Bioresearch Monitoring Alert articles from March 2003

Bioresearch Monitoring Alert archives from March 2003

Drug sponsors audited less than device firms, in part due to whistleblowing, GCP knowhow. (Sponsor/monitors).
March 1, 2003... Although the Center for Drugs receives more new drug applications (NDAs) than the Center for Devices gets in way of premarket approval (PMA) applications, CDRH inspects six times more sponsors largely because device manufacturers are generally...

Boards at compliance risk with 'expedited' reviews if continuing review is lacking. (IRBs).
March 1, 2003... IRBs are at greater risk of OHRP and FDA non-compliance when doing "expedited reviews," particularly if they ignore the continuing review of studies, consultants and FDAers told the Medical Research Summit meeting in Washington, March 5-7. ...

AAHRPP to keep accreditation denials, even patient risks, confidential. (Accreditation).
March 1, 2003... The fledgling Assn. for Accreditation of Human Research Protection Programs (AAHRPP), which provides a "gold seal" of approval to institutions and clinical investigators who undergo the group's accreditation process, will not disclose to the...

How to jump-start your HIPAA compliance program. (HIPAA).
March 1, 2003... There is still hope for research institutions that haven't begun to get ready for the approaching April 14 HIPAA deadline, but they will need to follow a quick action plan, such as one laid out by Steven Lazarus, Ph.D., president of the...

Western IRB gets 483 for legacy system, but is upgrading to 'IRIS'. (IRBs).
March 1, 2003... Western Institutional Review Board, Olympia, WA, Seattle District Western Institutional Review Board (WIRB) received a two-item 483 last year concerning Part 11 issues related to a legacy system that lacked audit trails, among other issues,...

Sloppy meeting minutes racks up 483 items for IRB.
March 1, 2003... Childrens Hospital--San Diego Institutional Review Board, San Diego, CA, Los Angeles District Inadequate informed consent forms, procedures for full IRB board review not being followed, incomplete records and many deviations related to...

Failure to correct problems from earlier audit lands 483. (GLP).
March 1, 2003... American Health Foundation, Valhalla, NY, New York District American Health Foundation (AHF), Valhalla, NY, failed to correct numerous deficiencies discovered in a 1997 inspection despite the fact that a warning letter was issued and the...

Experience pays off in form of smooth audit. (Clinical investigators).
March 1, 2003... Robert Kaufmann, M.D., Southeastern Fertility Center, Mt. Pleasant, SC, Atlanta District Some minor discrepancies in drug accountability and record keeping of patient records were cited in a recent audit of Robert Kauffman, M.D., of...

FDA inspects retired CI five years after study concludes.
March 1, 2003... Donald O'Hair, Ph.D., Centre for Clinical Research, San Diego, CA, Los Angeles District FDA conducted a November 2001 inspection of Donald O'Hair, Ph.D, director of the Centre for Clinical Research, San Diego, CA, although the study had...

Thorough audit reveals only a few minor errors.
March 1, 2003... Norman Zinner, M.D., Western Clinical Research, Torrance, CA, Los Angeles District Norman Zinner, M.D., medical director of Western Clinical Research, Torrance, CA, fared well and no 483 was issued for this CI/data audit inspection, which...

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

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

Untitled letters.
March 1, 2003... The following untitled letters were issued by the Division of Bioresearch Monitoring of the Center for Devices, Office of Compliance (CDRH-OC) in 2002. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus...

BiMo FOIA log.(Directory)
March 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...