Bioresearch Monitoring Alert articles from April 2002

Bioresearch Monitoring Alert archives from April 2002

Privacy board suggested despite proposed HIPAA rule changes.(Health Insurance Portability and Accountability Act )(Brief Article)
April 1, 2002... PHILADELPHIA - Despite proposals by the Bush administration to relax some facets federal privacy rules under the Health Insurance Portability and Accountability Act (HIPAA), an attorney recommended that institutions still have a "privacy...

RECAP: Kennedy to hold April 23 hearing on patient protection; bills to revamp laws forthcoming.(Edward Kennedy)(Brief Article)
April 1, 2002... The following are abbreviated versions of breaking news from our weekly online news page, which is free to all subscribers. If you are not receiving these free news updates, please send your e-mail address to editors@FDAINFO.com To read the...

HHS I.G. examining Web-based clinical trial sites.(Inspector General)(Brief Article)
April 1, 2002... The HHS Inspector General in June might issue a report critiquing Web-based clinical trial sites that handle informed consent, an I.G. official said March 25 at the Medical Research Summit conference in Washington. Mark Yessian, Ph.D.,...

New ISO standard could affect FDA review of foreign device clinicals.(Brief Article)
April 1, 2002... McLEAN, VA - A final standard is about to go into effect that FDA could use to gauge whether foreign clinical trials for new medical devices abided by the document's precepts regarding informed consent, study auditing and reporting of adverse...

Intimidation by male investigators and 'phantoms' blamed; getting to know sites suggested.(study monitors)
April 1, 2002... PHILADELPHIA - Being a study monitor can be a tough job, particularly if you're young, female and have the distinction of stepping in a pile of research fraud or non-compliance and don't know how to bring it to the attention of the alleged...

Firms issue responses to DMC guidance; many cite concern over FDA's statistician recommendations.(data monitoring committees)
April 1, 2002... The Johns Hopkins Center for Clinical Trials and Genzyme were among the many groups to respond to FDA's draft guidance on data monitoring committees (DMCs). Comments ranged from broad to specific, with one firm questioning use of the name "data...

After warning letters for sponsor/monitor, clinical investigator, human trials resume at Garden State.
April 1, 2002... Garden State Cancer Center, Belleville, NJ, New Jersey District Physicians at the Garden State Cancer Center have begun to screen patients for two upcoming cancer trials. This might be deemed routine at another location, but the trials...

IRB receives multiple hits for insufficient SOPs, failure to ensure compliance.(Cooper Hospital University Medical Center, standard operating procedures)(Brief Article)
April 1, 2002... Cooper Hospital University Medical Center, Camden, NJ, New Jersey District A February 2000 inspection of Cooper Hospital University Medical Center's IRB offered both good news and bad for the institution. The good news was that, as...

Failure to report adverse events, other lapses net dermatologist 483.(Amy Paller)(Brief Article)
April 1, 2002... Amy Paller, M.D., Children's Memorial Hospital, Chicago, IL, Chicago District A data audit of a Chicago-based dermatologist, conducted under FDA's user fee review rules, resulted in citations for several transgressions including deviations...

Deviation from protocol, records cited by FDA.(Richard Sturm)(Brief Article)
April 1, 2002... Richard Sturm, M.D., Long Island Ophthalmic Surgery, Lynbrook, NY, New York District Clinical investigator Richard Sturm, M.D. started the millennium with a two-item citation for a deviation from protocol and records discrepancies. This...

Firm undergoes three inspections, nets two 483s.(HTI Bio-Services)
April 1, 2002... HTI Bio-Services (also D.B.A. Sierra Biomedical), San Diego, CA, Los Angeles District HTI Bio-Services' most recent inspection netted the firm a 483, after two previous inspections that also discovered problems, according to recently...

BiMo FOIA Log.(Brief Article)
April 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...

Warning Letters.(Brief Article)
April 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 9007W, 9008W, etc.). Copies of responses...

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