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Sponsors need to assure GCP compliance to reduce legal liability.(Sponsor/monitors)
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 staff.
This was the message of several speakers at CBI's meeting in Philadelphia Dec. 4-5. They suggested that a number of areas that are not traditionally the responsibility of the sponsor now are falling under their purview.
The most damaging issue is misconduct or outright fraud in a clinical trial, and how regulators will view a sponsor's complicity in it. Overall, a wider net is being cast and sponsors are liable to be caught in it. "It's a slippery …
