E8(R1) general considerations for clinical studies
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Clinical Studies as Topic -- standards Clinical Trials as Topic -- standards United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance describes internationally accepted principles and practices in the design and conduct of clinical studies of drug and biological products. The guidance is intended to assist sponsors and other parties that design clinical studies, and to promote the quality of the studies submitted to regulatory authorities, while allowing for flexibility. This guidance revises the ICH guidance E8 General Considerations for Clinical Trials issued in December 1997. Significant changes from the 1997 version include the following: (1) addresses study quality to ensure the protection of study participants and the generation of reliable and meaningful results, while promoting study efficiency; (2) addresses a broad range of study designs and data sources; and (3) provides updated cross-referencing to other relevant ICH guidances that inform the design, planning, and conduct of clinical research. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 26 pages)).
- NLM Unique ID:
- 9918452387706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452387706676