Bioresearch Monitoring Alert articles from August 2003

Bioresearch Monitoring Alert archives from August 2003

Hopkins seeks HIPAA clarification to contact subjects about future trials.(HIPAA)
August 1, 2003... Johns Hopkins University School of Medicine in Baltimore has asked the U.S. Office of Civil Rights to clarify whether the privacy rules under the Health Insurance Portability and Accountability Act (HIPAA) would allow it to ask patients, before...

Final FDA safety regulations may flood IRBs and, sponsors, do little for 'risk management'.(Safety reporting)
August 1, 2003... PHILADELPHIA -- FDA's proposed regulation governing safety reporting of drugs and biologics may wind up overburdening sponsors and IRBs with extra suspected adverse drug reaction reports (SADRs), but not do much for "risk management," which the...

CDRH to begin surveillance audits of investigators in fall.(BiMo inspections)
August 1, 2003... PITTSBURGH -- FDA's Center for Devices this fall will formally begin surveillance inspections of select clinical investigators working under investigational device exemptions (IDE). Jean Toth-Allen, biophysical/consumer safety officer in...

Amgen eyes monitoring program to ensure CROs, others comply with Part 11.(CROs/electronic records)
August 1, 2003... CHICAGO -- Concerned that compliance by contractors with FDA's electronic signature/records rule is not as vigilant as it could be, thus giving drug and device firms more liability exposure, Amgen is in the process of launching a monitoring...

Firm narrowly escapes 483; FDA flags numerous issues.(GLP)
August 1, 2003... Bristol-Myers Squibb, New Brunswick, NJ, New Jersey District FDA investigator Byung-ja Marciante of the New Jersey District did not issue a 483 to Bristol Myers Squib's non-clinical testing facility in New Brunswick, NJ, although several...

CI cited for missing informed consent form, protocol deviations, test article deficiencies.(Clinical investigators/IRBs)
August 1, 2003... Ronald Crystal, M.D., Institute of Genetic Medicine, New York, NY, New York District Four out of six patients enrolled in this gene therapy trial did not meet the protocol's entry criteria, discovered investigator Thomas Hansen from FDA's...

Experienced PI gets 483 for informed consent issues, protocol deviations.(Clinical investigators/IRBs)
August 1, 2003... Larry Gilderman, M.D., University Clinical Research, Pembroke Pines, FL, Florida District FDA investigators Brunilda Torres and Jennifer Menendez from the Florida District uncovered informed consent deficiencies, an unreported adverse...

FDA finds no evidence of foul play despite complaint lodged.(Clinical investigators/IRBs)
August 1, 2003... David Alberts, M.D., University of Arizona Cancer Center, Tucson, AZ, Los Angeles District A complaint alleging that serious adverse events involving hospitalizations had been improperly reported or had not been reported to the IRB, FDA or...

Patient threatened with non-payment for withdrawing from study.(Clinical investigators/IRBs)
August 1, 2003... Colin Bailey, M.D., LaPlace, LA, New Orleans District Numerous protocol deviations and documentation errors were cited in a 483 by FDA's New Orleans District investigators Barbara Wright and Donna Gallien following an inspection of clinical...

BiMo FOIA log.(Clinical investigators/IRBs)
August 1, 2003... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, sponsor/monitors, IRBs and clinical investigators, which were filed with FDA under the Freedom of Information Act (FOIA). This list does not...

Warning letters.(Brief Article)
August 1, 2003... The following is a recent FDA warning letter to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs issued the weeks of July 8, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W,...

Untitled letters.
August 1, 2003... The following untitled letters were issued by the Division of Bioresearch Monitoring of the Center for Devices, Office of Compliance (CDRH-OC) in 2002. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus...

IRB Determination Letters.
August 1, 2003... The following are Compliance Determination Letters for IRBs issued in March and April by the Department of Health and Human Services Office of Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to...