Bioresearch Monitoring Alert articles from November 2001

Bioresearch Monitoring Alert archives from November 2001

CDRH to do random surveillance audits of investigators, IRBs.(Center for Devices)(Brief Article)(Statistical Data Included)
November 1, 2001... BALTIMORE - FDA's Center for Devices will soon start conducting random inspec-tions of clinical investigators and IRBs in order to determine trends in violations of bioresearch monitoring requirements, the Center's chief said Nov. 6. ...

Hopkins sanctions scientist for violation of FDA, university requirements.(Johns Hopkins University, Ru Chih Huang)(Brief Article)
November 1, 2001... A scientist at Johns Hopkins University in Baltimore has been sanctioned for testing experimental cancer drugs on patients in India without obtaining the required federal or university approvals, including FDA export clearance and an...

20% of ORI cases involve misconduct; new definition to include 'reckless disregard'.(Office of Research Integrity)(Brief Article)
November 1, 2001... McLEAN, VA - The Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services estimates that about 20% of the active cases it has under review involve misconduct, meaning researchers could be barred from getting...

Sponsors need to evaluate contractors for Part 11 compliance.(electronic signatures at issue)(Brief Article)
November 1, 2001... SAN FRANCISCO - Sponsors of drug and device studies had better work into their CRO/contract lab agreements ways that contractors will abide by 21 CFR Part 11, FDA's electronic signature/records regulation, says an Amgen executive. "The...

FDAers say mistakes can be forgiven, just let documents be copied.(Brief Article)(Statistical Data Included)
November 1, 2001... BALTIMORE - FDA inspections can intimidate even the most fastidious of clinical investigators, sponsor/monitors, IRBs and CROs. At the Nov. 5-7 Regulatory Affairs Professionals Society (RAPS) annual meeting here, FDA officials and an...

1% of U.K. clinicals could have integrity problems.(clinical research)(Brief Article)(Statistical Data Included)
November 1, 2001... McLEAN, VA - About 1% of all clinical research conducted in Britain could be subject to data integrity or misconduct problems, which is about what it is in the U.S. However, the numbers could bolster arguments that FDA should do more foreign...

IRB receives clean bill of health six years after 483.(Eisenhower Medical Center)(Brief Article)
November 1, 2001... Eisenhower Medical Center Institutional Review Board, Rancho Mirage, CA, Los Angeles District The IRB at Eisenhower Medical Center, Rancho Mirage, CA, fared well in an inspection that concluded Nov. 8, 2001. In an interview, IRB chairman...

483 for gene therapy researcher focuses on protocol deviations.(Tapas Das Gupta)
November 1, 2001... Tapas Das Gupta, M.D., University of Illinois at Chicago, Chicago, IL, Chicago District A 483 write-up of Chicago-based Clinical Investigator Tapas Das Gupta, M.D. cited eight violations ranging from the gene therapy researcher's lack of...

Primedica admits to lapses in storage, documentation.(Brief Article)
November 1, 2001... Primedica Corporation, Worcester, MA, New England District An FDA inspection of Primedica, a Worcester, MA-based international CRO and subsidiary of Genzyme (Framingham, MA) yielded several storage-related problems and two documentation...

BiMo FOIA Log.
November 1, 2001... 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)
November 1, 2001... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/ monitors and CROs and testing labs since July 1, 2001. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 11052W, etc.). Copies...

IRB Determination Letters.
November 1, 2001... The following are Compliance Determination Letters for IRBs issued in October by the National Institutes of Health Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters also...