Bioresearch Monitoring Alert articles from May 2005

Bioresearch Monitoring Alert archives from May 2005

Tufts study finds steep decline in U.S.-based Cls; capacity to conduct clinical studies threatened.(Clinical investigators)
May 1, 2005... The total number of FDA-regulated U.S. clinical investigators plunged 11% from 2001 to 2003, while the proportion of female to male PIs is "steadily declining" and is significantly below the ratio of female-to-male board certified physicians, a...

JCAHO, other groups to distribute educational brochure to clinical trial participants.(Human subject protection)
May 1, 2005... The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and two other prestigious organizations will devise a new brochure to educate potential subjects who enter clinical trials, officials announced May 12 at an audiobriefing...

OH RP new cases drop, but on-site visits increasing; restricted assurances level since '02.(IRB compliance)(Office for Human Research Protections)(Institutional Review Board)
May 1, 2005... IRB non-compliance being investigated by Office for Human Research Protections (OHRP) dropped in 2004 to its lowest level since 1990, but the number of on-site visits is the highest since 1998, the director of OHRP compliance activities told a...

Device industry trade group says CDRH report unfairly disparages device industry.(Post-marketing studies)
May 1, 2005... The March 18 CDRH report "Condition of Approval Studies as a Postmarket Tool for PMA Approved Cohort 1998-2000" wrongly maligns device manufacturers for being out of compliance in their conduct of Condition of Approval (CoA) studies, the...

SACHRP debates how to best educate PIs; carrot, stick approaches considered.(Secretary's Advisory Committee on Human Research Protections)(principal investigators)
May 1, 2005... ALEXANDRIA, VA -- At the Secretary's Advisory Committee on Human Research Protections (SACHRP) meeting here April 19, many speakers and SACHRP members expressed concern about the lack of consistent training for PIs, potential solutions and the...

IRB IO should not be high-level official.(Institutional Review Board)(institutional official)
May 1, 2005... ALEXANDRIA, VA -- The necessary qualifications of an IRB institutional official (IO) are not spelled out in OHRP regulations, but the ideal IO should not be a high-level official, such as, a university president, advised Richard Blanco,...

CI nets 6-item 483 for failure to report AEs; informed consent, record maintenance also noted.(Clinical investigators)
May 1, 2005... Hyun Kim, M.D., Johns Hopkins Hospital, Baltimore, Baltimore District Hyun Kim, M.D., John Hopkins Hospital, Baltimore, was cited in a comprehensive Center for Devices inspection for not submitting two unanticipated adverse events (AEs) to...

MicroTest Labs issued 3-item 483, Part 11 flaws noted.(CROs/labs)
May 1, 2005... MicroTest Laboratories, Agawath, MA, Stoneham, MA, District A three-item 483 was given to MicroTest Laboratories, Agawath, MA, for incomplete records for growth promotion test results and for bacteriostatis testing not meeting USP...

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

IRB determination letters.
May 1, 2005... The following are Compliance Determination Letters for IRBs issued in April 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...

BiM o FOIA log.
May 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...