Bioresearch Monitoring Alert articles from July 2002

Bioresearch Monitoring Alert archives from July 2002

Assistant U.S. attorney sees more cases involving researcher/industry financial ties. (Financial disclosure).
July 1, 2002... WARREN, NJ -- Federal regulators are focusing more on financial conflict of interest by clinical researchers, and a federal prosecutor said here June 12 that financial conflict of interest marks ground "where law enforcement and industry will...

I.G. suggestion for web-based trial standards by FDA, OHRP could mean more paperwork for overtaxed IRBs. (Web-based trials).
July 1, 2002... A recent report on Web-based clinical trial sites by the Office of the Inspector General (I.G.) of the Department of Health and Human Services could result in more work being dropped on overtaxed IRBs if the I.G. recommendations are carried...

Koski urges end to finders fees, challenges doctors to establish code. (Ethics).
July 1, 2002... CHICAGO -- The director of the Office of Human Research Protections (OHRP) urged the end of "finders fees" for new patients, and challenged associations representing physicians to write guidelines for ethics in research. Greg Koski, M.D.,...

Research horror stories don't start and end with fraud, some say. (Fraud/Misconduct).
July 1, 2002... CHICAGO -- Incomplete IRB meeting minutes, reports thrown in the garbage without management knowledge, and cases of rounding off blood pressure readings were among horror stories that a variety of study auditors and consultants disclosed at...

Central IRB or 'research office' at institutions urged.
July 1, 2002... CHICAGO -- Another prominent member of the research community has chimed in on the need for research institutions to have a centralized IRB or "research office" to coordinate multi-center trials. Lewis Smith, M.D., of Northwestern...

Documentation lapses, conflicting records, audit trail hiccups result in firm's third 483 in as many months. (GLPs).
July 1, 2002... Covance Laboratories, Vienna, VA, Baltimore District A team comprised of CDER pharmacologist Jacqueline O'Shaughnessy and David Glasgow of FDA's Baltimore District Office uncovered several protocol lapses, as well as incomplete archives,...

Failure to follow protocol accounts for majority of hits for GLP facility. (GLPs).
July 1, 2002... Pharmacia, Skokie, IL, Chicago District Despite having the advantage of a heads up on FDA's arrival for an audit, Pharmacia was taken to task for a number of lapses, primarily related to animal studies. Two toxicity studies submitted in...

Subject presented consent forms morning of surgery; investigator draws 483. (Clinical investigators).
July 1, 2002... "Serious and numerous deficiencies" were uncovered by New York District Office inspectors L. Glenn Massimilla and Andrew Paglia, resulting in a 15-item 483 for clinical investigator Mark Figgie, M.D, of the Hospital for Special Surgery in New...

PI Isaacsohn shows how it's done in picture-perfect inspection. (Clinical investigators).
July 1, 2002... A pivotal study of a cholesterol-reducing agent brought FDA to the doors of Cincinnati's Metabolic and Atherosclerosis Research Center in July 2000. The two-day inspection, focused on clinical investigator Jonathan Isaacsohn, M.D., was...

Inspection highlighted by regulatory compliance. (Clinical investigators).
July 1, 2002... Julio Rosenstock, M.D., was on hand to provide study records to and answer questions posed by Phillip Waldron, an inspector with FDA's Dallas District Office. The five-day visit went well for the clinical investigator, whose previous visit,...

BiMo FOIA log.
July 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.
July 1, 2002... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs June 3, 10, 17 and 24, 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 9007W, 9008W,...