by Wendy Tate, PSP, CIP
Just this year, a mere four months since the start of the year, the United States Food and Drug Administration (FDA) has issued seven warning letters to clinical investigators. Four of these letters cite investigators for failure to personally supervise their human subjects research. This is a violation of FDA regulation 21 CFR 312.60, which specifically states that:
“An investigator [...] Read more
Posted by guest blogger Eunice Newbert, Manager, Education and Quality Improvement Program at Children's Hospital Boston
After conducting study reviews of ongoing clinical trials for almost six years as part of the Education and Quality Improvement Program (EQuIP) at Children's Hospital Boston, my favorite part is, of all things, witnessing the evolution of investigators. However, it is not in terms of improvement quantitatively gauged through metrics, but rather in their notable change of perspective and understanding, indicative in their increased willingness to learn and improve.
As more research institutions implement quality improvement (QI) efforts to improve the protection of [...] Read more