Bioresearch Monitoring Alert articles from October 2004

Bioresearch Monitoring Alert archives from October 2004

FDA, OHRP collaborating on guidance for non-English speaking subjects; BiMo program eyeing more overseas inspections.(Food and Drug Administration, Office for Human Research Protections, independent research board)
October 1, 2004... MONTREAL -- FDA is collaborating with the Office for Human Research Protections (OHRP) on a guidance related to obtaining and documenting informed consent from subjects who do not speak English, along with a pending IRB registration rule and...

FDA reports spike of trials submitted to Clinicaltrials.gov.(Trial disclosure, Food and Drug Administration)
October 1, 2004... A month after the New York state attorney general sued Pfizer for allegedly failing to disclose adverse results of pediatric studies with anti-depressants, the joint FDA-National Library of Medicine database called "Clinicaltrials.gov" received...

FDA-OHRP Workshop on central review recommended.(Central IRB Review, National Institutes of Health)(Office for Human Research Protections, Food and Drug Administration)
October 1, 2004... ALEXANDRIA, VA -- The Secretary's Advisory Committee on Human Research Protections (SACHRP) agreed to recommend that FDA, NIH and OHRP consider holding a coordinated workshop on human subject research with regard to the use of central review...

GEREQ provides quality assurance to Canadian sites.(International)(gestion recherche clinique/qualite, safe operating practice)
October 1, 2004... MONTREAL -- Many Canadian clinical trial sites are lacking SOPs, despite their recognized importance for ensuring the quality of research, so the Canadian government has stepped in by providing funding for a program that gets standardized...

SACHRP okays establishing subcommittee to review Subpart A.(independent research board )(Secretary's Advisory Committee on Human Research Protections)(Brief Article)
October 1, 2004... ALEXANDRIA, VA -- At a meeting here October 4-5, the Secretary's Advisory Committee on Human Research Protections (SACHRP) approved the establishment of a subcommittee to analyze Subpart A in order to improve how it functions. Members of the...

FDA inspector notes fraud in animal studies.(GLPs/fraud)
October 1, 2004... MONTREAL -- An inspector from FDA's New York District said on Sept. 24 that study monitors not only need to be wary of fraud and misconduct in clinical trials, but in animal studies as well. Investigator Thomas P. Hansen told the SoCRA...

Records-related violations drop in Canada, but QS citations increase.(Inspections)(quality systems)
October 1, 2004... MONTREAL -- Canadian trial sites inspected by the Health Products and Food Branch (HPFB) of Health Canada in 2003-04 realized a decline in the number of citations for records-related violations, but an increase in "quality systems-related"...

Cheatham hit with 483 for improper informed consent documents, warning letter for unapproved device.(Clinical investigators, John Cheatham)
October 1, 2004... John Cheatham, M.D., Columbus Children's Hospital, Columbus, OH, Cincinnati District Incomplete and inaccurate informed consent documents and other violations earned a three-item 483 for John Cheatham, M.D., Columbus Children's Hospital,...

IRB slapped with 3-item 483 for failure to follow SOPs, deficient continuing review practices.(independent research board, safe operating practice )
October 1, 2004... IntegReview Ethical Review Board, Austin, TX, Dallas District An initial inspection of IntegReview Ethical Review Board, Austin, TX, netted the IRB a three-item 483 for failure to follow established SOPs, deficient continuing review...

Warning letters.(Food and Drug Administration issues warning letters to clinical investigators)
October 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of August 30 and September 4-30, 2004. Each letter is $7 plus retrieval. Please order by RECORD- RETRIEVE...

IRB determination letters.
October 1, 2004... The following are Compliance Determination Letters for IRBs issued in September 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.
October 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...