Bioresearch Monitoring Alert articles from June 2002

Bioresearch Monitoring Alert archives from June 2002

CBER to create office-level group to handle cells, gene therapy, tissue, BiMo staff to stay put; attorney Milstein critical of gene therapy.(Center for Biologics)(Brief Article)
June 1, 2002... BETHESDA, MD - Perhaps in response to growing concerns over clinical trials involving cell and gene transfers, FDA's Center for Biologics Oct. 1 is expected to create a new "Office of Cells, Tissues and Gene Therapy." The announcement...

Over 73% of providers have no policies on 'exposure' of private records, accessing 'minimally necessary' data, HCCA poll says.(Health Care Compliance Association survey of health care providers)(Brief Article)(Panel Discussion)(Statistical Data Included)
June 1, 2002... CHICAGO - About 76% of health care providers have no policy to address potential exposure of protected health information through viewing, paging and other The survey, released here at HCCA's recent annual compliance institute, also shows...

Training necessary down to staff level, hospital officials say.(Brief Article)
June 1, 2002... CHICAGO - Research institutions and others covered by HIPAA should designate a privacy officer now and do necessary staff training and hospital board training before the April 2002 implementation date for the federal privacy rules. ...

Privacy notices could be liability traps, attorney says.(Brief Article)
June 1, 2002... CHICAGO - The HIPAA-required "privacy notice" could be a liability trap, particularly if wording conflicts with state privacy laws, an attorney told HCCA. Ryan Meade, partner with the law firm Michael Best & Friedrich of Chicago, also...

How one hospital took on HIPAA and 'PHI' - U. of Michigan Health System.(Health Insurance Portability and Accountability Act; protected health information)(Brief Article)
June 1, 2002... CHICAGO - How do you prepare for HIPAA when health care is not the main business of your organization? What happens when health care providers are scattered throughout your organization, reporting to administrators who do not always know what...

Firm receives stern slap for initiating studies despite warning letter ordering it to fix problems first.(Coulston Foundation)(Brief Article)
June 1, 2002... Coulston Foundation, Alamogordo, NM, Denver District The Coulston Foundation received an eight-page 483 and subsequent warning letter after a Nov.-Dec. 2000 inspection of its Alamogordo, NM, facility. The letter gives Coulston a matching...

Employee claims, study deaths spark inspections.(TherImmune Research Corp.)
June 1, 2002... TherImmune, Gaithersburg, MD, Baltimore District Deaths of study subjects prompted FDA to send an inspection team to visit Maryland-based CRO TherImmune. FDA inspector David Glasgow of the agency's Baltimore District Office and CDER...

Mystery surrounding animal substitutions remains unsolved.(Brief Article)
June 1, 2002... Experimental Pathology Laboratories, Research Triangle Park, NC, Atlanta District Although punctuated by a 483, an inspection of an Experimental Pathology Laboratories (EPL) facility in Research Triangle Park, NC, proved largely...

Sponsor/monitor's observations, study termination prompt FDA inspection.(at the Metrowest Medical Center, Natick, MA)(Brief Article)
June 1, 2002... Stanley Cheren, M.D., Metrowest Medical Center, Natick, MA, New England District Site audits by a sponsor/monitor led to the discontinuation of a trial conducted by Stanley Cheren, M.D., of Metrowest Medical Center. The action prompted...

Failure to document disposition of test article a bump in investigator's inspection road.(at the Southern California Research Center, Mission Viejo, CA)(Brief Article)
June 1, 2002... William Berger, M.D., Southern California Research Center, Mission Viejo, CA, Los Angeles District A study of a drug already approved for other indications was the focal point of an FDA inspection of William Berger, M.D., of the Southern...

Investigator fares well despite informed consent lapse.(Brief Article)
June 1, 2002... Andrew Lewin, M.D., National Research Institute, Los Angeles, CA, Los Angeles District Clinical investigator Andrew Lewin, M.D., is on a two-inspection streak after a March 2000 visit garnered him a second straight thumbs up from FDA. A...

Warning Letters.(Food and Drug Administration)(Brief Article)
June 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/ monitors and CROs and testing labs that FDA released since May 10, 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e.,...

BiMo FOIA Log.
June 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.
June 1, 2002... The following are Compliance Determination Letters for IRBs issued in May by the HHS Office of Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related to these letters also are available by calling...