IRAD-FEOR documentation
Single opinion in multicentre non-drug observational studies
Document related to the reassessment of multicentre non-drug observational studies that already have a positive opinion from an IEC.
Problem description
In multicentre non-drug observational studies, it is common for many participating centres to require reassessment of studies that already have a positive opinion from an IEC.
This significantly increases the cost and complexity of studies […]
