Bioresearch Monitoring Alert articles from January 2003

Bioresearch Monitoring Alert archives from January 2003

Sen. Frist seen key to whether IRB legislation passes in new Congress. (Human subject protection).
January 1, 2003... Whether the clinical research community will see any action on federal human subject protection legislation, and thus mandatory or voluntary IRB certifications, may depend on the support (or lack thereof) by incoming Senate Majority Leader Bill...

Oncologists, subjects differ on purpose of clinicals, but consent forms not to blame. (Informed consent).
January 1, 2003... A new survey of oncologists shows that cancer patients in clinical trials believe the primary intent of the study is not to determine the efficacy of a drug or device, but to get cutting-edge care. Steven Joffe, M.D. and Jane Weeks, M.D. of...

Sponsor audits suggested as IRBs become swamped. (Sponsors).(IRB Biomed)
January 1, 2003... RANCHO BERNARDO, CA -- Amid the volume of clinical trials and an increasingly complex maze of regulatory requirements, the role of the IRB often has become obscured, so sponsors should do more auditing than just the mandatory "monitoring" as...

8-step approach suggested for sponsors to audit CROs. (CROs).(contract research organization)
January 1, 2003... RANCHO BERNARDO, CA -- An audit doesn't have to be a negative experience, so says Heidi Boorstein of Quintiles. She told a Center for Pharmaceutical Technology (CPT) meeting here Dec. 11, that her first audit was the best learning...

How audits can actually help a business. (Auditing).
January 1, 2003... ORLANDO -- Audits can strike fear in the hearts of pharmaceutical professionals, sometimes even for the auditors. But by abandoning such antiquated gloom and doom scenarios, businesses can give way to more effective audits, improved drug...

Study coordinator complaint triggers four-month audit, resulting in 12-page 483. (Clinical investigators).
January 1, 2003... Robert Heinig, M.D., Rochester General Hospital, Rochester, NY, New York District This four-month for-cause BiMo investigation of Robert Heinig, M.D. of Rochester General Hospital, was initiated by a complaint filed by study coordinator...

Protocol deviations, documentation and informed consent inadequacies land PI seven-item 483. (Clinical investigators).(St. Jude Children's Research Hospital)
January 1, 2003... Richard Heideman, M.D., St. Jude Children's Research Hospital, Memphis, TN, New Orleans District This for-cause inspection was prompted by complaints by two former St. Jude physicians, and was conducted in conjunction with an OHRP audit....

Exclusion/inclusion criteria and informed consent issues bring on 483. (Clinical investigators).
January 1, 2003... Justus Fiechtner, M.D., Fiechtner Research P.C., East Lansing, MI, Detroit District Sloppy records and disregard for inclusion and exclusion criteria earned Justus Fiechtner, M.D., of Fiechtner Research P.C., a four-item 483 following his...

Subjects failed to meet protocol inclusion requirements; included anyway. (Clinical investigators).
January 1, 2003... Alice Chenault, M.D., Huntsville Research Associates, Huntsville, AL, New Orleans District Several protocol deviations resulted in a three-item 483 for this user fee initial inspection for Alice Chenault, M.D., of Huntsville Research...

Informed consent document fails to reflect risks. (Clinical investigators).
January 1, 2003... Robyn Barst, M.D., Babies and Children's Hospital at Columbia Presbyterian Medical Center, New York, NY, New York District FDA came knocking on the door of clinical investigator Robyn Barst, M.D. to inspect records from a study that focused...

BiMo FOIA log.(Freedom of Information Act)(Brief Article)
January 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...

NIDPOE letters.
January 1, 2003... The following "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain" (NIDPOE) letter was issued by the CDER Office of Medical Policy to the clinical investigator regarding his conduct of clinical studies. This and...

Warning letters.(Brief Article)
January 1, 2003... The following are FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs, which were released in December 2002. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (i.e., 12069W)....

IRB Determination letters.(Brief Article)
January 1, 2003... The following are Compliance Determination letters for IRBs issued in late November and December by the Department of Health and Human Services Office for Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents...