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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” 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.

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” 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.

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 […]

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” 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 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 […]

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 […]

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” 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.

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” 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.

“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 […]

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” 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” 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” 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” 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” 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 […]

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” 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 […]

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” 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 […]

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, […]

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” 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 […]

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 […]

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 […]

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 […]

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 […]

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 […]