Pharmaceutical Regulatory Affairs: Open Access

Laura LaRosa

Publications

• Opinion
  Policy Change to Adequately Address Monitoring Conduct in a Risk-Based Environment
  Author(s): Laura LaRosaLaura LaRosa
  
  In the new Risk-Based (RB) environment of clinical trials, policy to prevent and address misconduct and fraud by Clinical Research Associates (CRA) is virtually nonexistent. To date, misconduct of CRAs and its potential cost to patients and sponsors has not been studied, and thus, has not been addressed. Through strong policy change, it is time for regulators to voice a firm stance that misconduct and fraud will not be tolerated by any member of the scientific community. Traditionally, onsite monitoring has been the standard for quality control with its emphasis placed on Clinical Research Site (CRS) conduct. .. Read More»
  DOI: 10.4172/2167-7689.1000178

  Abstract PDF