Bioresearch Monitoring Alert articles from November 2002

Bioresearch Monitoring Alert archives from November 2002

Protections for interim treatment comparison plus monitoring definitions seen in final FDA guidance. (DMCs/monitoring).
November 1, 2002... TORONTO -- FDA may soon end the controversy and speculation around data monitoring committees (DMCs) with a final guidance that will primarily deal with issues about whether review of data by a DMC (which are mostly paid by sponsors) would bias...

Consent form violations found in 78% of OHRP site visits, half in initial review process. (Informed consent).
November 1, 2002... About 78% of the IRB site visits conducted by the Office of Human Research Protections (OHRP) in recent fiscal years had problems with consent forms, and nearly half of the deficiencies are in either the initial review process or in informed...

Canada sees 100% jump in trial applications in year since adopting quicker review rules. (Clinical trials).
November 1, 2002... TORONTO -- Canada's Therapeutic Products Directorate (TPD) has received nearly double the number of "clinical trial applications" (CTAs) in the year since enacting streamlined review regulations and has been approving most bioequivalence/...

When to use a DMC, and when not to ... (DMCs).
November 1, 2002... TORONTO -- Not all trials have the same risks and therefore, not all require the same monitoring parameters, experts told the AAPS meeting here. So, DMCs are probably not needed in all studies. From an FDA standpoint, DMCs are still not...

CRO, IRB, investigator liability in trials increasing; accreditation might abate suits. (Liability).
November 1, 2002... CROs, IRBs and principal investigators (PI) face increased legal liability largely because institutions and researchers are not familiar enough with FDA BiMo regulations, an attorney with a top food and drug law firm told FDLI Nov. 12. ...

Computer, software problems noted in Lilly GLP lab audit. (GLP).
November 1, 2002... Eli Lilly Research Laboratory, Greenfield, IN, Detroit District Computer and software problems, mostly in record retrieval, were noticed in a pair of back-to-back GLP audits of Eli Lilly's Greenwood, IN, lab, according to inspection...

Omissions in informed consent for parents, missing source documents, and discrepancies in CRFs triggers seven-item 483. (Clinical investigators).
November 1, 2002... Robert Block, M.D., Chair, Pediatrics Department, University of Oklahoma Health Sciences Center, Norman, OK FDA cracked down hard on Robert Block, M.D., regarding problems in informed consent, missing source documents and discrepancies in...

Numerous protocol deviations, undocumented lab and lack of sponsor monitor result in 483.
November 1, 2002... William Chey, M.D., Konar Center for Digestive and Liver Diseases, Strong Memorial Hospital, University of Rochester Medical Center, Rochester, NY Deviations in protocol prompted the Center for Drugs to initiate this high priority user-fee...

Warning letters.
November 1, 2002... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs, which were released in October 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 12069W). Copies...

BiMo FOIA log.
November 1, 2002... This is a list of FOIA requests for copies of 483s and EIRs for inspections of CROs, testing labs, IRBs and clinical investigators, filed with FDA under the Freedom of Information Act (FOIA). This list does not imply that a 483 or EIR has been...

IRB determination letters.
November 1, 2002... The following are Compliance Determination letters for IRBs issued in October 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...