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  • A written report from the monitor detailing all activities and findings of a monitoring visit.

  • A written report from the CRA detailing the monitoring activities performed at site and the follow-up requirements to be performed by the site prior to the next monitoring visit. 

  • A written report from the monitor detailing all activities, findings and source data verification performed at a monitoring visit.

  • A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.