Blog

National Women’s Health Week 2021

13 May 2021 by CITI Program

Led by the U.S. Department of Health and Human Services’ Office on Women’s Health (OWH), National Women’s Health Week 2021 spans from 9–15 May and serves as a reminder for women of all ages to take care of their health. Visit the OWH website linked below for resources including this year’s fact sheet and information […]

What CITI Program is Reading – 11 May 2021

11 May 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.

Mental Health Awareness Month 2021

6 May 2021 by CITI Program

Started in 1949, by Mental Health America (MHA), Mental Health Awareness Month is a time to raise awareness and educate the public about mental illness, its realities, and the importance of mental health and wellness. This year’s theme is Tools 2 Thrive. A toolkit with sample materials for communications and social media as well as […]

What CITI Program is Reading – 4 May 2021

30 April 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.

FDA’s First Notice of Noncompliance with ClinicalTrials.gov requirements

30 April 2021 by CITI Program

On 28 April 2021, the FDA issued its first Notice of Noncompliance to a company failing to submit required summary results information to ClinicalTrials.gov. They determined that the responsible party failed to comply with its legal reporting obligations, even after receiving a Pre-Notice of Noncompliance. They will now have 30 days to submit the required […]

ICH Releases Draft Principles for GCP

21 April 2021 by CITI Program

On 19 April 2021, the ICH E6 working group shared a work-in-progress version of updated principles for E6. This is an early look at the first work product for the E6(R3) guideline. What is ICH E6(R3)? The International Council for Harmonisation (ICH) E6(R2) guideline for good clinical practice (GCP) is the current global standard for […]

What CITI Program is Reading – 4/27/21

27 April 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.

Virtual Workshop Series on Postsecondary Response to COVID-19

26 April 2021 by CITI Program

The Board on Higher Education and Workforce (BHEW) brought together a committee to discuss how higher education institutions are supporting the COVID-19 response efforts. The discussion is available now as a seven-part series which includes the following webinars: How can researchers help the national response efforts? How can and are laboratories shifting research agendas? How […]

NIH and OSTP New Foreign Support Requirements and Recommendations

21 April 2021 by CITI Program

The impact of undue foreign influence in research, particularly at universities, remains a concern for U.S. federal officials and university administrators. Earlier this year the White House Office of Science and Technology Policy (OSTP) published guidance focusing on undue influence from foreign governments and government-sponsored talent recruitment programs. This guidance includes five broad goals, including […]

Hackers Publish Broward School District Accounting and Financial Records

21 April 2021 by CITI Program

The Broward County public school district has fallen victim to a recent ransomware attack. A refusal to pay the $40,000,000 ransom has resulted in the leak of almost 26,000 stolen files including accounting and financial records such as invoices, purchase orders, and travel and reimbursement forms. The Broward Schools Chief Information Officer has stated the […]

What CITI Program is Reading – 4/20/21

20 April 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.

Updates to the GCP Mutual Recognition Website

14 April 2021 by CITI Program

TransCelerate BioPharma announced that their GCP Course List webpage has a new link. This webpage lists training providers and mutually recognized courses, as well as provides example completion certificates. The new page aims to improve the user experience while automating existing processes. Some changes include the following: An updated user interface New search function for […]

What CITI Program is Reading – 4/13/21

13 April 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.

National Public Health Week 2021 – Building Bridges to Better Health

9 April 2021 by CITI Program

“Building Bridges to Better Health” is this year’s theme for National Public Health Week (NPHW). Visit the official website for a full list of events including the APHA Policy Action Institute’s “Building Bridges: Creating Health” on April 8-9 as well as tips for staying involved. You can also access resources including the following: COVID-19: What […]

GCP Renovation and Revision: Preparing for ICH E6(R3)

8 April 2021 by CITI Program

The International Council for Harmonisation (ICH) E6(R2) guideline for good clinical practice (GCP) is the current global standard for clinical trials. However, the ICH currently has a working group tasked with revising it (referred to as “R3” as it is the third revision). According to the November 2019 Final Concept Paper for ICH E6(R3), the […]

What CITI Program is Reading – 4/8/21

8 April 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 – 3/30/21

30 March 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 – 3/23/21

23 March 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. Justice, diversity, and research ethics review Examine the role of the Institutional Review Boards […]

