2018 E6R2GoodClinicalPracticeIntegra

• (FDA et al., 2018) ⇒ U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). (2018). “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1).”

Subject Headings: Clinical Trial; Good Clinical Practice.

Notes

• It an FDA updated version of the ICH Harmonised Guideline: Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2), 2015.

Cited By

• Google Scholar: ~ 2+Citations.

Quotes

Abstract

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.

References

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	Author	volume	Date Value	title	type	journal	titleUrl	doi	note	year
2018 E6R2GoodClinicalPracticeIntegra	United States Food And Drug Administration (FDA) Center For Drug Evaluation and Research (CDER) Center For Biologics Evaluation and Research (CBER)			E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)