FDA Publishes ICH E8(R1) Guidance
13 April 2022 by CITI Program

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…

FDA Unannounced Inspections Program Resumes in India
13 April 2022 by CITI Program

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 – April 12, 2022
12 April 2022 by CITI Program

“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,…

CITI Program’s April 2022 Media Playlist – Part 1
12 April 2022 by CITI Program

CITI Program’s media playlists highlight content curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for…

OHRP Announces New Guidance on Informed Consent Posting
12 April 2022 by CITI Program

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…

NLM Updates the Clinicaltrials.gov FAQs
11 April 2022 by CITI Program

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…

HHS Seeks Comments on HITECH Act Requirements
7 April 2022 by CITI Program

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…

New NIH Website on Scientific Data Sharing
7 April 2022 by CITI Program

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 – April 5, 2022
5 April 2022 by CITI Program

“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,…

Learn About and Celebrate National Public Health Week 2022
5 April 2022 by CITI Program

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 – Modern Day Concerns and Training
7 March 2022 by CITI Program

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 – March 29, 2022
29 March 2022 by CITI Program

“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,…