The FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies,” to assist those that design clinical studies by outlining the internationally accepted…
The FDA has published the guidance document, “E8(R1) General Considerations for Clinical Studies,” to assist those that design clinical studies by outlining the internationally accepted…
The U.S. Food and Drug Administration (FDA) has resumed its unannounced foreign inspections program in India, yet it remains paused in China due to COVID-19…
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,…
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The Office for Human Research Protections (OHRP) recently released the guidance, “General Instructions on the Informed Consent Posting Requirement (45 CFR 46.116(h)).” The first of…
The U.S. National Library of Medicine has updated the Clinicaltrials.gov FAQs to address expanded access and all-cause mortality. The expanded access FAQs cover: What is…
The Office for Civil Rights (OCR) at the United States Department of Health and Human Services is seeking public input on recognized security practices as…
As a guest blogger for the NIH’s Under the Periscope blog, Dr. Mike Lauer, the NIH Deputy Director for Extramural Research, has introduced the NIH’s…
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,…
Every year, the American Public Health Association organizes National Public Health Week (NPHW) not only to recognize contributions to public health, but to address important…
Scholarly publishing, or academic publishing, is a form of publishing where researchers distribute their academic research and professional scholarship in academic journals, articles, books, and…
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare,…