Ongoing Processes & Procedures

  • Template: Monitor Visit Summary Form
    		• A summary for single monitoring visits.
  • Template: Ongoing Monitoring Log
    		• Tracks all monitoring visits (Placed in Regulatory Binder).
  • Template: Clinical Trial Freezer Temperature Log
    		• Daily temperature log.
  • Guidance: Adverse Events, Unexpected & Serious AE Reporting
    		• Under Construction
  • Template: Adverse Events Log
    		• Individual Participant running log for all Adverse Events.
  • Guidance: Protocol Deviations & Violations
    		• Definitions, descriptions of regulations and submissions, pertinent templates and procedures involving protocol deviations and violations.
  • Template: Protocol Deviation & Violation Log
    		• A running log of all protocol deviations and violations that can be sent to the IRB.
  • Template: Protocol Violation Report
    		• A template that contains the IRB requirements for reporting a violation when one occurs.
  • Template: Violation Report Memo
    		• Appropriately formatted and to be sent to the IRB accompanying the Violation Report.
  • Template: Protocol Deviation & Violation Memo
    		• Appropriately formatted to accompany the Protocol Deviation Log at the time of continuing review.
  • Guidance: Participant Lost to Follow-Up
    		• An example of how a team might formulate their standard operating procedure for a participant being lost to follow-up.
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