Blog

On Campus with CITI Program Podcast: Recap of Episodes 1-7

“On Campus with CITI Program” is a biweekly podcast launched in January 2022 and hosted by Darren Gaddis, Assistant Director of Content and Education at...

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OLAW Requests Input on Flexibilities Available to IACUCs for Program Review

The NIH Office of Laboratory Animal Welfare (OLAW) is seeking public input on flexibilities that IACUCs may consider when conducting semiannual program reviews as a...

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What CITI Program is Reading – April 19, 2022

“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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FDA Releases Draft Guidance on the Approach for Developing a Race and Ethnicity Diversity Plan

The FDA has released a draft guidance document, “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft...

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FDA Publishes ICH E8(R1) Guidance

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...

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FDA Unannounced Inspections Program Resumes in India

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...

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What CITI Program is Reading – April 12, 2022

“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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CITI Program’s April 2022 Media Playlist – Part 1

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...

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OHRP Announces New Guidance on Informed Consent Posting

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...

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NLM Updates the Clinicaltrials.gov FAQs

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...

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