Bioresearch Monitoring Alert articles from April 2003

Bioresearch Monitoring Alert archives from April 2003

Lepay sees closer FDA-OHRP ties with Schwetz as office head; IRB compliance program to be revised, BiMo audits prioritized. (Compliance/enforcement).
April 1, 2003... PHILADELPHIA -- FDA and the Office of Human Research Protections (OHRP) will likely work more closely on enforcing human subject research protections and Good Clinical Practices (GCP) now that Bernard Schwetz, Ph.D., is acting director of the...

OHRP head advises protocol approval from IRBs in advance for emergencies. (Clinical trials).
April 1, 2003... The new acting director of OHRP, Bernard Schwetz, Ph.D., April 2, advised sponsors and researchers to get IRB approval of protocols first before actually getting approval from ethics boards to begin enrolling patients. In addition,...

FDA inspectors disclose means of doing BiMo audits, suspect too good documentation. (BiMo inspections).
April 1, 2003... PHILADELPHIA -- FDA inspectors conduct for-cause audits out of suspicion of misconduct, but it is not always clear what constitutes "suspicious." At the ACRP annual meeting here April 6, Khin Maung U, chief supervisory medical officer of...

Auditing is QA, monitoring QC, both needed, Konnor says. (Monitoring/auditing).
April 1, 2003... Although FDA only requires monitoring of clinical trials, not auditing, trial sponsors should do such audits because monitoring is more a quality control mechanism and auditing is quality assurance. That was the advice of Charma Konnor,...

FDAer urges sponsors to cultivate whistle blowers, not fear reporting to FDA. (Sponsor/monitors).
April 1, 2003... PHILADELPHIA -- A senior FDA BiMo enforcement official suggested here April 9 that clinical research sponsors cultivate whistle blowers to turn in trial personnel who are allegedly committing fraud and misconduct. Stan Woollen, FDA's...

Dartmouth-Hitchcock, Harvard-Lahey IRBs conflict on how they handle adverse events. (Data Monitoring/IRBs).
April 1, 2003... BURLINGTON, MA -- Dartmouth-Hitchcock Medical Center's IRB will not approve a study unless it has an adequate data safety monitoring (DSM) plan, but its board will only review serious or unanticipated experiences, while the Lahey Clinic of...

GLP audit finds firm mostly in compliance except for documentation errors. (GLP).
April 1, 2003... Covance Laboratories, Madison, WI, Minneapolis District FDA inspector Ronald Ruff of the Minneapolis District, found Covance Labs' Madison, WI, facility mostly in compliance for this directed GLP data audit inspection, but a 483 was still...

Investigator serving as sponsor not aware of his duties; racks up 20-item 483. (Clinical investigators).
April 1, 2003... Walter Holder, M.D., Carolinas Medical Center, Charlotte, NC, Atlanta District This initial inspection for Walter Holder, M.D., did not bode well--he was slapped with a 20-item 483 following the 10-day audit. Holder, who was both the...

CI racks up 17-item 483 for lost and missing informed consent docs in vaccine study. (Clinical investigators).
April 1, 2003... Eddy Hsueh, M.D., John Wayne Cancer Institute, Santa Monica, CA, Los Angeles District Clinical investigator Eddy Hsueh, M.D., received a whopping 17-item 483 following his initial FDA inspection in March 2002, though he inherited the Stage...

Outdated consent form, lost CRF land CI 483. (Clinical investigators).
April 1, 2003... David Hassman, D.O., Comprehensive Clinical Research, Berlin, NJ, New Jersey District FDA slapped David Hassman, D.O., with a five-item 483 for violations that included out-of-date consent forms, a missing CRF, patients included in the...

CI feels wronged by sponsor, monitors; audit reveals improprieties. (Clinical investigators).
April 1, 2003... Sameer Mehta, M.D., Cedars Medical Center, Miami, FL, Florida District FDA came knocking on the doors of Sameer Mehta, M.D., for a for-cause inspection, and Mehta's initial inspection in March and April 2002. According to FDA records,...

Warning letters.
April 1, 2003... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs, which were released March 10, 17, 24 and 31, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g.,...

BiMo FOIA log.(Brief Article)
April 1, 2003... 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...