Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Code List
Planned Relative Time Vital Signs
CL Item
4 hrs post-dose (3)
Actual Time Vital Signs
Item
Actual Time Vital Signs
time
C2826762 (UMLS CUI [1])
Blood Pressure systolic
Item
Blood Pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure diastolic
Item
Blood Pressure diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Date sample taken
Item
Date sample taken Drug and Alcohol Screen
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time sample taken
Item
Time sample taken Drug and Alcohol Screen
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Code List
Benzodiazepines
Item
Cannabis metabolites
integer
C0936079 (UMLS CUI [1,1])
C0870883 (UMLS CUI [1,2])
Code List
Cannabis metabolites
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Item
PCP
integer
C0031381 (UMLS CUI [1])
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
C0001948 (UMLS CUI [2])
Lab ID
Item
Lab ID
text
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date Sample taken Haematology
Item
Date Sample taken Haematology
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time sample taken Haematology
Item
Time sample taken Haematology
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Haematology
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Code List
Planned Relative Time Haematology
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Haemoglobin (Hb)
Item
Haemoglobin (Hb)
text
C0518015 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
text
C0018935 (UMLS CUI [1])
Platelet count (absolute)
Item
Platelet count (absolute)
text
C0032181 (UMLS CUI [1])
White blood cell count (WBC) (Absolute)
Item
White blood cell count (WBC) (Absolute)
text
C0023508 (UMLS CUI [1])
Neutrophil count (absolute)
Item
Neutrophil count (absolute)
text
C0948762 (UMLS CUI [1])
Lymphocyte count (absolute)
Item
Lymphocyte count (absolute)
text
C3544087 (UMLS CUI [1])
Monocyte count (absolute)
Item
Monocyte count (absolute)
text
C0200637 (UMLS CUI [1])
Eosinophil count (absolute)
Item
Eosinophil count (absolute)
text
C0200638 (UMLS CUI [1])
Basophil count (absolute)
Item
Basophil count (absolute)
text
C0200641 (UMLS CUI [1])
Lab ID
Item
Lab ID
integer
C0022877 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date sample taken
Item
Date sample taken clinical chemistry
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Sample Taken
Item
Time Sample Taken Clinical Chemistry
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Code List
Planned Relative Time Clinical Chemistry
CL Item
Check-in (Result 1) (1)
CL Item
24 hours post-dose (Result 2) (2)
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Glucose (fasting)
Item
Glucose (fasting)
float
C0583513 (UMLS CUI [1])
Total Protein
Item
Total Protein
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Total bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
AST (SGOT)
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
ALT (SGPT)
Item
ALT (SGPT)
float
C0201836 (UMLS CUI [1])
Serum Creatinine
Item
Serum Creatinine
float
C0201976 (UMLS CUI [1])
BUN
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Creatine Phosphokinase (CPK)
Item
Creatine Phosphokinase (CPK)
float
C0201973 (UMLS CUI [1])
fasting status
Item
Did the subject fast for 10 hours prior to dosing?
boolean
C0015663 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
correct treatment
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
reason correct treatment not recieved
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
Bottle A (small tablet #1) (1)
CL Item
Bottle B (small tablet #2) (2)
CL Item
Bottle C (large tablet) (3)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
float
C2348070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Planned Relative Time, check one
integer
C0439564 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Code List
Planned Relative Time, check one
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Aliquot sample taken
Item
2 mL Aliquot, check if taken
boolean
C1277698 (UMLS CUI [1,1])
C1510844 (UMLS CUI [1,2])
Sample Number
Item
Sample Number
integer
C1299222 (UMLS CUI [1])