ID

16540

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Physical Examination. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Keywords

  1. 7/23/16 7/23/16 -
  2. 11/17/16 11/17/16 -
Uploaded on

July 23, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Physical Examination: CRF Wisconsin Madison

Physical Examination: CRF Wisconsin Madison

Header
Description

Header

PI Name
Description

PI Name

Data type

text

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

Subject Initials
Description

Subject Initials

Data type

text

Subject ID
Description

Subject ID

Data type

text

Exam Date
Description

Exam Date

Data type

date

Physical Examination
Description

Physical Examination

Time
Description

Time

Data type

time

Physical Examination not performed
Description

Physical Examination not performed

Data type

boolean

Visit Number
Description

Visit Number

Data type

text

Body System
Description

Body System

Body system to be examined
Description

Body System

Data type

text

Finding
Description

Finding

Data type

text

Comments (required if Abnormal)
Description

Comments

Data type

text

Clinically Significant
Description

Clinically Significant

Data type

boolean

Other
Description

Other

Other (specify in Comments)
Description

Other

Data type

text

Finding
Description

Finding

Data type

text

Comments (required if Abnormal)
Description

Comments

Data type

text

Clinically Significant
Description

Clinically Significant

Data type

boolean

Additional notes
Description

Additional notes

Data type

text

Physical Examination performed by
Description

Physical Examination performed by

Data type

text

Principal Investigator Signature
Description

Principal Investigator Signature

Data type

text

Date
Description

Date

Data type

date

Similar models

Physical Examination: CRF Wisconsin Madison

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PI Name
Item
PI Name
text
Protocol or IRB Number
Item
Protocol or IRB Number
integer
Protocol Short Title
Item
Protocol Short Title
text
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
text
Exam Date
Item
Exam Date
date
Item Group
Physical Examination
Time
Item
Time
time
Physical Examination not performed
Item
Physical Examination not performed
boolean
Item
Visit Number
text
Code List
Visit Number
CL Item
Visit # (1)
CL Item
Visit # (2)
CL Item
Visit # (3)
CL Item
Visit # (4)
CL Item
Visit # (5)
CL Item
Visit # (6)
Item Group
Body System
Body System
Item
Body system to be examined
text
Item
Finding
text
Code List
Finding
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Comments
Item
Comments (required if Abnormal)
text
Clinically Significant
Item
Clinically Significant
boolean
Item Group
Other
Other
Item
Other (specify in Comments)
text
Item
Finding
text
Code List
Finding
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not examined (3)
Comments
Item
Comments (required if Abnormal)
text
Clinically Significant
Item
Clinically Significant
boolean
Additional notes
Item
Additional notes
text
Physical Examination performed by
Item
Physical Examination performed by
text
Principal Investigator Signature
Item
Principal Investigator Signature
text
Date
Item
Date
date

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