ID

16533

Descripción

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

Palabras clave

Versiones (2)
  1. 22/7/16 22/7/16 -
  2. 17/11/16 17/11/16 -
Subido en

22 de julio de 2016

DOI

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Licencia

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

Inglés

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 formularios  
Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Subject ID
Descripción

Subject ID

Tipo de datos

integer

Informed Consent/HIPAA Authorized Obtained
Descripción

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Descripción

Consent Refused

Tipo de datos

boolean

Date Signed
Descripción

Date Signed

Tipo de datos

date

Time
Descripción

Time

Tipo de datos

time

Document(s) signed
Descripción

Document(s) signed

Document(s) signed
Descripción

Document(s) signed

Tipo de datos

text

Version Date
Descripción

Version Date

Tipo de datos

date

Approval Date
Descripción

Approval Date

Tipo de datos

date

Expiration Date
Descripción

Expiration Date

Tipo de datos

date

undefined itemgroup
Descripción

undefined itemgroup

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

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

Tipo de datos

boolean

Name of the person that obtained consent
Descripción

Name of the person that obtained consent

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

Informed Consent Refused
Descripción

Informed Consent Refused

Time
Descripción

Time

Tipo de datos

time

Not Applicable
Descripción

Not Applicable

Tipo de datos

boolean

Comments
Descripción

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

Tipo de datos

text

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Similar models

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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