Recently, the European Medicines Agency (EMA) sent out a survey to its stakeholders asking for their opinion regarding a new clinical trials database design. The rationale for EMA asking its stakeholders for their opinions is due to new regulations that were created...
The National Institutes of Health’s (NIH) National Institute for Allergy and Infectious Diseases (NIAID) launched a new website, ClinRegs, designed to provide country-specific information on clinical trial regulations. The website contains a number of resources to...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
