ID

16540

Descripción

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

Palabras clave

  1. 23/7/16 23/7/16 -
  2. 17/11/16 17/11/16 -
Subido en

23 de julio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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Physical Examination: CRF Wisconsin Madison

Physical Examination: CRF Wisconsin Madison

Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Subject ID
Descripción

Subject ID

Tipo de datos

text

Exam Date
Descripción

Exam Date

Tipo de datos

date

Physical Examination
Descripción

Physical Examination

Time
Descripción

Time

Tipo de datos

time

Physical Examination not performed
Descripción

Physical Examination not performed

Tipo de datos

boolean

Visit Number
Descripción

Visit Number

Tipo de datos

text

Body System
Descripción

Body System

Body system to be examined
Descripción

Body System

Tipo de datos

text

Finding
Descripción

Finding

Tipo de datos

text

Comments (required if Abnormal)
Descripción

Comments

Tipo de datos

text

Clinically Significant
Descripción

Clinically Significant

Tipo de datos

boolean

Other
Descripción

Other

Other (specify in Comments)
Descripción

Other

Tipo de datos

text

Finding
Descripción

Finding

Tipo de datos

text

Comments (required if Abnormal)
Descripción

Comments

Tipo de datos

text

Clinically Significant
Descripción

Clinically Significant

Tipo de datos

boolean

Additional notes
Descripción

Additional notes

Tipo de datos

text

Physical Examination performed by
Descripción

Physical Examination performed by

Tipo de datos

text

Principal Investigator Signature
Descripción

Principal Investigator Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Similar models

Physical Examination: CRF Wisconsin Madison

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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