Track which instruments are qualified, accepted as endpoints, or referenced in guidance by global health authorities - with source documents and contexts of use.
Scientific evaluation, supervision and safety monitoring of medicines in the EU. Issues qualification opinions on novel methodologies including clinical outcome assessments.
Regulates drugs, devices, and biologics in the United States. Operates the Clinical Outcome Assessment (COA) Qualification Program and Drug Development Tool (DDT) program.
Canadian federal authority for therapeutic products and clinical trial oversight.
UK regulator of medicines, medical devices and blood components for transfusion.
Japanese regulatory authority for pharmaceuticals and medical devices. Reviews clinical outcome assessment use in registration trials.
Australian regulator for therapeutic goods including medicines and medical devices.