Bioresearch Monitoring Alert articles from February 2003

Bioresearch Monitoring Alert archives from February 2003

CDER BiMo audits to increase, but CBER, CDRH to see decline in '04; OHRP budget cut. (Inspections).(Bioresearch Monitoring, Office of Human Research Projections)
February 1, 2003... Despite telling Congress that "an effective, comprehensive Bioresearch Monitoring (BiMo) program is essential for the expeditious development and licensing of safe and effective products and to ensure patient safety," FDA BiMo inspections will...

HHS adopts final security standards for electronic protected health info under HIPAA. (HIPAA).(Department of Health and Human Services, Health Insurance Portability and Accountability Act)
February 1, 2003... Just when researchers were beginning to get their arms around HIPAA, the Department of Health and Human Services (HHS) Feb. 13 adopted final security standards for protecting individually identifiable health information when it is maintained or...

IRBs not seen ready for HIPAA rule; privacy boards not seen in great number. (HIPAA/IRBs).
February 1, 2003... Although most IRBs are already overburdened with FDA and other federal requirements, many are soon to be saddled with the responsibility of ensuring that their institutions are compliant with the Health Insurance Portability and Accountability...

'De-identifying' information could help make HIPAA bite less; other means suggested. (HIPAA).
February 1, 2003... By removing 18 identifiers from personal health information gathered in clinical trials, or by determining "use" of such data and how it will be disclosed, clinical trial overseers (notably IRBs) might be able to minimize disruptions when the...

Despite Part 11, other issues, Aventis dodges 483 in GLP audit. (GLP).(Aventis Pharmaceuticals)
February 1, 2003... Aventis Pharmaceuticals, East Millstone, NJ, New Jersey District Although Aventis Pharmaceuticals escaped a 483, a lengthy list of deviations were uncovered during the inspection, which included water testing issues, validation of the EKG...

Significant errors, including failure to report serious adverse event, triggers four-item 483. (Clinical investigators).
February 1, 2003... Suyu Shu, Ph.D., Cleveland Clinic Foundation, Cleveland, OH, Cincinnati District Serious deviations including failure to report a serious adverse event to FDA and the IRB, as well as screening subjects without consent forms, landed Suyu...

FDA inspector cuts no slack with blood sample monitoring. (Clinical investigators).
February 1, 2003... Hector Rodriguez, M.D., Ph.D., medical director, Tower Gambro Dialysis, Beverly Hills, CA, Los Angeles District Hector Rodriguez, M.D., Ph.D., was not present for his initial FDA inspection conducted by Paquita Segarra of the Los Angeles...

Investigator used Spanish consent form not approved by IRB. (Clinical investigators).
February 1, 2003... Chandra Khurana, M.D., Maya Family Medical Center, Chicago, IL, Chicago District Two informed consent issues were uncovered and cited in a 483 in this follow-up investigation of clinical investigator, Chandra Khurana, M.D., lead...

BiMo FOIA log.
February 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...

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

Untitled letters.
February 1, 2003... The following untitled letters were issued by the Promotion and Advertising Staff 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...

IRB Determination letters.(Brief Article)
February 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...