Bioresearch Monitoring Alert articles from August 2005

Bioresearch Monitoring Alert archives from August 2005

OHRP, FDA need to produce joint, consolidated guidance on expedited review: HHS panel.(Expedited review)
August 1, 2005... ALEXANDRIA, VA -- FDA and the Office for Human Research Protections (OHRP) should issue joint, consolidated guidance on expedited review, and archived or obsolete guidance should be retired and removed from the searchable sections of the...

500 institutions seen accredited voluntarily by 2010; AAHRPP head says IRBs more compliant.(IRBs/accreditation)(Accreditation of Human Research Protection Programs)
August 1, 2005... By BioResearch Monitoring Staff About 500 institutions comprising more than 1,500 sites could be accredited voluntarily within the next five years, according to the executive director of the Assn. for the Accreditation of Human Research...

CDER gets 200 investigator misconduct complaints in 2004, but few audited due to lack of staff, FDAer says.(Misconduct/inspections)(The Center for Drugs)
August 1, 2005... WASHINGTON -- The Center for Drugs received 200 complaints alleging clinical trial misconduct in fiscal 2004 (which ended Sept. 30), but due to limited resources, only a limited number of the sites in question were inspected, according to an...

FDAer urges submission of applications with SDTM datasets; possibly mandatory in distant future.(United States. Food and Drug Administration)(Study Data Tabulation Model)
August 1, 2005... WASHINGTON -- Since the Center for Drugs began to accept Study Data Tabulation Model (SDTM) datasets on July 21, 2004, the learning curve for each new application has been greatly reduced and reviewers are able to find data much faster, which...

Subcommittee says continuing review must be simplified and permissive, not proscriptive.(Continuing review)
August 1, 2005... ALEXANDRIA, VA -- In an environment where concerns about litigation drive institutional behavior, the absence of clear, consolidated continuing review guidance results in unrealistic demands on IRBs and investigators without substantively...

DeSilva escapes 483, but SAEs and numerous documentation errors noted in audit.(Clinical investigators)(serious adverse events)
August 1, 2005... Himasiri DeSilva, M.D., Santa Ana, CA, Irvine, CA, District No 483 resulted in an inspection of clinical investigator Himasiri DeSilva, M.D., because DeSilva was not the principal investigator when most violations occurred, which included...

Perryman cited for case history flaws and failing to follow entire investigational plan.(clinical investigators)
August 1, 2005... Teri Perryman, M.D., Seguin, TX, Dallas District Clinical investigator Teri Perryman, M.D., Seguin, TX, received a 483 for failure to prepare and maintain accurate case histories, and for not conducting an investigation according to the...

Protocol deviations noted for Riff, no 483 issued.(clinical investigators)
August 1, 2005... Dennis Riff, M.D., Anaheim, CA, Los Angeles District Record keeping and minor protocol violations were noted in a comprehensive GCP audit of investigator Dennis Riff, M.D., Anaheim, CA, but no 483 was issued because the sponsor had already...

Warning letters.
August 1, 2005... The following are recent FDA warning SERVICE@FDAINFO.COM. Clark Bishop, M.D., Utah Valley Institute of Cystic Fibrosis, Utah letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in August 2005. Each letter is...

IRB Determination Letters.
August 1, 2005... The following are Compliance Determination Letters for IRBs issued in July 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.(Brief Article)
August 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...