ID

16667

Beschrijving

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

Trefwoorden

Versies (3)
  1. 30-07-16 30-07-16 -
  2. 25-11-16 25-11-16 -
  3. 20-06-18 20-06-18 - Julian Varghese
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30 juli 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Subject Off Study: CRF Wisconsin Madison

Engels

Subject Off Study: CRF Wisconsin Madison

1 Formulieren  
Header
Beschrijving

Header

PI Name
Beschrijving

PI Name

Datatype

text

IRB Number
Beschrijving

IRB Number

Datatype

integer

Short Title
Beschrijving

Short Title

Datatype

text

Subject Initials
Beschrijving

Subject Initials

Datatype

text

Subject ID
Beschrijving

Subject ID

Datatype

integer

Date
Beschrijving

Date

Datatype

date

Subject Off Study
Beschrijving

Subject Off Study

Date subject went Off Study
Beschrijving

Date

Datatype

date

Last visit completed
Beschrijving

Last visit

Datatype

text

Indicate the primary reason the subject is no longer participating in the study
Beschrijving

Primary reason

Datatype

text

Was subject treatment unblinded?
Beschrijving

Was subject treatment unblinded?

Datatype

text

Additional explanation required:
Beschrijving

Additional explanation required

Datatype

text

Form completed by
Beschrijving

Form completed by

Datatype

text

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Similar models

Subject Off Study: CRF Wisconsin Madison

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
PI Name
Item
PI Name
text
IRB Number
Item
IRB Number
integer
Short Title
Item
Short Title
text
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
integer
Date
Item
Date
date
Item Group
Subject Off Study
Date
Item
Date subject went Off Study
date
Item
Last visit completed
text
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
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
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
Form completed by
Item
Form completed by
text
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