ID

16533

Beschrijving

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

Trefwoorden

Versies (2)
  1. 22-07-16 22-07-16 -
  2. 17-11-16 17-11-16 -
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22 juli 2016

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

Engels

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulieren  
Header
Beschrijving

Header

PI Name
Beschrijving

PI Name

Datatype

text

Protocol or IRB Number
Beschrijving

Protocol or IRB Number

Datatype

integer

Protocol Short Title
Beschrijving

Protocol Short Title

Datatype

text

Subject Initials
Beschrijving

Subject Initials

Datatype

text

Subject ID
Beschrijving

Subject ID

Datatype

integer

Informed Consent/HIPAA Authorized Obtained
Beschrijving

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Beschrijving

Consent Refused

Datatype

boolean

Date Signed
Beschrijving

Date Signed

Datatype

date

Time
Beschrijving

Time

Datatype

time

Document(s) signed
Beschrijving

Document(s) signed

Document(s) signed
Beschrijving

Document(s) signed

Datatype

text

Version Date
Beschrijving

Version Date

Datatype

date

Approval Date
Beschrijving

Approval Date

Datatype

date

Expiration Date
Beschrijving

Expiration Date

Datatype

date

undefined itemgroup
Beschrijving

undefined itemgroup

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

Name of the person that obtained consent
Beschrijving

Name of the person that obtained consent

Datatype

text

Comments
Beschrijving

Comments

Datatype

text

Informed Consent Refused
Beschrijving

Informed Consent Refused

Time
Beschrijving

Time

Datatype

time

Not Applicable
Beschrijving

Not Applicable

Datatype

boolean

Comments
Beschrijving

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

Datatype

text

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Similar models

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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