You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Recently, the United States Department of Health and Human Services and the National Institute of Health (NIH) issued two proposed rulings that may have a profound impact on how results of clinical trials are made more transparent to the public. However, before we discuss these proposals, we should discuss briefly how the public has access to clinical trials.
Topics: NIH, ClinicalTrials.gov, National Library of Medicine, FDA, Clinical Research
When a monitor has a tiny epiphany while working through a difficult compliance issue with a site, or an ‘Ah-ha!’ moment, we call that a ‘Regulation Revelation.’ After reviewing an informed consent that lacked the required statement regarding registration on clinicaltrials.gov (21 CFR 50.25(c)), I discussed it with the sponsor and had an ‘Ah-Ha!’ moment I’d love to share.
Topics: Informed Consent, ClinicalTrials.gov, Regulation Revelation