Information:
Fel:
ID
26206
Beskrivning
A sample trial to demonstrate the end-to-end application of the CDISC Standards and transformations from ADL
Nyckelord
Versioner (1)
- 2017-10-11 2017-10-11 -
Rättsinnehavare
Unknown
Uppladdad den
11 oktober 2017
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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Sample 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
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
DM - Sex
Item
Sex
text
DM - Race
Item
Race
text
Smoking
Item
Check when the subject is a smoker
boolean
Number of cigarettes per day
Item
Number of cigarettes per day
text
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
Height
Item
Height
integer
VSORRES where VSTESTCD=HEIGHT (SDTM)
Weight
Item
Weight
integer
VSORRES where VSTESTCD=WEIGHT (SDTM)
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