Bioresearch Monitoring Alert articles from November 2003

Bioresearch Monitoring Alert archives from November 2003

FDA, OHRP to craft joint rules to register IRBs; house and senate legislation forthcoming.(IRBs)(Office for Human Research Protections)(Food and Drug Administration)
November 1, 2003... BALTIMORE -- FDA and the Office for Human Research Protections (OHRP) are closer to issuing a joint regulation for registering IRBs, but not requiring mandatory accreditation, as bills in both houses to revise the nation's human subject...

Bush considers new law to ensure medical records privacy.(HIPAA)
November 1, 2003... CHICAGO -- U.S. Treasury Department is working behind the scenes with Congress to craft a law on medical information privacy, a measure that could dramatically affect pharmaceutical manufacturers and research hospitals. Assistant...

EU GCP directive to go into force in May despite gaps in member states.(International)(good clinical practice)(European Union)
November 1, 2003... BALTIMORE -- Once the European Union (EU) Directive on GCP in Clinical Trials goes into force next May, researchers will not only have to know the European Commission (EC) guidelines, but each member state's regulations as well. Dianne...

Inadequate ICH GCP training hurts multi-site global trials.(Clinical investigators)(International Conference on Harmonisation)( good clinical practice)
November 1, 2003... BALTIMORE -- Inconsistent training and improper selection of investigators account for most non-compliance discovered at multi-site global clinical trials, a consultant and clinical investigator trainer told the RAPS annual meeting here Oct....

Latin American GCP monitoring guide wending way toward adoption.(Monitoring)(Good Clinical Practices)
November 1, 2003... BALTIMORE -- A harmonized guidance document on doing GCP compliance monitoring in Latin America was adopted in Mexico in August and could be finalized next year, along with another document on clinical investigator inspections, a top FDA BiMo...

New Editorial Advisory Board selected for BioResearch Monitoring Alert.(Brief Article)
November 1, 2003... Dear Subscribers: Washington Information Source Co. has named three distinguished experts in the field of clinical research compliance and HIPAA to serve on its editorial advisory board for BioResearch Monitoring Alert. They are: ...

HIPAA information security rules go live in 2005.(Health Insurance Portability and Accountability Act of 1996)
November 1, 2003... CHICAGO -- Rules requiring information security for electronic medical records kept per HIPAA of 1996 require compliance by April 21, 2005, but many research hospitals may have already substantially complied with them before that date, Linda...

FDA finds little to fault despite two audits in eight months.(GLPs)(Food and Drug Administration)(Pfizer Groton Laboratories)
November 1, 2003... Pfizer Groton Laboratories, Groton, CT, New England District A team comprised of FDA investigator Anthony Warchut and toxicologists John Welsh, Catherine Whiteside and T. Scott Thurmond from the New England District descended upon...

IRB audit reveals startling omissions in written procedures.(IRBs)(Fairview Hospital IRB)
November 1, 2003... Fairview Hospital IRB, Cleveland, OH, Cincinnati District Karen Kondas from FDA's Cincinnati District discovered several serious deficiencies in written and operating procedures during an audit of the Fairview Hospital IRB, Cleveland, OH,...

CI fails to account for medical devices, maintain IRB approval.(Clinical investigators)(Orthopedic Specialties of Tampa Bay)
November 1, 2003... Michael Piazza, M.D., Orthopedic Specialties of Tampa Bay, Clearwater, FL, Florida District. Florida District's Virginia Meeks slapped Michael Piazza, M.D., of Clearwater, FL, with a three-item 483 for failure to maintain records of...

Attention to detail pays off for initial CI inspection.(auditing of Cedars-Sinai Comprehensive Cancer Center, Los Angeles)(clinical investigators)(Brief Article)
November 1, 2003... Ronald Natale, M.D., Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA, Los Angeles District Ronald Natale, M.D., breezed though his initial FDA inspection at the Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA, where he...

Warning letters.(Food and Drug Administration warning letters to clinical investigators)
November 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Oct. 20 and 27 and Nov. 3 and 17, 2003. Each letter is $7 plus retrieval. Please order by...

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

BiMo FOIA log.(Freedom of Information Act)
November 1, 2003... 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...