Role Of Research Flashcards
2 types of studies
Observational
Interventional
What sets out principles requirements and standards for clinical and non clinical research in the UK
Research governance framework
What is the international ethical and scientific quality standard for designing, recording, and reporting trials involving human subjects
Good clinical practice GCP
Investigational medicinal product
Unlicensed new drug, existing drug tested outside of its license, or existing drugs tested against each other
Adverse event
Any unintended response in a subject administered an IMP regardless of whether caused by IMP or not
Adverse reaction
Unintended response to IMP caused by IMP
Serious adverse event
Medical occurrence causing death, life threatening, requires inpatient hospitalisation/ prolongs existing hospitalisation, causes significant disability, causes a congenital abnormality/birth defect, not necessarily related to IMP
Sudden adverse reaction
Serious adverse event caused by IMP
Sudden unexpected serious adverse reaction
Unexpected sudden adverse reaction not consistent with current info on IMP
What does phase 1 of a clinical trial determine
Safety and target dose
What does phase 2 of a clinical trial determine
Evidence of activity
What does phase 3 of a clinical trial determine
Improvement of clinical outcome
What does phase 4 of a clinical trial determine
Safety issues in standard clinical care with large pt number
What defines maximum tolerated dose
Rate of observed dose limiting toxicities
Where can pt samples from trials be stored for future research
Biobanks
