Blog

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.

New OHRP Incident Reporting Form and Instructions

29 July 2021 by 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 – 27 July 2021

27 July 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 – 20 July 2021

20 July 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.

Integrating Sex as a Biological Variable (SABV) in Biomedical Research

16 July 2021 by 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. […]