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Questions for the Site Quarter

Site operations, Trial conduct and operations, Safety. Show all questions

• A coordinator just resigned mid-study. What are the first three things you do?
  Site operations1 answer
  City HallOct 14, 2026
• When must a trial be registered and results posted on ClinicalTrials.gov?
  Trial conduct and operationsAnswered
  City HallOct 14, 2026
• How do you prepare a site for an inspection without panic?
  Trial conduct and operations1 answer
  City HallOct 14, 2026
• Where is the FDA guidance on home visits and remote trial activities?
  Trial conduct and operationsAnswered
  City HallOct 14, 2026
• What do you say to a patient who asks 'would you do this trial?'
  Site operations1 answer
  City HallOct 14, 2026
• Where are the IND safety reporting rules, with the timelines?
  SafetyAnswered
  City HallOct 14, 2026
• How do you keep a study team honest about enrollment forecasts?
  Trial conduct and operations1 answer
  City HallOct 14, 2026
• Where is FDA's current informed consent guidance for a consent process question?
  Site operationsAnswered
  City HallOct 14, 2026
• My PI asked what FDA actually expects of her. Which document do I send?
  Site operationsAnswered
  City HallOct 13, 2026
• How do you talk to a site about a late SAE report without it sounding like blame?
  Safety1 answer
  City HallOct 13, 2026
• How do you run a site initiation visit that people remember?
  Trial conduct and operations1 answer
  City HallOct 13, 2026
• First week as a CRC. What should I do before anyone tells me to?
  Site operations1 answer
  City HallOct 13, 2026
• A PI signs everything but never reads it. How do you fix that without a fight?
  Site operations1 answer
  City HallOct 13, 2026