Bioresearch Monitoring Alert articles from May 2004

Bioresearch Monitoring Alert archives from May 2004

NIH may look more closely at non-competing grant recipients: expect increased scrutiny, former HHS inspector general warns.(Fraud and abuse)(National Institutes of Health)
May 1, 2004... BALTIMORE -- Recipients of non-competing National Institutes of Health research grants should be forewamed that agency inspectors are on the lookout for to possible violations of fraud and abuse laws, including conflict-of-interest standards....

FDA 'critical path' plan may consider failed trial reviews.(Clinical trials)
May 1, 2004... FDA may do its own retrospective review of clinical and animal studies that failed or were discontinued in order to avoid exposing subjects to harm in future studies, as part of the agency's "critical path" initiative, a top Center for Drugs...

Certifying conflict docs could pose legal problems for trial sites.(Ethics)
May 1, 2004... BALTIMORE -- Many research institutions are placing themselves in a precarious legal situation by certifying financial disclosure, conflict-of-interest and other clinical trial documents without fully investigating the information they contain,...

Post-approval GCP/HIPAA adherence still needed, less oversight.(Phase IV studies)(Good Clinical Practices, Health Insurance Portability and Accountability Act)
May 1, 2004... ORLANDO, FL -- Although Phase IV clinical studies are different from earlier studies--in that Phases I-III concern obtaining regulatory approval while some Phase IV studies border on marketing--CROs and sponsors should still adhere to Good...

Triage seen key for reporting; regs sketchy.(Adverse event reporting)(clinical trials)
May 1, 2004... BALTIMORE -- Research institutions need to take advantage of the general nature and flexibility of adverse event reporting deadlines and definitions under federal law, speakers told a workshop here April 21 at the Fourth National Medical...

Consent forms should be revised to better reflect diversity.(Informed consent)
May 1, 2004... CLEARWATER, FL -- IRBs and sponsors must become more cognizant of cultural differences among prospective subjects when devising consent forms, and may want to examine some procedures used in social science research. Addressing the...

CI implants investigational devices without IRB approval.(Clinical investigators)
May 1, 2004... Frank Criado, M.D., Union Memorial Hospital, Baltimore, MD, Baltimore District Serious deviations including failure to report serious adverse events to the IRB and implanting an investigational device without IRB approval landed Frank...

Missing trial records plague device study.
May 1, 2004... Randall Ehrlich, M.D., Bronx, NY, New York District FDA investigators discovered there were no case report forms, medical records or informed consent documents available for review for a device study conducted by CI Randall Ehrlich, M.D.,...

CI failed to follow investigational plan.(Counterintelligence)
May 1, 2004... Joseph David, M.D., Charlottesville Medical Research, Charlottesville, VA, Baltimore District Principal investigator Joseph David, M.D., received a one-item 483 for failing to conduct a drag trial according to the investigational plan. The...

Warning letters.
May 1, 2004... The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued the weeks of April 5, 12, 19 and 26, 2004. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number...

IRB determination letters.
May 1, 2004... The following are Compliance Determination Letters for IRBs issued in March and 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...

BiMo FOIA log.(Freedom of Information Act)
May 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...