Preliminary Study Activities

  • Guidance: Working With Monitors
    		• Describes how to successfully track monitoring visits and communicate with monitors.
  • Template: Welcome Monitor Memo
    		• Successfully outlines and communicates expectations between the coordinator and the monitor.
  • Guidance: The Informed Consent Process
    		• Describes and outlines the ongoing process of informed consent.
  • Template: Procedure Checklist
    		• Cover sheet/checklist that ensures that all visit procedures have been accomplished.
  • Guidance: Investigator And Co-Investigator CVs
    		• Describes the required contents of the Curriculum Vitae (CV) for all Study Investigators (Placed in Regulatory Binder).
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