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Questions

0
New to Canada, trained as a physician. Where does clinical research start for me?
New to the country0 answers
City HallOct 15, 2026
0
What do hiring managers want to see from an internationally trained physician applying for a CRA or CRC role?
Internationally trained physicians0 answers
City HallOct 15, 2026
0
Six years as a CRC. What does the first year as a CRA actually feel like?
Changing functions0 answers
City HallOct 15, 2026
0
Moving to Raleigh for a CRC role. How do I find the research people outside work?
New in town0 answers
City HallOct 15, 2026
0
A coordinator just resigned mid-study. What are the first three things you do?
Site operations1 answer
City HallOct 14, 2026
0
When must a trial be registered and results posted on ClinicalTrials.gov?
Trial conduct and operationsAnswered
City HallOct 14, 2026
0
How do you prepare a site for an inspection without panic?
Trial conduct and operations1 answer
City HallOct 14, 2026
0
Where does EMA explain GCP inspections and compliance?
Regulations and guidanceAnswered
City HallOct 14, 2026
0
What do you do in a city on a Tuesday night when the visit ends at five?
Travel1 answer
City HallOct 14, 2026
0
Where is the UK's own GCP guidance for a UK site?
Regulations and guidanceAnswered
City HallOct 14, 2026
0
Where do EU trial applications go now, and what is CTIS?
Regulations and guidanceAnswered
City HallOct 14, 2026
0
What is the difference between a protocol deviation and a violation at your site?
Regulations and guidance1 answer
City HallOct 14, 2026
0
Where does FDA say what counts as real-world evidence for a drug?
Data and systemsAnswered
City HallOct 14, 2026
0
What should I ask in a CRA interview that most people do not?
Careers1 answer
City HallOct 14, 2026
0
Where is the FDA guidance on home visits and remote trial activities?
Trial conduct and operationsAnswered
City HallOct 14, 2026
0
A site asked why they need to fill in financial disclosure forms. Where is that from?
Regulations and guidanceAnswered
City HallOct 14, 2026
0
What do you say to a patient who asks 'would you do this trial?'
Site operations1 answer
City HallOct 14, 2026
0
Where are the IND safety reporting rules, with the timelines?
SafetyAnswered
City HallOct 14, 2026
0
How do you keep a study team honest about enrollment forecasts?
Trial conduct and operations1 answer
City HallOct 14, 2026
0
Where is FDA's current informed consent guidance for a consent process question?
Site operationsAnswered
City HallOct 14, 2026
0
My PI asked what FDA actually expects of her. Which document do I send?
Site operationsAnswered
City HallOct 13, 2026
0
What is the one thing new CRAs get wrong at their first visits?
Monitoring1 answer
City HallOct 13, 2026
0
Which FDA guidance should I quote when a site asks why I am not doing 100 percent SDV?
MonitoringAnswered
City HallOct 13, 2026
0
Where is E8(R1), the one on how studies should be designed and run?
Regulations and guidanceAnswered
City HallOct 13, 2026
0
How do you talk to a site about a late SAE report without it sounding like blame?
Safety1 answer
City HallOct 13, 2026
0
I am moving from drug to device trials. Where are the IDE rules?
Regulations and guidanceAnswered
City HallOct 13, 2026
0
The EDC queries are piling up and the coordinator has stopped answering. What now?
Data and systems1 answer
City HallOct 13, 2026
0
A sponsor says 'that is in 312'. Where do I read the IND rules myself?
Regulations and guidanceAnswered
City HallOct 13, 2026
0
Where is the full list of ICH E guidelines when someone says 'check E9'?
Regulations and guidanceAnswered
City HallOct 13, 2026
0
How do you run a site initiation visit that people remember?
Trial conduct and operations1 answer
City HallOct 13, 2026
0
Is it worth moving from a site to a CRO for the money?
Careers2 answers
City HallOct 13, 2026
0
CRC to CRA. What actually gets you the interview?
Careers1 answer
City HallOct 13, 2026
0
How do you eat well on the road when you are alone every night?
Travel1 answer
City HallOct 13, 2026
0
What is your rule for packing for a two-day site visit?
Travel1 answer
City HallOct 13, 2026
0
First week as a CRC. What should I do before anyone tells me to?
Site operations1 answer
City HallOct 13, 2026
0
What do you do when a site is always 'too busy' for a visit?
Monitoring1 answer
City HallOct 13, 2026
0
A PI signs everything but never reads it. How do you fix that without a fight?
Site operations1 answer
City HallOct 13, 2026
0
How do you handle a stubborn CRA who treats every visit like an audit?
Monitoring1 answer
City HallOct 13, 2026
0
As a CRA, how do you support an overworked CRC without taking over their job?
Monitoring1 answer
City HallOct 13, 2026