consideration

(DGW-1) The Plain English Glossary of International GXP Terms & AcronymsTrials

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