Carlos Lastra MD – FDA 483, Jan 13, 2020
Carlos Lastra MD, a clinical investigator in New Brunswick, NJ, was cited for significant deficiencies in informed consent procedures and adherence to investigational protocols. The firm failed to provide informed consent forms in a language understandable to subjects' representatives and did not ensure subjects completed required follow-up visits or telephone contacts according to study plans. These issues indicate serious concerns regarding patient safety and data integrity in clinical trials.
ID · 2bef8bd0-7247-495c-b00b-eb51eea0488d
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