Blog

FDA Establishes New Office of Digital Transformation

16 September 2021 by CITI Program

As part of the The U.S. Food and Drug Administration’s technology and data modernization effort, the Office of Digital Transformation (ODT) has been established to include the agency’s information technology (IT), data management, and cybersecurity functions. Along with a 2022 budget request that includes funding to support the agency’s data and IT modernization efforts for […]

What CITI Program is Reading – September 21, 2021

16 September 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Kick Off Peer Review Week With a Free CITI Program Webinar

16 September 2021 by CITI Program

Peer Review Week (PRW) is a yearly event celebrating the essential role of peer review in maintaining scientific quality. From September 20-24th, many of the virtual events and activities will highlight this year’s theme, “Identity in Peer Review.” Visit the PRW website for a full list of activities including online events, blogs, videos, and information […]

Who’s #1? 2022 Best National University Rankings

15 September 2021 by CITI Program

U.S. News and World Report has released its annual best national university rankings with Princeton University leading the way. This latest report evaluates 1,466 U.S. bachelor’s degree-granting institutions on several factors of academic quality. The ranking methodology is a combination of years of research and refinements to the approach based on data and feedback from […]

What CITI Program is Reading – September 14, 2021

14 September 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Medical Boards Issue Joint Statement on Physician Responsibility

10 September 2021 by Raymond Longaray, CITI Program

In response to concerns raised by Diplomates and the public regarding COVID-19 disinformation, the American Board of Family Medicine (ABFM), the American Board of Internal Medicine (ABIM), and the American Board of Pediatrics (ABP) have issued a joint statement to physicians, reminding them of their responsibility to individual and public health by providing factual and […]

What CITI Program is Reading – September 8, 2021

8 September 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

What CITI Program is Reading – August 31, 2021

31 August 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Training Clinical Investigators with CITI Program Courses

27 August 2021 by CITI Program

Investigators are ultimately responsible for the conduct of a clinical trial per U.S. Food and Drug Administration (FDA) regulations at 21 CFR 56 and per ICH E6(R2) Good Clinical Practice (GCP) guideline. CITI Program offers many courses to help investigators gain knowledge and deepen their skillsets. Start with our foundational training and supplement with a […]

What CITI Program is Reading – August 24, 2021

24 August 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

WHO Seeks Comments for New Draft GMP Guidelines

20 August 2021 by CITI Program

The World Health Organization (WHO) has released a draft working document for comments on good manufacturing practices (GMP) for investigational products. They also issued a new draft guideline for comments on pharmaceutical products that covers GMP principles of pharmaceutical products for research and development facilities. These draft revisions were inspired by the COVID-19 pandemic. Comments […]

Enforcement for FDA’s ClinicalTrials.gov Requirements

19 August 2021 by CITI Program

To comply with the ClinicalTrials.gov requirements, responsible parties should submit registration and summary results information for certain applicable clinical trials, as per regulations at 42 CFR 11. Until this year, the U.S. Food and Drug Administration (FDA) had not enforced this regulation. Timeline The following is a brief timeline of FDA enforcement actions, statements, and […]

What CITI Program is Reading – August 18, 2021

18 August 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

Joint Letter on Scientific Integrity to the White House OSTP

10 August 2021 by CITI Program

In response to a request for information to improve federal scientific integrity policies, the American Association for the Advancement of Science (AAAS), Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR) have issued a joint letter to the White House […]

What CITI Program is Reading – August 10, 2021

10 August 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.

NIH Studies Its Processes to Ensure Diversity in Clinical Trials

9 August 2021 by CITI Program

The NIH supports over $31 billion of biomedical and public health research and has long been concerned with the underrepresentation of minority groups in clinical trials and its effect of on these populations. The NIH’s Office of Evaluation and Inspections has recently announced a study to review how the NIH monitors and responds to clinical […]

Recent Guidance on Semiannual Inspections of Animal Facilities

9 August 2021 by CITI Program

In response to a recent NIH Request for Information (RFI), the public suggested having inspections occur annually instead of semiannually as way to reduce the administrative burden on investigators. However, it was determined that the potential risks to animal welfare outweighed the burden on the IACUC and the principal investigator. On August 2, 2021, the […]

What CITI Program is Reading – August 3, 2021

3 August 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, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program.