Bioresearch Monitoring Alert articles from June 2005

Bioresearch Monitoring Alert archives from June 2005

OHRP director says HHS considering guidance on CI training.(Clinical investigators)
June 1, 2005... ELLICOTT CITY, MD -- The lack of mandatory, formal training for clinical investigators is a problem of which the Department of Health and Human Services (HHS) is aware, and the department currently is considering regulations and guidance to...

HHS issues calls for proposals for 'electronic health record' system.(Electronic records)
June 1, 2005... PRINCETON, NJ -- In an attempt to move President Bush's call for a national electronic health record (EHR) system forward, the nation's top health IT coordinator called upon public and private industries to put their best people--and...

Attitudinal segmentation helps learn subjects' attitudes and needs, increases recruitment.(Subject protection)
June 1, 2005... ELLICOTT CITY, MD -- With fewer than 10% of the U.S. population involved in clinical trials, attitudinal segmentation is useful to identify the highly complex motivations affecting human subject research participants' decisions to participate...

Trial delays tied to high drop-out rates; outreach boosts participation.(Recruitment)
June 1, 2005... ELLICOTT CITY, MD -- Seventy-two percent of clinical trials were delayed in 2003, a significant reason being a 73% drop-out rate for human research subjects participating in Phase I-IV clinical trials, said Roni Thaler, president and CEO,...

Sponsor-investigators should have outsider monitor studies, even a staffer.(Sponsors/investigators)
June 1, 2005... Clinical investigators who also are the sponsors of their own studies should have an outsider monitor the trial, but even a staff person--as long as that person is not the investigator himself--could also do the job, a noted GCP expert told a...

CI receives 3-item 483 for adverse events, patient enrollment.(Clinical investigators)
June 1, 2005... Lon Annest, M.D., Tacoma, WA, Bothell, WA, District Failure to submit reports of serious adverse events (SAES) to the IRB and enrolling an ineligible subject were violations that led to a three-item 483 for Lon Annest, M.D., Tacoma, WA....

MDS Pharma Services slapped with 3-item 483 concerning contamination following bioequivalence audit.(CROs)
June 1, 2005... MDS Pharma Services, St. Laurent, PQ, Canada, Irvine, CA, District MDS Pharma Services, St. Laurent, PQ, Canada, did not assure the accuracy of loratidine and descarboethoxyloratidine concentrations in study subject samples, resulting in...

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

IRB Determination Letters.
June 1, 2005... The following are Compliance Determination Letters for IRBs issued in May 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)(Bioresearch Monitoring)
June 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...