OSTP Releases Guidance on National Security for U.S. Government-Supported Research
7 January 2022 by CITI Program

On January 4, 2022, the White House Office of Science and Technology Policy (OSTP) released the report, “Guidance for Implementing National Security Presidential Memorandum 33…

FDA Releases Draft Guidance on Digital Health Technologies & Remote Clinical Investigations
6 January 2022 by CITI Program

In December of 2021, the FDA released a Draft Guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” Clinical trials may…

FDA Releases Draft Guidance on Real-World Evidence (RWE) in Clinical Trials
4 January 2022 by CITI Program

On December 9, 2021, the U.S. Food and Drug Administration (FDA) released draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence…

What CITI Program is Reading – December 14, 2021
14 December 2021 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 December 2021 Media Playlist – Part 2
11 December 2021 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…

Gene Therapy Consortium Launches
8 December 2021 by CITI Program

In October 2021, the National Institutes of Health (NIH) announced the launch of the Bespoke Gene Therapy Consortium (BGTC), part of their Accelerating Medicines Partnership…

What CITI Program is Reading – December 7, 2021
7 December 2021 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,…

(EU) No 536/2014 Regulation Comes into Application in January 2022
7 December 2021 by CITI Program

On January 31, 2022, the new European Medicines Agency (EMA) Clinical Trials Regulation (Regulation (EU) No 536 / 2014) comes into effect according to the…

Update to OHRP’s Incident Reporting System
3 December 2021 by CITI Program

As of January 2, 2022, institutions will be required to submit OHRP incident reports, electronically, via the new online form (unless they are unable to…

Free Download – FDA Funded “Playbook for Threat Modeling Medical Devices”
3 December 2021 by CITI Program

MITRE and the Medical Device Innovation Consortium (MDIC), with funding by the U.S. Food and Drug Administration (FDA), has released “Playbook for Threat Modeling Medical…

What CITI Program is Reading – December 1, 2021
1 December 2021 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 December 2021 Media Playlist – Part 1
1 December 2021 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…