1:30 Harmonizing Different Official Consent Frameworks for CSF & Plasma Collection to Accelerate Ethical & Compliant Clinical Trials
Time: 1:30 pm
day: Conference Day 2
Details:
- IRB and EC quantitative, qualitative and ethical requirements to ensure patient safety and well-being
- A walk-through best practice for getting informed patients consent for clinical trials considering populations with cognitive impairment
- Overview of FDA, EMA, and MHRA roles in shaping consent standards for CSF and plasma collection
