Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C2826257 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C3174092 (UMLS CUI [2,2])
C0205435 (UMLS CUI [2,3])
Item Group
Prior Medication
C2826257 (UMLS CUI-1)
Prior Medication - Drug Name
Item
Prior Medication - Drug Name
text
C2826257 (UMLS CUI [1])
C2360065 (UMLS CUI [2])
Prior Medication - Single Dose/ Unit
Item
Prior Medication - Single Dose/ Unit
text
C2826257 (UMLS CUI [1])
C1960417 (UMLS CUI [2])
Prior Medication - Frequency of this Dose
Item
Prior Medication - Frequency of this Dose
text
C2826257 (UMLS CUI [1])
C3476109 (UMLS CUI [2])
Item
Prior Medication - Route
text
C2826257 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
Code List
Prior Medication - Route
CL Item
intra-articular (IA)
CL Item
intra-arterial (IAR)
CL Item
intra-dermal (ID)
CL Item
inhalation (IH)
CL Item
intra-muscular (IM)
CL Item
intra-thecal (IT)
CL Item
intra-venous (IV)
CL Item
nasal (NA)
CL Item
oral (PO)
CL Item
rectal (PR)
CL Item
subcutaneous (SC)
CL Item
sublingual (SL)
CL Item
transdermal (TD)
CL Item
topical (TO)
CL Item
vaginal (VA)
Prior Medication - Indication
Item
Prior Medication - Indication
text
C2826257 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prior Medication - Duration of Therapy
Item
Prior Medication - Duration of Therapy
text
C2826257 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
Prior Medication - End Date
Item
Prior Medication - End Date
date
C2826257 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Prior Medication - Continuing at end of study?
Item
Prior Medication - Continuing at end of study?
boolean
C2826257 (UMLS CUI [1,1])
C1553904 (UMLS CUI [1,2])
C2983670 (UMLS CUI [1,3])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Was a pregnancy test carried out?
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
If no pregnancy test was carried out, please specify reason
Item
If no pregnancy test was carried out, please specify reason
text
C0032976 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Was an alcohol breath test carried out?
Item
Was an alcohol breath test carried out?
boolean
C0202306 (UMLS CUI [1])
If no alcohol breath test was carried out, specify reason
Item
If no alcohol breath test was carried out, specify reason
text
C0202306 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
If alcohol breath test was carried out, indicate date of alcohol breath test
Item
If alcohol breath test was carried out, indicate date of alcohol breath test
date
C0202306 (UMLS CUI [1,1])
C001100 (UMLS CUI [1,2])
Item
Alcohol breath test result
integer
C0202306 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Code List
Alcohol breath test result
CL Item
Positive  (1)
CL Item
Negative (2)
Item Group
Drug Screening (Urine)
C0202274 (UMLS CUI-1)
Drug Screening (Urine) - Exact date end time of sampling
Item
Drug Screening (Urine) - Exact date end time of sampling
datetime
C0202274 (UMLS CUI [1])
C0870078 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Were there any contra-indicated drugs detected?
Item
Were there any contra-indicated drugs detected?
boolean
C1511790 (UMLS CUI [1,1])
C4036061 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])
Drug Screening (Urine) - Type of drug
Item
Drug Screening (Urine) - Type of drug
text
C0202274 (UMLS CUI [1])
C0457591 (UMLS CUI [2])
Drug Screening (Urine) - Comment
Item
Drug Screening (Urine) - Comment
text
C0202274 (UMLS CUI [1])
C0947611 (UMLS CUI [2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Date and Time
Item
Vital Signs - Date and Time
datetime
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Vital Signs - Semi-supine BP Systolic
Item
Vital Signs - Semi-supine BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine BP Diastolic
Item
Vital Signs - Semi-supine BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Semi-supine Hear Rate
Item
Vital Signs - Semi-supine Hear Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522019 (UMLS CUI [2,2])
Vital Signs - Time
Item
Vital Signs - Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vital Signs - Erect BP Systolic
Item
Vital Signs - Erect BP Systolic
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect BP Diastolic
Item
Vital Signs - Erect BP Diastolic
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])
Vital Signs - Erect Heart Rate
Item
Vital Signs - Erect Heart Rate
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2,1])
C0522014 (UMLS CUI [2,2])

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