Bioresearch Monitoring Alert articles from July 2004

Bioresearch Monitoring Alert archives from July 2004

BiMo audits to focus more on risk, adopt QS approach by end of '04.(Inspections)(quality system)
July 1, 2004... SAN DIEGO -- FDA BiMo inspections may soon adopt some of the precepts being used in drug and device "quality system" inspections and focus auditors more on risk. David Lepay, M.D., senior adviser for clinical science and director of the...

Federal prosecutors looking closely at off-label use trials.(Compliance)
July 1, 2004... PHILADELPHIA -- While clinical trials examining the off-label use of drugs are allowed by FDA, they are an area of increasing concern for the Department of Justice (DOJ), according to Virginia Gibson, Associate U.S. Attorney for the...

EMA not seen becoming a Super FDA for Europe.(European Medicines Agency)(Food and Drug Administration)
July 1, 2004... WASHINGTON -- The goal of the European Medicines Agency (EMA) becoming a direct counterpart, at least for the governance of clinical trials, appears to be hampered by EU member states "jealously guarding" the authority they have in the...

Some foreign sites quizzing prospective subjects to see if they understand consent forms.(Informed consent)(Brief Article)
July 1, 2004... WASHINGTON -- Some non-U.S. clinical trial sites are starting to quiz prospective subjects to see how much they comprehended from the informed consent process, while others are using videos to provide clarity. Shelly Schiff, president of...

HIPAA seen becoming next major hurdle following Part 11.(Subject recruitment)(authorization of Health Insurance Portability and Accountability Act)(personal health information)
July 1, 2004... SAN DIEGO -- Obstacles to patient and investigator recruitment can be overcome by following effective recruitment principles and good practices, clinical trial managers told a recent ACRP meeting, but the privacy regulations of the Health...

Accreditation of organizations and researchers, plus data-mining seen as future of clinical research.(Accreditation)
July 1, 2004... PHILADELPHIA -- Accreditation and data-mining are changing the face of clinical trials, according to John Kelly, a health care consultant and former senior VP of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers...

Consent and documentation failures net CI a two-part 483.(Clinical investigators)
July 1, 2004... Clinton Corder, M.D., Oklahoma City, OK, Dallas District Clinton Corder, M.D., of Oklahoma City, OK, received a two-part 483 for failure to have subjects sign the current IRB-approved consent form and failure to document the actual amount...

Clinkingbeard earns clean report from FDA.(Clinical investigators)(Cynthia Clinkingbeard)
July 1, 2004... Cynthia Clinkingbeard, M.D., Boise, ID, Seattle District No 483 was issued during a recent inspection by Seattle District's Carl Anderson for Cynthia Clinkingbeard, M.D., of Boise, ID. The report noted this was the initial inspection...

Inspection results in no 483 for research lab, but minor management issues noted.(CROs/contract testing labs)
July 1, 2004... Southern Testing & Research Lab, Wilson, NC, Atlanta District A second inspection for Southern Testing & Research Lab, Wilson, NC, found no violations and no 483 was issued. However, investigator Jawaid Hamid of the Atlanta District...

Warning letters.
July 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of June 14, 21, 28, and July 5. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

IRB determination letters.(Institutional Review Boards)(Brief Article)
July 1, 2004... The following are Compliance Determination Letters for IRBs issued in May by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these...