All Clinical Research Sites (CRSs), where required by country regulation or law, must have secured clinical trials insurance for every new and ongoing clinical trial sponsored by DAIDS to ensure compliance with the European Medicines Agency Committee for Proprietary Medicinal Products, Art 5.8 CPMP/ICH/135/95 and the Integrated Addendum to ICH (E6) (R1): Guideline for Good Clinical Practice E6 (R2) regarding Investigator/Institution insurance against trial related claims.
Currently, the U.S. does not have a law or regulation requiring the purchase of Clinical Trials Insurance.
List of Countries Requiring Clinical Trials Insurance for DAIDS funded CRSs*
|CRS Continent||CRS Country|
|N. America||Canada (depends on province)|
*Information is current as of 08/19/2021