Bioresearch Monitoring Alert articles from January 2004

Bioresearch Monitoring Alert archives from January 2004

CIs should be first to report adverse events, not IRBs, SACHRP advises; FDA won't bend on DMC role.(Adverse event reporting)(clinical investigator)(Institutional Review Boards)(Secretary's Advisory Committee on Human Research Protections)(United States. Food and Drug Administration)
January 1, 2004... The consensus on adverse event (AE) reporting from the Secretary's Advisory Committee on Human Research Protections (SACHRP), which met in Washington, Dec. 11-12, was that the brunt of the initial reporting responsibility should come from the...

City of hope develops means to handle AE deluge.
January 1, 2004... Because of the regulatory network, "IRBs are being rained down by thousands of AEs for subjects that they have no responsibility for," reported John Zaia, M.D., chair, IRB, City of Hope National Medical Center, Duarte, CA, to the SACHRP...

New policy may negate need for reviewing oral histories; OHRP promises guidance.(IRBs)(Office for Human Research Protections)(United States. Department of Health and Human Services. Institutional Review Board)
January 1, 2004... The Office for Human Research Protections (OHRP) may develop a policy guidance document to explain a September letter, in which the agency said oral histories are not considered "research" under HHS rules and thus not subject to IRB initial...

VA medical center finds AAHRPP accreditation more useful than NCQA.(Accreditation)(Accreditation of Human Research Protection Programs)(National Committee on Quality Assurance)
January 1, 2004... Accreditation measures the translation of ethical principles into real protection, says Franklin Zieve, M.D., associate chief of staff for Research at the Hunter Holmes McGuire VA Medical Center, Richmond, VA, whose institution was the first...

Making the most of IRB meetings: tips for avoiding common pitfalls.(IRBs)(United States. Department of Health and Human Services. Institutional Review Board)
January 1, 2004... IRB meetings will run more smoothly if the responsibility for conducting them is shared among IRB members, said Melissa Lewis, president of Upside Down Speaking, who addressed ARENA attendees Dec. 5 in Washington. She shared various "traps"...

Firm prevents FDA from reviewing records, citing "client confidentiality".(GLPs)(United States. Food and Drug Administration)(good laboratory practices)(Molecular Diagnostic Services)
January 1, 2004... Molecular Diagnostic Services, San Diego, CA, Los Angeles District FDA's Allen Hall of the Los Angeles District showed up at the doors of Molecular Diagnostic Services to conduct a GLP inspection. It was to be the firm's initial...

IRB kept sloppy records, failed to review critical information.(IRBs)(Huntsville Hospital)(Institutional Review Board )
January 1, 2004... Huntsville Hospital IRC, Huntsville, AL, New Orleans District Serious objectionable conditions, including failure to ensure that principal investigators (PIs) submit serious adverse event (SAEs) reports, failure to maintain adequate...

Pacific University IRB kept little records, had no written procedures for IRB activities.(IRBs)(Institutional Review Board )
January 1, 2004... Pacific University Institutional Review Board, Forest Grove, OR, Seattle District A team from FDA's Seattle District handed Pacific University's IRB a 483 for serious record-keeping deficiencies, including failure to approve research at...

CI fails to obtain written informed consent prior to treatment.(Clinical investigators)
January 1, 2004... William Stevenson, M.D., Brigham and Women's Hospital, Boston, MA, New England District Failure to obtain informed consent and failure to conduct the study in accordance with the investigational plan were among deficiencies that landed...

CI gets squeaky-clean report from FDA.(Clinical investigators)(Food and Drug Administration)
January 1, 2004... Daniel Zimbroff, M.D., Upland, CA, Los Angeles District Investigator Armando Chavez of FDA's Los Angeles District had little to report for clinical investigator Daniel Zimbroff, M.D., following this high-priority, pre-approval,...

Warning letters.
January 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of Dec. 15, 22 and 29, 2003, and Jan. 5, 2004. Each letter is $7 plus retrieval. Please order by...

CBER Nidpoe letter.(Notice of Initiation of Disqualification Proceeding and Opportunity to Explain)
January 1, 2004... The following is a Notice of Initiation of Disqualification Proceeding and Opportunity to Explain (NIDPOE) letter. A NIDPOE letter informs the CI that FDA is initiating an administrative proceeding to determine whether the CI should be...

BiMo FOIA log.(Freedom of Information Act)
January 1, 2004... 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...