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Title: Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory]

Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected from subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports.
Authors:
Publication Date:
OSTI Identifier:
811796
DOE Contract Number:
FG02-99ER62780
Resource Type:
Technical Report
Resource Relation:
Other Information: PBD: 29 May 2001
Research Org:
HYGEIA Research Associates, Inc., Commack, NY (US)
Sponsoring Org:
Office of Biological and Environmental Research, USDOE Office of Science (SC) (US)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BNL; BORON; CLINICAL TRIALS; COMPLIANCE; ISRAEL; MEDICAL ESTABLISHMENTS; NEUTRON CAPTURE THERAPY; RECOMMENDATIONS; REGULATIONS NEUTRON CAPTURE THERAPY; BNL; NEW YORK; INSPECTION; EVALUATION; BORON; REGULATIONS; MAN