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 Visit Form

Common
Description

Common

Alias
TEST
Common ItemGroup Alias
Site Number
Description

Site Number

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 Time
Description

Visit Time

Data type

time

Demographics
Description

Demographics

Alias
SDTM
DM
Date of Birth
Description

Date of Birth

Data type

date

DM - Sex
Description

DM - Sex

Data type

text

DM - Race
Description

DM - Race

Data type

text

Smoking History
Description

Smoking History

Smoking
Description

Smoking

Data type

boolean

Number of cigarettes per day
Description

Number of cigarettes per day

Data type

text

Complaints due to smoking
Description

Complaints due to smoking

Breath complaints
Description

Breath complaints

Data type

integer

Coughing problems
Description

Coughing problems

Data type

integer

Hart complaints
Description

Hart complaints

Data type

integer

No. of illness days last year
Description

No. of illness days last year

Data type

integer

No. of bronchitis illnesses
Description

No. of bronchitis illnesses

Data type

integer

No. of pneunomia illnesses
Description

No. of pneunomia illnesses

Data type

integer

Drinking History
Description

Drinking History

Drinking
Description

Drinking

Data type

text

  1. < 1
  2. 1-2
  3. > 2
Physical Exam
Description

Physical Exam

Height
Description

Height

Data type

integer

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

Weight

Data type

integer

Measurement units
  • Pounds
Alias
SDTM
VSORRES where VSTESTCD=WEIGHT
Pounds
Systolic BP
Description

Systolic BP

Data type

integer

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

Diastolic BP

Data type

integer

Measurement units
  • mm Hg
Alias
SDTM
VSORRES where VSTESTCD=DIABP
mm Hg
Dizzyness at low DBP
Description

Dizzyness at low DBP

Data type

integer

XRay
Description

XRay

Link to XRay
Description

Link to XRay

Data type

URI

Similar models

Baseline Visit Form

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Common ItemGroup Alias (TEST)
Site Number
Item
integer
SITEID (SDTM)
Subject ID
Item
text
USUBJID (SDTM)
Visit Date
Item
date
Visit Time
Item
time
Item Group
DM (SDTM)
Date of Birth
Item
date
DM - Sex
Item
text
DM - Race
Item
text
Smoking
Item
boolean
Number of cigarettes per day
Item
text
Item
integer
Code List
Breath complaints
CL Item
 (0)
CL Item
 (1)
Item
integer
Code List
Coughing problems
CL Item
 (0)
CL Item
 (1)
Item
integer
Code List
Hart complaints
CL Item
 (0)
CL Item
 (1)
No. of illness days last year
Item
integer
No. of bronchitis illnesses
Item
integer
No. of pneunomia illnesses
Item
integer
Item
text
Code List
Drinking
Item Group
Height
Item
integer
VSORRES where VSTESTCD=HEIGHT (SDTM)
Weight
Item
integer
VSORRES where VSTESTCD=WEIGHT (SDTM)
Systolic BP
Item
integer
VSORRES where VSTESTCD=SYSBP (SDTM)
SYSBP (CDASH)
Diastolic BP
Item
integer
VSORRES where VSTESTCD=DIABP (SDTM)
Code List
Dizzyness at low DBP
CL Item
 (0)
CL Item
 (1)
Item Group
Link to XRay
Item
URI

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