To better clarify the IRBs position in investigating clinical investigators and sites for clinical trials, the Food and Drug Administration (FDA) has released draft guidance for reviewing those qualifications.
A new study has found that while nine out of 10 clinical trials worldwide meet enrollment goals, reaching those goals could mean doubling original timelines.
It is a natural electronic data evolution: First, IRBs began using electronic data systems; then these morphed into full electronic submission, and now IRBs are collecting valuable electronic, real-time data that can be mined very quickly for process and quality improvement purposes. Metrics are key to this transition.
