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