Site Monitoring

• Site Selection, Site Initiation, Routine Monitoring and Close Out Visits
• Ensure all Serious Adverse Events (SAEs) are reported according to all applicable regulations
• Evaluate and assist site with adherence to all applicable regulations and guidelines (e.g., GCP, FDA)
• Verification of proper receipt, dispensation and storage of study drug
• Monitor inclusion and exclusion criteria, primary efficacy and all other study data
• Ensure that the data are correct, complete, and supported by source documentation
• Ensure Informed Consent compliance
• Review and ensure all site regulatory documents are current
• Identify problems associated with study site(s)
• Assist sites with query resolution
• Written reports to document visits, site deficiencies and site activity