Subjects: Ethics Committees, Research and United States. Food and Drug Administration. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Ethics Committees, Research ✖ Subjects United States. Food and Drug Administration. ✖

1. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators

Publication:: [Silver Spring, MD] : Oncology Center of Excellence, June 2020
Subject(s):: Biological Products -- therapeutic use
COVID-19 -- drug therapy
Drugs, Investigational
Ethics Committees, Research
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, July 11, 2019
Subject(s):: Clinical Trials as Topic
Device Approval
Data Collection
Ethics Committees, Research
Informed Consent
Single-Case Studies as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.