Bioresearch Monitoring Alert articles from October 2003

Bioresearch Monitoring Alert archives from October 2003

FDA targeting high-enrolling sites; 12-15% of 483 citations concern adverse event reports.(Inspections)
October 1, 2003... FDA is looking more closely at high-enrolling sites and sites conducting multiple studies as initial targets of a BiMo inspection, and auditors are closely examining whether adverse event reports were filed. Addressing the Center for...

FDA moving away from INDs for biodefense, orphan status suggested.(Bioterrorism)(investigational new drug )
October 1, 2003... FDA is trying to change its focus in getting products off investigational new drug (IND) status for biodefense approvals, and one policy analyst suggested orphan status for such medicines. Addressing a Food & Drug Law Institute conference...

FDA to create new councils to oversee cross-cutting functions.(FDA management)
October 1, 2003... FDA Commissioner Mark McClellan, M.D., has assigned Center for Drugs Director Janet Woodcock, M.D., to a six-month assignment in his office to coordinate a new "Strategic Action Plan" for the agency, which includes the creation of two new...

Forms should be user friendly, tie in with source documents.(CRFs/source documents)
October 1, 2003... RANCHO MIRAGE, CA -- FDA auditors cite deficiencies in record keeping as the most common shortfall found during BiMo inspections, and much could be done to reduce 483 observations and warning letters if clinical sites had better-written case...

Research education should include HIPAA privacy rules, IRB regulations.(Clinical investigators)(Health Insurance Portability and Accountability Act of 1996)
October 1, 2003... RANCHO MIRAGE, CA -- Sponsors, CROs or institutions seeking to implement a clinical research education program for investigators and coordinators should consider at least a "luncheon lecture" on the new HIPAA privacy rules as well as...

Duke recommends annotations of common repeat events.(Adverse Event Reporting)(Duke Clinical Research Institute)
October 1, 2003... RANCHO MIRAGE, CA -- Research sites may want to annotate common and repeated adverse events on the same adverse event reporting form, a Duke Clinical Research Institute official reported here Sept. 20. Gerard Esposito, clinical trials...

GLP audit reveals lack of written procedures.(GLP)
October 1, 2003... Roswell Park Cancer Institute, Inc., Buffalo, NY, New York District An unannounced surveillance GLP inspection conducted by the New York District's Russ Davis and prompted by the Center for Drugs, yielded a six-item 483 for Roswell Park...

CI falsifies data, fabricates patients, forges informed consent forms.(Clinical investigators)
October 1, 2003... Allyn Norman, D.O., North Forest Medical Associates, Getzville, NY, New York District Serious deficiencies, including falsification of data and fabrication of subjects were uncovered during a clinical investigator audit of Allyn Norman,...

483 cites CI for source documentation errors, protocol deviations.(Clinical investigators)
October 1, 2003... Valerie Scott, M.D., James Island Medical Care, Charleston, SC, Atlanta District Clinical investigator Valerie Scott, M.D., hit a few snags in her first FDA inspection at James Island Medical Care, Charleston, SC, and received a four-item...

CI fails to report serious adverse events to IRB.(Clinical investigators)
October 1, 2003... Julia Breyer Lewis, M.D., Vanderbilt University Medical Center, Nashville, TN, New Orleans District Failure to report serious adverse events to the IRB was the most serious deficiency cited in a three-item 483 received By Julia Breyer...

Warning letters.(United States Food and Drug Administration)
October 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Sept. 8, 15, 22 and 29, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

BiMo FOIA log.(Freedom of Information Act)
October 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...