ID

30792

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Off Study. 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

Versions (3)
  1. 7/30/16 7/30/16 -
  2. 11/25/16 11/25/16 -
  3. 6/20/18 6/20/18 - Julian Varghese
Copyright Holder

Wisconsin Madison

Uploaded on

June 20, 2018

DOI

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License

Creative Commons BY 3.0
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Subject Off Study: CRF Wisconsin Madison

English

Subject Off Study: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1521895
IRB Number
Description

IRB Number

Data type

integer

Alias
UMLS CUI [1,1]
C0086911
UMLS CUI [1,2]
C0237753
Short Title
Description

Protocol Short Title

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1705824
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Subject Off Study
Description

Subject Off Study

Date subject went Off Study
Description

Off Study Date

Data type

date

Alias
UMLS CUI [1]
C2985813
Last visit completed
Description

Last visit

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0205197
Indicate the primary reason the subject is no longer participating in the study
Description

Primary reason

Data type

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C2348570
Was subject treatment unblinded?
Description

Was subject treatment unblinded?

Data type

text

Alias
UMLS CUI [1]
C2826259
Additional explanation required:
Description

Additional explanation required

Data type

text

Alias
UMLS CUI [1,1]
C0681841
UMLS CUI [1,2]
C1524062
Form completed by
Description

Form completed by

Data type

text

Alias
UMLS CUI [1]
C1550483
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Similar models

Subject Off Study: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
IRB Number
Item
IRB Number
integer
C0086911 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Protocol Short Title
Item
Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Subject Off Study
Off Study Date
Item
Date subject went Off Study
date
C2985813 (UMLS CUI [1])
Item
Last visit completed
text
C0545082 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Last visit
Code List
Last visit completed
CL Item
Screening visit (1)
CL Item
Visit 1 (2)
CL Item
Visit 2 (3)
Item
Indicate the primary reason the subject is no longer participating in the study
text
C1549995 (UMLS CUI [1,1])
C2348570 (UMLS CUI [1,2])
Primary reason
Code List
Indicate the primary reason the subject is no longer participating in the study
CL Item
Study Activities Completed (1)
CL Item
Subject Withdrawn (by subject) PRIOR to enrollment (i.e. subject deemed eligible but declined participation, etc.) Additional explanation required.  (2)
CL Item
Subject Withdrawn (by subject) AFTER enrollment (i.e. due to personal time constraints, etc.) Additional explanation required.  (3)
CL Item
Subject Withdrawn (by PI or study team) PRIOR to enrollment (i.e. subject deemed inappropriate for study participation by the PI or study team, explain below) (4)
CL Item
Subject Withdrawn (by PI or study team) AFTER enrollment (i.e. identification of disease/condition after enrollment that warrants withdrawal, participant was determined to be ineligible after enrollment etc.) (5)
CL Item
Adverse Events/Side effects/Complications (complete Adverse Tracking Log) Additional explanation required.  (6)
CL Item
Other. Additional explanation required. (7)
Item
Was subject treatment unblinded?
text
C2826259 (UMLS CUI [1])
Was subject treatment unblinded?
Code List
Was subject treatment unblinded?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Additional explanation required
Item
Additional explanation required:
text
C0681841 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Form completed by
Item
Form completed by
text
C1550483 (UMLS CUI [1])
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