ID

26206

Description

A sample trial to demonstrate the end-to-end application of the CDISC Standards and transformations from ADL

Keywords

  1. 10/11/17 10/11/17 -
Copyright Holder

Unknown

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY-NC-ND 3.0

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Sample Study

Baseline

Common
Description

Common

Alias
TEST
Common ItemGroup Alias
Site number
Description

Site Number as assigned by CRO

Data type

integer

Alias
SDTM
SITEID
Subject ID
Description

Subject ID

Data type

text

Alias
SDTM
USUBJID
Visit Date
Description

Visit Date

Data type

date

Visit Start Time
Description

Visit Time

Data type

time

Demographics
Description

Demographics

Alias
SDTM
DM
Date of Birth
Description

Date of Birth

Data type

date

Sex
Description

DM - Sex

Data type

text

Race
Description

DM - Race

Data type

text

Smoking History
Description

Smoking History

Check when the subject is a smoker
Description

Smoking

Data type

boolean

Number of cigarettes per day
Description

Number of cigarettes per day

Data type

text

Complaints related to smoking
Description

Complaints related to smoking

Breathing
Description

Breath complaints

Data type

integer

Coughing
Description

Coughing problems

Data type

integer

Heart
Description

Hart complaints

Data type

integer

No. of illness days last year
Description

No. of illness days last year

Data type

integer

Number of bronchitis cases during the last year
Description

No. of bronchitis illnesses

Data type

integer

Number of pneumonia cases last year
Description

No. of pneunomia illnesses

Data type

integer

Drinking history
Description

Drinking history

Number of alcoholic drinks per day
Description

Drinking

Data type

text

  1. < 1
  2. 1-2
  3. > 2
Physical examination: Base
Description

Physical examination: Base

Height
Description

Height

Data type

integer

Measurement units
  • in
Alias
SDTM
VSORRES where VSTESTCD=HEIGHT
in
Weight
Description

Weight

Data type

integer

Measurement units
  • lbs
Alias
SDTM
VSORRES where VSTESTCD=WEIGHT
lbs
Systolic blood pressure
Description

Systolic BP

Data type

integer

Measurement units
  • mm Hg
Alias
SDTM
VSORRES where VSTESTCD=SYSBP
CDASH
SYSBP
mm Hg
Diastolic blood pressure
Description

Diastolic BP

Data type

integer

Measurement units
  • mm Hg
Alias
SDTM
VSORRES where VSTESTCD=DIABP
mm Hg
Does the subject feel dizzy when standing up from a sitting position
Description

Dizzyness at low DBP

Data type

integer

X-Ray
Description

X-Ray

Server or File location of X-Ray photograph
Description

Link to XRay

Data type

URI

Similar models

Baseline

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Common
Common ItemGroup Alias (TEST)
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
Item Group
Demographics
DM (SDTM)
Date of Birth
Item
Date of Birth
date
DM - Sex
Item
Sex
text
DM - Race
Item
Race
text
Item Group
Smoking History
Smoking
Item
Check when the subject is a smoker
boolean
Number of cigarettes per day
Item
Number of cigarettes per day
text
Item Group
Complaints related to smoking
Item
Breathing
integer
Code List
Breathing
CL Item
No (0)
CL Item
Yes (1)
Item
Coughing
integer
Code List
Coughing
CL Item
No (0)
CL Item
Yes (1)
Item
Heart
integer
Code List
Heart
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
Item Group
Drinking history
Item
Number of alcoholic drinks per day
text
Code List
Number of alcoholic drinks per day
Item Group
Physical examination: Base
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)
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
Code List
Does the subject feel dizzy when standing up from a sitting position
CL Item
No (0)
CL Item
Yes (1)
Item Group
X-Ray
Link to XRay
Item
Server or File location of X-Ray photograph
URI

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