“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,…
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…
“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,…
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…
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…
“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,…
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…
“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,…
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…
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…
“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,…
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…
