Bioresearch Monitoring Alert articles from October 2002

Bioresearch Monitoring Alert archives from October 2002

IOM calls for federal board to oversee human subject safeguards; Kennedy introduces research protection bill. (Human subject protection).
October 1, 2002... In a report that could have major implications for human subject protection in the U.S., an Institute of Medicine (IOM) panel is recommending that all organizations doing clinical trials come under federal oversight and create separate...

CDRH BiMo audits up 38%, IRB audits double in FY '02. (Inspections).
October 1, 2002... FDA's Center for Devices conducted about 38% more bioresearch monitoring (BiMo) inspections in fiscal 2002 versus 2001, but audits of IRBs nearly doubled in the same time period, a CDRH official told the annual Regulatory Affairs...

OIG to examine use of DMCs in NIH trials; management of DMCs seen a key issue. (Data monitoring committees).
October 1, 2002... PHILADELPHIA -- While attendees of a Barnett/Parexel conference on data monitoring committees held here Oct. 2-3 agreed that DMCs were crucial bodies for keeping clinical trials safe and effective, the question remained--how best to create...

OHRP reviews 100 cases a year, but fewer than eight go anywhere. (IRBs).
October 1, 2002... Despite the broad reach of the Office of Human Research Protections (OHRP) and its sweeping powers to shut down IRBs and deprive institutions, such as universities, from enrolling patients in clinical studies, OHRP reviews only about 100...

OHRP ready to begin not-for-cause `QI' reviews; OIG to examine pediatric subject protection. (IRBs).
October 1, 2002... The Office of Human Research Protections (OHRP) Sept. 12 issued an open letter to the human research community detailing the success of its Quality Improvement (QI) program and OHRP's plan to expand their not-for-cause research evaluations...

FDA clinical data tracking system needs improvement, staffer says. (Clinical trials).
October 1, 2002... BETHESDA, MD -- "A well-designed agency-wide information management system is needed" to better track and use data. That was the conclusion reached through a recent internal assessment by FDA's Office of Women's Health, the Office's Senior...

Koski to leave OHRP at end of November.
October 1, 2002... Greg Koski, M.D., will leave his position Nov. 30 as OHRP's first director to return to Harvard University, from where he originally came in September 2000 to beef up HHS oversight of human subject protections. Koski said he wants to...

Poor documentation, unsigned consent form triggers 6-item 483. (Clinical Investigators).
October 1, 2002... Gildon Beall, M.D., Harbor/UCLA Medical Center, Torrance, CA, Los Angeles District Gildon Beall, M.D., was attending a conference in South Africa when FDA agent Yumi Hiramine of the Los Angeles District came to inspect the Harbor/UCLA...

Missing and incomplete records result in 483.
October 1, 2002... Leann Olansky, M.D., Metabolic Research Center, OUHRC, College of Medicine, Oklahoma City, OK, CDER A comprehensive data audit inspection of protocol revealed a shaky paper trail for clinical investigator Leann Olansky, M.D., at the...

Sponsor training of two Texas investigators help them breeze through FDA BiMo audits.
October 1, 2002... Charles Van Buren, M.D., University of Texas School of Medicine, Houston, TX, Jeffrey Whitsett, M.D., Houston, TX, Dallas District Good training by sponsors of two drug clinical trials helped Charles Van Buren, M.D., and Jeffrey Whitsett,...

FDA audit results in widespread organizational changes, including DMC.
October 1, 2002... Caio Max Rocha-Lima, M.D., Medical University of South Carolina Hollings Cancer Center, Charleston, SC, Atlanta District An anonymous complaint prompted FDA to initiate an inspection of clinical investigator Caio Max Rocha-Lima, M.D., of...

Investigator fares well overall, but draws 483 for destroyed records, protocol deviations.
October 1, 2002... Gary DeVane, M.D., Center for Infertility and Reproductive Medicine, Orlando, FL, Florida District A May 2000 user fee data validation inspection focused on clinical investigator Gary DeVane, M.D., at the Center for Infertility and...

Warning letters.
October 1, 2002... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs, which were issued in September 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 11893W)....

BiMo FOIA Log.
October 1, 2002... 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...

IRB Determination Letters.
October 1, 2002... The following are Compliance Determination Letters for IRBs issued in September 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...