Bioresearch Monitoring Alert articles from February 2005

Bioresearch Monitoring Alert archives from February 2005

FDA to hold hearing on reporting AEs to IRBs.(Adverse events/IRBs)(Food and Drug Administration)(Adverse Events)(International Rugby Board)
February 1, 2005... FDA has scheduled a formal Part 15 hearing on March 21 to discuss ways of reforming the way adverse events are submitted to IRBs. According to a Feb. 8 "Federal Register" notice, the all-day meeting, to be held at agency headquarters in...

PWC consultant urges single agency, regulatory changes in subject protection.(Human subject protection)(PricewaterhouseCoopers)
February 1, 2005... ALEXANDRIA, VA -- The public's negative view of human subject research, combined reporting in the industry, with resistance to self-reporting in the industry, means that changes are needed in the regulations, including the creation of a single...

SACHRP subcommittee recommends uniform standard for definition of 'minimal' risk.(Pediatric research)(SecretaryEs Advisory Committee on Human Research Protections)
February 1, 2005... LEXANDRIA, VA -- A proposal by a SACHRP subcommittee recommended Jan. 31 that IRBs should apply a uniform standard for the definition of "minimal risk" under HHS regulations, "Additional Protections for Children Involved as Subjects in...

SACHRP subcommittee looking to reduce regulatory burden of Subpart A.(Subject protection)(Secretary's Advisory Committee on Human Research Protections)
February 1, 2005... ALEXANDRIA, VA -- A new SACHRP subcommittee, formed in October 2004 to review and provide recommendations for Subpart A of 45 CFR 46, is eying ways to reduce regulatory burden "that does not contribute to the protection of human subjects,"...

ORI has no direct responsibility for OHRP or FDA compliance, but jurisdictions can overlap.(Research fraud)(Office of Research Integrity)(Office for Human Research Protections)(Food and Drug Administration)(Brief Article)
February 1, 2005... ALEXANDRIA, VA -- Despite the fact it only has purview over federally funded research, the HHS Office of Research Integrity's (ORI) jurisdiction can overlap with OHRP and FDA, and cases can be referred back and forth and information shared. ...

Hopkins reflects on lessons learned from clinical study death.(Clinical trials)
February 1, 2005... ALEXANDRIA -- After the death of a 21 year-old woman in a clinical study in 2001, the Johns Hopkins University School of Medicine's MPA was suspended; and the facility instituted a corrective action plan that included a re-review of all IRB...

7-item 483 for 510(k) data issues put Diagnostic Products on AIP list.(Sponsors/monitors)(application integrity protocol)
February 1, 2005... Diagnostic Products Corporation, Los Angeles, Los Angeles District Inconsistencies in records and documentation, including inaccurate documentation referenced in the 510(k) submission and inconsistent patterns in patient history files...

American Cardiovascular Research hit with 24-item 483, including failures in QA, protocol violations, not following GLP regs.(GLPs/clinical investigators)(Good Laboratory Practice)(American Cardiovascular Research Institute )
February 1, 2005... American Cardiovascular Research Institute, Norcross, GA, Atlanta District American Cardiovascular Research Institute (ACRI), Norcross, GA, was cited in a 24-item 483 for multiple QA failures, not following study protocol and ignoring Good...

Jezbera earns a clean report from FDA on 2nd inspection.(GLPs/clinical investigators)
February 1, 2005... Edward Jezbera, D.V.M, Riverside, CA, Los Angeles District Edward Jezbera, D.V.M., received no 483 following an FDA inspection at Riverside Animal Hospital in Riverside, CA. Investigators John Gonzalez and Mark Saale from the Los Angeles...

Siler nets 3-item 483 for AE reporting failures; study coordinator praises agency.(GLPs/clinical investigators)(Adverse Event Report )
February 1, 2005... Thomas Siler, M.D., St. Charles, MO, Lenexa, KS District Thomas Siler, M.D., Midwest Chest Consultants, did not report adverse events and other unanticipated problems to the IRB in a prompt manner, netting him a 3-item 483. The...

NIDPOE letters.
February 1, 2005... The following is a Notice of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) letter. NIDPOEs are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval. Note: A NIDPOE letter informs the recipient...

Warning letters.
February 1, 2005... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in December 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W,...

IRB determination letters.
February 1, 2005... 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...

BiMo FOIA log.(Freedom Of Information Act)(Environmental Impact Report)
February 1, 2005... 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...