The following ten areas are routinely examined during our routine on-site review and investigator self-assessments.

           Regulatory documentation
           IRB documentation
           Subject recruitment
           Informed consent process
           Subject selection
           Adverse event reporting
           Drug/device dispensing/accountability
           Source documentation/case report form (CRF)
           Record keeping
           Allocation of responsibilities

Between May 2004 and December 2004, Monitoring and Oversight conducted routine onsite reviews.  Each study site was assessed for its compliance with regulations and institutional policies.  Monitoring and Oversight provided corrective actions when violations were identified. 

Most problematic areas