from Safety assessment in Clinical
Trials and Beyond by Yuliya Yasinskaya, MD (Nov 13, 2012)
http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM337224.pdf
Safety Assessment/Monitoring;
1) Vital Signs (Blood pressure, pulse rate, body temperature)
2) Laboratory evaluations
- CBC - complete blood count (Hematology)
- LFTs - Liver Function tests (Biochemistry)
- CPK - Creatinine tests (Biochemistry)
- Renal Funtion Tests- BUN (Blood Urine Nitrogen) (Biochemistry)
- Pancreatic enzymes
3) Special safety assessment, for instance;
- Visual, hearing
- Neurological exam - neuron responses
- ECG - electrical and muscular functions of the heart
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