OHRP revises federalwide assurance *

USA - July 7 2011
The Office for Human Research Protections recently revised its Federalwide Assurance application form. 

Co-authors: Jennifer S. Geetter.

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Federal government targets TRICARE subcontractors for compliance with requirements applicable to government contractors *

USA - January 7 2011
In October 2010, the U.S. Department of Labor Office of Federal Contractor Compliance Programs (OFCCP) confirmed that a hospital participating in TRICARE is a federal contractor required to comply with Affirmative Action Plan obligations under Executive Order 11246.

Co-authors: Philip J. Castrogiovanni.

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H.R. 4796 proposes modifications to Medicare secondary payer recovery and reporting requirements *

USA - March 29 2010
H.R. 4796 proposes several changes to the Medicare Secondary Payer Act and reporting under Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007.

Co-authors: Joan Polacheck.

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FDA proposes new regulation to require sponsors to report suspected data falsification *

USA - March 9 2010
The Proposed Rule requires sponsors of clinical studies to report information indicating that any person has, or may have, engaged in falsification of data collected as part of a clinical study to the appropriate FDA center no later than 45 calendar days after the sponsor become aware of the information.

Co-authors: Jennifer S. Geetter.

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EMEA and FDA focus on clinical research safety and enforcement *

European Union, USA - August 20 2009
Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale.

Co-authors: Frank Schoneveld, Robert B. Nicholas.

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