Bioresearch Monitoring Alert articles from July 2003

Bioresearch Monitoring Alert archives from July 2003

'IRB shopping rule,' DMC guidance on hold, Lepay tells SOCRA.(IRBs)(data monitoring committees, David Lepay, Society of Clinical Research Associates)
July 1, 2003... PITTSBURGH -- FDA has suspended further work on an "IRB shopping rule," which would have required sponsors and clinical investigators to inform IRBs of any prior ethics board review decisions, as well as a final guidance on data monitoring...

CI violations for CBER higher than other FDA centers: Cole.(BiMo inspections)(Elaine Cole)
July 1, 2003... FDA conducted 1,100 BiMo audits in 2002. Of those inspections, 600 were clinical investigator audits, 300 were institutional review boards (IRBs), about 80 were sponsor/monitor investigations, 50 were GLP audits and about 70 were bioequivalence...

Ethical gaps in research could be solved by regional IRBs, accreditation.(Human subject protection)
July 1, 2003... A panel of experts at the BIO 2003 conference agreed that more governmental oversight coupled with regional IRBs and accreditation might help close the gap in clinical research that has resulted from technology outgrowing the research system....

VA comes under fire for not adequately protecting subjects.(Clinical trials)(Veterans Administration)
July 1, 2003... The Veterans Administration (VA) has not taken sufficient actions to strengthen its human subject protection system reported the Government Accounting Office (GAO) to the House Oversight and Investigations Committee on June 18. The GAO...

Firm cited for Master Schedule deficiencies.(GLPs)(BioReliance Corp.)
July 1, 2003... BioReliance Corp., Rockville, MD, Baltimore District A team comprised of Christine Smith and Barbara Holladay from FDA's Virginia Resident Post and Michael Skelly, Ph.D., pharmacologist, from CDER's GLP and Bioequivalence Branch, uncovered...

Quorum Review gets glowing report from FDA.(IRBs)
July 1, 2003... Quorum Review Institutional Review Board, Seattle, WA, Seattle District Seattle District inspector Teres Speer, who conducted the routine IRB inspection of Quorum Review, Seattle, WA, found only one minor clerical error during a recent...

Protocol deviations, inadequate study records land CI 483.(Clinical Investigators)(a discussion of deficiencies in maintaining adequate and accurate records)
July 1, 2003... Enrique deCastro, M.D., Northwest Women's Clinic, Portland, OR, Seattle District Numerous deficiencies in maintaining adequate and accurate records were uncovered by Seattle District's James Henry, resulting in a 483 for clinical...

Investigator gets 9-item 483 for protocol deviations, informed consent signatures.(Clinical Investigators)(a discussion of handling consent forms)
July 1, 2003... Gabor Kovaks, M.D., Laguna Beach, CA, Los Angeles District Numerous informed consent deficiencies, mishandling of adverse events, protocol deviations and incomplete subject records were cited by Los Angeles District's Diane Van Leeuwen in a...

Documentation errors prove learning lesson for initial inspection.(Clinical Investigators)
July 1, 2003... Daeyoung Roh, M.D., Nephrology Associates Medical Group, Long Beach, CA, Los Angeles District Clinical investigator Daeyoung Roh, M.D., of Nephrology Associates Medical Group, Long Beach, CA, had a bit of a rocky initial inspection and...

Warning letters.(news briefs covering FDA warning letters)
July 1, 2003... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors and CROs and testing labs issued the weeks of May 26, June 2, 16, and 23, 2003. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE...

IRB Determination Letters.
July 1, 2003... The following are Compliance Determination Letters for IRBs issued in May, June and July by the Department of Health and Human Services Office of Human Research Protections (OHRP). Each letter is $7 plus retrieval. Copies of documents related...