Bioresearch Monitoring Alert articles from December 2005

Bioresearch Monitoring Alert archives from December 2005

Liability, federal rules dissuade use of alternative and central reviews; OHRP eyes national conference.(IRBs)
December 1, 2005... WASHINGTON -- IRBs are not using alternative review methods in great number--such as central IRBs--because of liability concerns and recommendations by attorneys at their institutions not to pass off responsibility to a central body if...

Trial design, exclusion criteria, vulnerable groups seen causing trial suits.(Litigation)
December 1, 2005... PHILADELPHIA -- Emerging theories aside, there are three primary areas currently fueling clinical trials litigation--design of clinical trials, exclusionary criteria used to recruit subjects and the handling of vulnerable populations, defense...

Patient privacy, informed consent becoming key issues in clinical trials litigation.(Consent/privacy)
December 1, 2005... PHILADELPHIA -- A central note sounded at CBI's meeting here Dec. 4-5 was patient privacy, the regulatory focus on it and the importance of conducting a sound informed consent process. "The government is definitely looking to enforce...

Sponsors need to assure GCP compliance to reduce legal liability.(Sponsor/monitors)
December 1, 2005... PHILADELPHIA -- Given that clinical trials are under siege in the courts and in the public eye, trial sponsors would be wise to assure that GCPs and the importance of data integrity are fully embraced by IRBs, investigators and clinical...

FDA fine-tuning its position on trials controlled by placebo.(Placebos)
December 1, 2005... PHILADELPHIA -- A clinical trial characterized as a "medical experiment" is perhaps the most inflammatory accusation being made in the courts today, and the fuel for this fire is placebo-controlled trials, attorneys told CBI Dec. 4. In...

Pre-approval audit finds investigational plan not followed, incomplete case histories.(Clinical investigators)
December 1, 2005... Daniel Cohen, M.D., Boston, Stoneham, MA, District A pre-approval data validation inspection of Daniel Cohen, M.D., Boston, MA, found the clinical investigator (CI) did not conduct his research in accordance with the investigational...

Warning letters.(Case study of Spencer Jones)
December 1, 2005... Spencer Jones, M.D., Salt Lake City, Oct. 27 (CDER) During an Aug. 11-26 inspection, FDA investigator Ginger Sykes conducted the audit to determine whether Jones' clinical site activities and procedures relating to an unnamed pediatric local...

NIDPOE letters.(Brief Article)
December 1, 2005... Between Feb. 17 and March 23, and again from March 30 to April 1, 2004, FDA investigators conducted investigations to determine Wholey's conduct as a clinical investigator regarding two unnamed investigational device studies. The...

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