Safety Assessment Test - Laboratory

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