Bioresearch Monitoring Alert articles from December 2003

Bioresearch Monitoring Alert archives from December 2003

Expecting unexpected AEs can reduce IRB reporting burden; FDA not inclined to expand DMCs to help out.(Adverse events)(Institutional Review Boards)(United States. Food and Drug Administration)(data monitoring committees)
December 1, 2003... Institutional Review Boards (IRBs) that carefully consider likely adverse events and protocol deviations in a prospective protocol will be able to better manage the increasing burden of reporting adverse events, but it seems FDA and other...

OHRP's Schwetz sees 'failed studies' as means to minimize harm to subjects.(Human subject protection)(Office for Human Research Protections)
December 1, 2003... A proposal by Office for Human Research Protections (OHRP) Acting Director Bernard Schwetz, Ph.D., to create a federal government database of "failed clinical trials" in order to avoid exposing subjects to experimental drugs that were canceled...

OHRP, FDA sharing information on IRBs, trying to avoid duplicate audits.(Inspections/IRBs)(United States. Department of Health and Human Services. Office of Human Research Protection)(United States. Food and Drug Administration)(Institutional Review Boards)
December 1, 2003... FDA and OHRP are increasingly sharing information and trying to avoid doing duplicate audits of IRBs, officials told the annual PRIM&R conference in Washington Dec. 6. While OHRP has the lead on IRB oversight over federally funded studies,...

Final FDA guidance seen in '04; official argues against mandating DMCs.(Data monitoring committees)(data and safety monitoring committees)(United States. Food and Drug Administration)
December 1, 2003... An FDA official Dec. 7 predicted the agency would issue a final guidance next year on data and safety monitoring committees (DMCs) in clinical trials, but doubted the agency will expand the use of DMCs in order to assist IRBs in handling...

Sponsor has devices implanted before IRB approval; financial disclosure cited, too.(Sponsor/Monitor)(Plus Orthopedics)
December 1, 2003... Plus Orthopedics, San Diego, CA, Los Angeles District Implanting investigational devices prior to IRB approval and before signing agreements with clinical investigators yielded sponsor/monitor Plus Orthopedics a 483 following an April 2003...

Firm escapes 483 despite numerous validation, documentation deficiencies.(GLP)(Redfield Laboratories)
December 1, 2003... Redfield Laboratories, Division of Charles Rivers Laboratories, Redfield, AR, Dallas District Although Redfield Laboratories' non-clinical lab lacked SOPs for installing computerized operating systems and software, and FDA's Dallas...

CI enrolls subjects not meeting inclusion criteria.(Clinical investigators)
December 1, 2003... Steven Yakubov, M.D., Midwest Cardiology Research, Columbus, OH, Cincinnati District FDA investigator Hugh McClure from the Cincinnati District handed clinical investigator Steven Yakubov, M. The 483 stated that Yakubov also enrolled...

Investigator sails through inspection.(Clinical investigators)(Clinical Therapeutics Corp.)
December 1, 2003... Rafael Montorro, M.D., Clinical Therapeutics Corp., Coral Gables, FL, Florida District Clinical Investigator Rafael Montorro, M.D., received a clean bill of health from FDA following a PDUFA pre-approval study, orientated data validation...

Warning letters.
December 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Nov. 24 and Dec. 1 and 8, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

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

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