ID

18728

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Informed Consent/HIPAA Authorization Obtained. 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 (2)
  1. 7/22/16 7/22/16 -
  2. 11/17/16 11/17/16 -
Uploaded on

November 17, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

English

Informed Consent/HIPAA Authorization Obtained: 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
Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Alias
UMLS CUI [1]
C2348563
Protocol 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
Informed Consent/HIPAA Authorized Obtained
Description

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Description

Consent Refused

Data type

boolean

Alias
UMLS CUI [1]
C1548946
Date Signed
Description

Date Signed

Data type

date

Alias
UMLS CUI [1]
C3262251
Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Document(s) signed
Description

Document(s) signed

Document(s) signed
Description

Document(s) signed

Data type

text

Alias
UMLS CUI [1]
C1519316
Version Date
Description

Version Date

Data type

date

Alias
UMLS CUI [1]
C2985902
Approval Date
Description

Approval Date

Data type

date

Alias
UMLS CUI [1]
C2346844
Expiration Date
Description

Expiration Date

Data type

date

Alias
UMLS CUI [1]
C3669020
undefined itemgroup
Description

undefined itemgroup

Consent Form, and related study documents, was thoroughly reviewed with the subject.
Description

Consent Form, and related study documents, was thoroughly reviewed with the subject.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009797
UMLS CUI [1,2]
C1709941
UMLS CUI [1,3]
C0681850
Subject had sufficient time to review the documents and ask questions.
Description

Subject had sufficient time to review the documents and ask questions.

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0205410
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
Description

Informed consent/HIPAA Authorization obtained prior to any study related procedures.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
A copy of the signed documents have been given to the subject.
Description

A copy of the signed documents have been given to the subject.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009797
UMLS CUI [1,2]
C1561610
UMLS CUI [1,3]
C1948062
Name of the person that obtained consent
Description

Name of the person that obtained consent

Data type

text

Alias
UMLS CUI [1]
C0027365
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Informed Consent Refused
Description

Informed Consent Refused

Time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Not Applicable
Description

Not Applicable

Data type

boolean

Alias
UMLS CUI [1]
C1272460
Comments
Description

This form should be completed for each Informed Consent process (i.e. if Re-consented)

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Informed Consent/HIPAA Authorization Obtained: 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])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol 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])
Item Group
Informed Consent/HIPAA Authorized Obtained
Consent Refused
Item
Consent Refused
boolean
C1548946 (UMLS CUI [1])
Date Signed
Item
Date Signed
date
C3262251 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item Group
Document(s) signed
Document(s) signed
Item
Document(s) signed
text
C1519316 (UMLS CUI [1])
Version Date
Item
Version Date
date
C2985902 (UMLS CUI [1])
Approval Date
Item
Approval Date
date
C2346844 (UMLS CUI [1])
Expiration Date
Item
Expiration Date
date
C3669020 (UMLS CUI [1])
Consent Form, and related study documents, was thoroughly reviewed with the subject.
Item
Consent Form, and related study documents, was thoroughly reviewed with the subject.
boolean
C0009797 (UMLS CUI [1,1])
C1709941 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
Subject had sufficient time to review the documents and ask questions.
Item
Subject had sufficient time to review the documents and ask questions.
boolean
C0040223 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
Item
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
boolean
C0021430 (UMLS CUI [1])
A copy of the signed documents have been given to the subject.
Item
A copy of the signed documents have been given to the subject.
boolean
C0009797 (UMLS CUI [1,1])
C1561610 (UMLS CUI [1,2])
C1948062 (UMLS CUI [1,3])
Name of the person that obtained consent
Item
Name of the person that obtained consent
text
C0027365 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Informed Consent Refused
Time
Item
time
C0040223 (UMLS CUI [1])
Not Applicable
Item
Not Applicable
boolean
C1272460 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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