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Compliance In Focus


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Posted by Emily Haglund on Tue, Oct 25, 2016

Increased Transparency Requirements with clinicaltrials.gov

The US Department of Health and Human Services (DHHS) recently released a final rule regarding the specific requirements for the registering and results submission of clinical trials within the clinicaltrials.gov database. As previously, the final rule applies to “responsible parties” for “applicable clinical trials.” Responsible parties are frequently the sponsor of a clinical trial or principal investigator. Applicable clinical trials must meet certain criteria.

Topics: National Institutes of Health, FDA ClinicalTrials.gov, The Department of Health and Human Services

Posted by Rachel Silver on Mon, Jul 09, 2018

National Institutes of Health (NIH) Founded - 1887

Originally named the Hygienic Laboratory, the National Institutes of Health (NIH) was founded by Joseph J. Kinyoun of the Marine Hospital Service (MHS) in 1887. From humble beginnings, this one-room laboratory relocated to Washington, D.C. in 1891, and a new building was constructed in 1901. The NIH’s founding legislation was unceremoniously part of an appropriations act approving the $35,000 building for the laboratory to investigate “infectious and contagious diseases and matters pertaining to the public health.” They Hygienic Laboratory was restructured and granted funding in 1902, and remained at the first official building until 1941.

Topics: NIH, National Institutes of Health, History of Clinical Research Timeline

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.