Information:
Error:
ID
15866
Description
A simple trial to demonstrate the end-to-end application of the CDISC Standards
Keywords
Versions (1)
- 6/17/16 6/17/16 - Julian Varghese
Uploaded on
June 17, 2016
DOI
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License
Creative Commons BY-NC 3.0
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CDISC Example Study
Baseline
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Similar models
Baseline
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Site Number
Item
Site number
integer
SITEID (SDTM)
Subject ID
Item
Subject ID
text
USUBJID (SDTM)
Visit Date
Item
Visit Date
date
Visit Time
Item
Visit Start Time
time
Date of Birth
Item
Date of Birth
date
CL Item
Male (M)
CL.SEX Male (CDASH)
DM.SEX=M (SDTM)
DM.SEX=M (SDTM)
CL Item
Female (F)
CL.SEX Female (CDASH)
DM.SEX=F (SDTM)
DM.SEX=F (SDTM)
CL Item
Caucasian (CAUCASIAN)
CL Item
Black (BLACK)
CL Item
Asian (ASIAN)
CL Item
Other (OTHER)
Smoking
Item
Check when the subject is a smoker
boolean
CL Item
Less Than 10 cigarettes per day (LT10)
CL Item
10 to 20 cigarettes per day (10TO20)
CL Item
Greater Than 20 cigarettes per day (GT20)
CL Item
No (0)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Yes (1)
CL Item
No (0)
CL Item
Yes (1)
No. of illness days last year
Item
No. of illness days last year
integer
No. of bronchitis illnesses
Item
Number of bronchitis cases during the last year
integer
No. of pneunomia illnesses
Item
Number of pneumonia cases last year
integer
CL Item
Less Than 1 drink per day (LT1)
CL Item
1 to 2 drinks per day (1TO2)
CL Item
Greater Than 2 drinks per day (GT2)
Height
Item
Height
integer
VSORRES where VSTESTCD=HEIGHT (SDTM)
Weight
Item
Weight
integer
VSORRES where VSTESTCD=WEIGHT (SDTM)
BMI
Item
BMI
float
Systolic BP
Item
Systolic blood pressure
integer
VSORRES where VSTESTCD=SYSBP (SDTM)
SYSBP (CDASH)
SYSBP (CDASH)
Diastolic BP
Item
Diastolic blood pressure
integer
VSORRES where VSTESTCD=DIABP (SDTM)
Item
Does the subject feel dizzy when standing up from a sitting position
integer
CL Item
No (0)
CL Item
Yes (1)
Link to XRay
Item
Server or File location of X-Ray photograph
URI