Bioresearch Monitoring Alert articles from July 2005

Bioresearch Monitoring Alert archives from July 2005

PhRMA sees uploading all trial data since 2002 by September, but value of public reaistries debated.(Registries)
July 1, 2005... PHILADELPHIA -- The Pharmaceutical Research & Manufacturers of America (PhRMA) expects to meet its goal of having all trial data compiled by its member companies for studies initiated after Oct. 1, 2002, to be uploaded to the association's...

Attorney advises omitting 'costs' in trial contracts to lessen chance of non-payment.(Trial agreements)
July 1, 2005... ALEXANDRIA, VA -- When an institution negotiates an agreement with a drug company to do a clinical trial, it is critical that the contract omit any language referring to "costs" of procedures, because this may be construed as fraud, which can...

Pharma firms need to get hip to HIPAA, particularly concerning CROs and PBMs, attorney says.(HIPAA)
July 1, 2005... NEW YORK -- Ignorance of Health Insurance Portability and Accountability Act (HIPAA) privacy rules can land pharmaceutical manufacturers in hot water, according to the former chief counsel of one of the nation's biggest health insurers. ...

While quantity of warning letters drop, severity rises, especially with adverse event reporting.(Compliance/enforcement)
July 1, 2005... NEW YORK -- While FDA is sending out fewer warning letters, the ones that make it to the mailbox are all the more weighty, especially regarding adverse event (AE) reporting issues, according to a pharmaceutical fraud and abuse expert. ...

Lepay says warning letter for e-records violations not sign of more Part 11 enforcement.(Electronic records)
July 1, 2005... WASHINGTON -- A recent warning letter to a Great Neck, NY, clinical investigator, which cited FDA's electronic records regulations (21 CFR Part 11) regarding the site's electronic medical record (EMR) system, is not a sign of new policy...

Aman cited for research changes unapproved by IRB, failure to prepare accurate case histories.(Clinical investigators)
July 1, 2005... Michael Aman, Ph.D., Ohio State University, Columbus, OH, Cincinnati District Not submitting research changes to the IRB for approval and failure to prepare or maintain accurate case histories landed a three-item 483 in an initial inspection...

Londborg slapped with 1-item 483 for improper interviewing of subjects and parents.(Clinical investigators)
July 1, 2005... Peter Londborg, M.D., Seattle Clinical Research Center, Seattle, Bothell, WA, District An initial inspection found that Peter Londborg, M.D., Seattle Clinical Research Center, Seattle, WA, used the Children's Depression Rating Scale...

CI receives 1-item 483 for SAEs, subject screening, drug records.(Clinical investigators)
July 1, 2005... Christopher Marrero, M.D., New Orleans, New Orleans District Office Christopher Marrero, M.D., New Orleans, was cited in a one-item 483 for failing to conduct his investigation in accordance with the signed investigative plan. New Orleans...

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

BiMo FOIA log.(Bioresearch Monitoring)(Freedom of Information Act)
July 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...