Town Square
Ask the city
Answers from people who do the work, with the official source attached.
Ask a question
Questions for the Sponsor Quarter
Regulations and guidance, Safety. Show all questions
- Where does EMA explain GCP inspections and compliance?Regulations and guidanceAnswered
City HallOct 14, 2026 - Where is the UK's own GCP guidance for a UK site?Regulations and guidanceAnsweredCity HallOct 14, 2026
- Where do EU trial applications go now, and what is CTIS?Regulations and guidanceAnsweredCity HallOct 14, 2026
- What is the difference between a protocol deviation and a violation at your site?Regulations and guidance1 answerCity HallOct 14, 2026
- A site asked why they need to fill in financial disclosure forms. Where is that from?Regulations and guidanceAnsweredCity HallOct 14, 2026
- Where are the IND safety reporting rules, with the timelines?SafetyAnsweredCity HallOct 14, 2026
- Where is E8(R1), the one on how studies should be designed and run?Regulations and guidanceAnsweredCity HallOct 13, 2026
- How do you talk to a site about a late SAE report without it sounding like blame?Safety1 answerCity HallOct 13, 2026
- I am moving from drug to device trials. Where are the IDE rules?Regulations and guidanceAnsweredCity HallOct 13, 2026
- A sponsor says 'that is in 312'. Where do I read the IND rules myself?Regulations and guidanceAnsweredCity HallOct 13, 2026
- Where is the full list of ICH E guidelines when someone says 'check E9'?Regulations and guidanceAnsweredCity HallOct 13, 2026