Tuesday, December 8, 2009

Clinical Research Fraud - Prevention

Here are some tips on "How to Prevent Clinical Fraud" to Pharma Sponsors, Clinical Team Staff and CRAs and others who monitor and/or audit GCP at Investigator Clinical Study Sites...

During the pre-study evaluation, carefully scrutinize clinical sites in the following areas:
  • interest in the study
  • stability of the clinical staff onsite
  • investigator/staff interactions
  • workload
  • level of training
  • conduct GCP training at the start and throughout the study as necessary
  • emphasize company policy on fraud at the initiation visit
  • be expert on the protocol particularly with parameters that determine eligibility and primary efficacy
  • minimize the use of enrollment incentives and pressure to perform and enroll
  • don't place needless requirements or unreasonable demands on clinical sites
  • maintain frequent interaction with clinical sites through regular monitoring visits and phone calls.
Good follow-up practices and procedures and early utilization of GCP and quality control measures will undoubtedly provide rigor, expectations of clinical quality and reduce the thought and even the logistics of clinical fraud at the site.

Be involved as a monitor and sponsor. Practice follow-up. Train and insist on integrity and quality control and GCP.

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