Bioresearch Monitoring Alert articles from September 2005

Bioresearch Monitoring Alert archives from September 2005

More 483 violations for international clinical investigators in 2004 highlight need for training and added scrutiny.(Clinical investigators)
September 1, 2005... WASHINGTON -- More domestic companies are using international clinical investigators outside of Canada and Europe, which led to increased violations in protocol, records, informed consent and adverse event., in 2004 as compared to 2003 (See...

Getting consent of family, quizzing subjects suggested.(Informed consent)
September 1, 2005... By BioResearch Monitoring Alert Staff Sponsors, IRBs and clinical researchers should consider obtaining the consent of family members even if a subject can read and understand the consent form, a specialist in the field told a Sept. 12...

Consider a variety of late-phase training options for PIs and SCs, including webcasts.(Training)
September 1, 2005... WASHINGTON -- The era of clinical trial litigation is here, so it is important to try different ways to educate principal investigators (PIs) and study coordinators (SCs) during late-phase clinical trials, including webcasts, online seminars...

The regulation of clinical trials under state laws.(Guest Column)
September 1, 2005... The primary regulatory framework for conducting clinical trials in the U. S. is set forth under Title 21 of the Code of Federal Regulations, which address the protection of human subjects, IRBs and financial relationships, as well as other...

CAPA programs for clinical research not required by FDA rules, but essential to correct problems.(Corrective/preventive action)
September 1, 2005... WASHINGTON -- Although corrective and preventive action (CAPA) programs for clinical research are not required by agency regulations, FDA refers to them in guidance and does expect you to correct problems that occur in your research, an...

Canby at Texas Cardiac receives 1-item 483 for case history flaws.(Clinical investigators)(Brief Article)
September 1, 2005... Robert Canby, M.D. Texas Cardiac Arrhythmia Research, Austin, TX, Dallas District Case history reports were not prepared and maintained properly by Robert Canby, M.D., at Texas Cardiac Arrhythmia Research, Austin, TX, netting the doctor a...

Chan cited in two 483 violations for faulty informed consent procedures.
September 1, 2005... Juliana Chan, M.D., Shatin, New Territories, Hong Kong, CBER Juliana Chan, M.D., Shatin, New Territories, Hong Kong, failed to obtain written informed consent for two patients, and three other patients signed an informed consent document...

Sponsor-investigator cited for failure to submit IND in 8-item 483.
September 1, 2005... Ritchie Shoemaker, MD., Pocomoke City, MD, Baltimore District Failure to submit an IND to FDA before conducting a clinical investigation with an investigational new drug netted an eight-item 483 for Ritchie Shoemaker, M.D., Pocomoke City,...

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

IRB Determination Letters.
September 1, 2005... The following are Compliance Determination Letters for IRBs issued in August 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.(Freedom of Information Act)
September 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...