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