Ask the city

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 operations1 answer
  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 does EMA explain GCP inspections and compliance?
  Regulations and guidance1 answer
  City HallOct 14, 2026
• What do you do in a city on a Tuesday night when the visit ends at five?
  Travel1 answer
  City HallOct 14, 2026
• Where is the UK's own GCP guidance for a UK site?
  Regulations and guidance1 answer
  City HallOct 14, 2026
• Where do EU trial applications go now, and what is CTIS?
  Regulations and guidance1 answer
  City HallOct 14, 2026
• What is the difference between a protocol deviation and a violation at your site?
  Regulations and guidance1 answer
  City HallOct 14, 2026
• Where does FDA say what counts as real-world evidence for a drug?
  Data and systems1 answer
  City HallOct 14, 2026
• What should I ask in a CRA interview that most people do not?
  Careers1 answer
  City HallOct 14, 2026
• Where is the FDA guidance on home visits and remote trial activities?
  Trial conduct and operations1 answer
  City HallOct 14, 2026
• A site asked why they need to fill in financial disclosure forms. Where is that from?
  Regulations and guidance1 answer
  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?
  Safety1 answer
  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 operations1 answer
  City HallOct 14, 2026
• My PI asked what FDA actually expects of her. Which document do I send?
  Site operations1 answer
  City HallOct 13, 2026
• What is the one thing new CRAs get wrong at their first visits?
  Monitoring1 answer
  City HallOct 13, 2026
• Which FDA guidance should I quote when a site asks why I am not doing 100 percent SDV?
  Monitoring1 answer
  City HallOct 13, 2026
• Where is E8(R1), the one on how studies should be designed and run?
  Regulations and guidance1 answer
  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
• I am moving from drug to device trials. Where are the IDE rules?
  Regulations and guidance1 answer
  City HallOct 13, 2026
• The EDC queries are piling up and the coordinator has stopped answering. What now?
  Data and systems1 answer
  City HallOct 13, 2026
• A sponsor says 'that is in 312'. Where do I read the IND rules myself?
  Regulations and guidance1 answer
  City HallOct 13, 2026
• Where is the full list of ICH E guidelines when someone says 'check E9'?
  Regulations and guidance1 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
• Is it worth moving from a site to a CRO for the money?
  Careers1 answer
  City HallOct 13, 2026
• CRC to CRA. What actually gets you the interview?
  Careers1 answer
  City HallOct 13, 2026
• How do you eat well on the road when you are alone every night?
  Travel1 answer
  City HallOct 13, 2026
• What is your rule for packing for a two-day site visit?
  Travel1 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
• What do you do when a site is always 'too busy' for a visit?
  Monitoring1 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
• How do you handle a stubborn CRA who treats every visit like an audit?
  Monitoring1 answer
  City HallOct 13, 2026
• As a CRA, how do you support an overworked CRC without taking over their job?
  Monitoring1 answer
  City HallOct 13, 2026