What CITI Program is Reading – 3/17/21

17 March 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’s in the huge pandemic relief bill for science? Stimulus payments for millions of […]

What CITI Program is Reading – 3/9/21

9 March 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. China spending on research and development to rise 7% per year in push for […]

The CDC Updates its Tips to Prepare for a Zombie Apocalypse

8 March 2021 by CITI Program

A zombie apocalypse may seem far-fetched. However, the CDC has provided tips to prepare for this exact situation. What started off as a satirical campaign, actually serves as a practical guide for many common emergencies like hurricanes and earthquakes. Disaster preparedness is crucial and experts agree this campaign has been very effective in conveying that […]

What CITI Program is Reading – 3/2/21

2 March 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. The Ethics of Repurposing Previously Collected Research Biospecimens in an Infectious Disease Pandemic The […]

Observational Research and COVID-19: Understanding a New Virus

2 March 2021 by CITI Program

When the COVID-19 pandemic began in March 2020, the world did not have available treatment or vaccines for the new virus and respiratory disease. To understand what the disease was, how to treat it, how to prevent its spread, and how public health measures like lockdowns were impacting us, researchers turned to observational research. Observational […]

What CITI Program is Reading – 2/23/21

23 February 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. The next act for messenger RNA could be bigger than covid vaccines Messenger RNA […]

Download Achieving Diversity, Inclusion, and Equity in Clinical Research

19 February 2021 by CITI Program

The Multi-Regional Clinical Trials (MCRT) Center is a research and policy center associated with Brigham and Women’s Hospital and Harvard University. As part of their vision to improve the integrity, safety, and rigor of global clinical trials, The Multi-Regional Clinical Trials (MCRT) Center has released version 1.1 of their comprehensive guidance and toolkit “Achieving Diversity, […]

Alleged False Claims Acts Violations Prove Costly for Healthcare Company and Lab

18 February 2021 by CITI Program

Cordant Health Solutions, which provides healthcare testing and monitoring nationwide, have agreed to pay $845,108 to federal and state governments as part of a civil settlement agreement. The Office of the Inspector General for the Department of Health and Human Services, and the Connecticut Office of the Attorney General alleged that Cordant violated the False […]

What CITI Program is Reading – 2/16/21

16 February 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. Sanofi to help produce 100 million Pfizer/BioNTech vaccine doses The French biopharmaceutical company aims […]

Wearable Device Data Identifies COVID-19 Infection and Predicts Diagnosis

11 February 2021 by CITI Program

A recent observational study by the Icahn School of Medicine at Mount Sinai has shown that physiological data from a wearable device can predict COVID-19 infection and symptoms. Metrics collected from Health care workers wearing Apple Watches in the Mount Sinai Health System showed significant changes in heart rate variability (HRV) among subjects with COVID-19 […]

Practical, Efficient, and Cost-Effective Study Designs in Observational Research

4 February 2021 by Ilene Wilets, PhD – Icahn School of Medicine at Mount Sinai

Introduction Clinical research has taught us vital public health lessons over the years. We now know that smoking is a significant risk factor for emphysema, being overweight can lead to pre-diabetes, and drinking a glass of red wine with dinner offers benefits beyond winding down after a tough day. While randomized clinical trials (RCTs) are […]

What CITI Program is Reading – 2/9/21

9 February 2021 by CITI Program

Welcome to the first edition of our weekly blog series, “What CITI Program is Reading,” 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 publishes public health research agenda for managing infodemics […]

FDA’s New AI/ML Device Regulation Action Plan

20 January 2021 by CITI Program

On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as provide a reasonable assurance of safety and effectiveness of artificial intelligence and machine learning-based software as a medical device (SaMD). This multi-faceted plan includes: Tailored Regulatory Framework for AI/ML-based SaMD […]

CDC and Vaccine Safety

4 January 2021 by CITI Program

On 22 December 2020 the U.S. Centers for Disease Control and Prevention (CDC) updated their Ensuring the Safety of COVID-19 Vaccines in the United States webpage. The CDC highlights a number of expanded and existing safety monitoring systems associated with monitoring vaccine safety. You will also find links to the their “V-safe After Vaccination Health […]