Bioresearch Monitoring Alert articles from October 2005

Bioresearch Monitoring Alert archives from October 2005

Varied IT systems and excessive paper seen complicating GCP compliance, Schwetz and Lepay tell SOCRA attendees.(Electronic records/IT)(Society of Clinical Research Associates)
October 1, 2005... LAKE BUENA VISTA, FL -- The lack of a uniform standard for clinical trial information, coupled with a proliferation of paper at trial sites, is the latest problem that FDA and the Office for Human Research Protections (OHRP) are grappling with...

State trial compliance rules vary, attorney says; insurance industry seen as hinderance in trials.(Litigation)
October 1, 2005... PHILADELPHIA -- Over the past decade, the insurance industry's role in clinical trial risk management--physical, legal and ethical--has grown. In addition, state rules and laws seem to take precedence in some litigation against sponsors...

FDAer urges trial sites to be 'gracious hosts,' even faxing map and directions.(United States. Food and Drug Administration)
October 1, 2005... LAKE BUENA VISTA, FL -- Research sites that are audited under FDA's Bioresearch Monitoring Program (BiMo) could gain brownie points with the agency by being as cooperative as possible -including giving instructions on how to get to the site....

Copernicus Group IRB rep outlines better consent-form writing.(Informed consent)
October 1, 2005... LAKE BUENA VISTA, FL -- "Informed consent is a process, not just apiece of paper," said Tammy Sayers Lesco, director of QA and regulatory compliance, Copernicus Group IRB, Cary, NC, at the SOCRA meeting here. The process involves basic and...

OHRP eyeing guidance on incident reporting, IRB review of web sites.(Adverse event reporting)
October 1, 2005... LAKE BUENA VISTA, FL -- OHRP is developing guidance on reporting incidents and unanticipated events, which would have such reports submitted to the Division of Compliance Oversight, an official told the SOCRA annual meeting here last month. ...

ChiRhoClin done in by lack of written procedures for post-marketing ADEs.(Clinical investigators)(adverse drug experiences)
October 1, 2005... ChiRhoClin, Burtonsville, MD, Baltimore District ChiRhoClin (CRC), Burtonsville, MD, was slapped with a three-item 483 and a subsequent warning letter on April 28, 2004, because the firm did not develop written procedures for the...

IDEC nets 10-item 483 for inadequate adverse event reporting.(Clinical investigators)
October 1, 2005... IDEC Pharmaceuticals, San Diego, CBER IDEC Pharmaceuticals, San Diego, received a 10-item 483 because of inadequate adverse event reporting, OOS [out-of-specification] results and a lack of data to support media hold-time specifications....

Warning letters.
October 1, 2005... Michael Gottlieb, M.D., Synergy Hematology-Oncology Associates, Los Angeles, Aug. 23 (CBER) From April 28-May 9, FDA Investigator Ronald Koller conducted an investigation to determine whether Gottlieb's clinical site activities and...

IRB determination letters.
October 1, 2005... 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.(Freedom of Information Act)(Brief Article)
October 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...