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“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.

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” 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.

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” 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 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 […]

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” 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.

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” 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 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 […]

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” 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 regulations at 45 CFR 46 for nonexempt research conducted or supported by the U.S. Department of Health and Human Services (HHS) require prompt reporting of incidents to OHRP. These incidents include the following:   Unanticipated problems involving risk to subject or others Serious or continuing noncompliance Suspension or termination of IRB approval   On […]

“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.

The National Institutes of Health (NIH) Office of Research on Women’s Health (ORWH) now offers the course Sex as a Biological Variable: A Primer. Intended for researchers, NIH grant applicants, and peer reviewers, the course examines how SABV can be accounted for and properly integrated within research design, analyses, and other aspects of biomedical sciences. […]