ID

16533

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

July 22, 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

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

integer

Informed Consent/HIPAA Authorized Obtained
Description

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Description

Consent Refused

Data type

boolean

Date Signed
Description

Date Signed

Data type

date

Time
Description

Time

Data type

time

Document(s) signed
Description

Document(s) signed

Document(s) signed
Description

Document(s) signed

Data type

text

Version Date
Description

Version Date

Data type

date

Approval Date
Description

Approval Date

Data type

date

Expiration Date
Description

Expiration Date

Data type

date

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

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

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

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

Name of the person that obtained consent
Description

Name of the person that obtained consent

Data type

text

Comments
Description

Comments

Data type

text

Informed Consent Refused
Description

Informed Consent Refused

Time
Description

Time

Data type

time

Not Applicable
Description

Not Applicable

Data type

boolean

Comments
Description

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

Data type

text

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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
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
integer
Item Group
Informed Consent/HIPAA Authorized Obtained
Consent Refused
Item
Consent Refused
boolean
Date Signed
Item
Date Signed
date
Time
Item
Time
time
Item Group
Document(s) signed
Document(s) signed
Item
Document(s) signed
text
Version Date
Item
Version Date
date
Approval Date
Item
Approval Date
date
Expiration Date
Item
Expiration Date
date
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
Subject had sufficient time to review the documents and ask questions.
Item
Subject had sufficient time to review the documents and ask questions.
boolean
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
Item
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
boolean
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
Name of the person that obtained consent
Item
Name of the person that obtained consent
text
Comments
Item
Comments
text
Item Group
Informed Consent Refused
Time
Item
time
Not Applicable
Item
Not Applicable
boolean
Comments
Item
Comments
text
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