ID

16533

Beskrivning

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.

Länk

https://ictr.wisc.edu/CaseReptTempt

Nyckelord

Versioner (2)
  1. 2016-07-22 2016-07-22 -
  2. 2016-11-17 2016-11-17 -
Uppladdad den

22 juli 2016

DOI

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Licens

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

Engelsk

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Subject ID
Beskrivning

Subject ID

Datatyp

integer

Informed Consent/HIPAA Authorized Obtained
Beskrivning

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Beskrivning

Consent Refused

Datatyp

boolean

Date Signed
Beskrivning

Date Signed

Datatyp

date

Time
Beskrivning

Time

Datatyp

time

Document(s) signed
Beskrivning

Document(s) signed

Document(s) signed
Beskrivning

Document(s) signed

Datatyp

text

Version Date
Beskrivning

Version Date

Datatyp

date

Approval Date
Beskrivning

Approval Date

Datatyp

date

Expiration Date
Beskrivning

Expiration Date

Datatyp

date

undefined itemgroup
Beskrivning

undefined itemgroup

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

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

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

Datatyp

boolean

Name of the person that obtained consent
Beskrivning

Name of the person that obtained consent

Datatyp

text

Comments
Beskrivning

Comments

Datatyp

text

Informed Consent Refused
Beskrivning

Informed Consent Refused

Time
Beskrivning

Time

Datatyp

time

Not Applicable
Beskrivning

Not Applicable

Datatyp

boolean

Comments
Beskrivning

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

Datatyp

text

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Similar models

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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