ID

16533

Descrizione

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.

collegamento

https://ictr.wisc.edu/CaseReptTempt

Keywords

versioni (2)
  1. 22/07/16 22/07/16 -
  2. 17/11/16 17/11/16 -
Caricato su

22 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 moduli  
Header
Descrizione

Header

PI Name
Descrizione

PI Name

Tipo di dati

text

Protocol or IRB Number
Descrizione

Protocol or IRB Number

Tipo di dati

integer

Protocol Short Title
Descrizione

Protocol Short Title

Tipo di dati

text

Subject Initials
Descrizione

Subject Initials

Tipo di dati

text

Subject ID
Descrizione

Subject ID

Tipo di dati

integer

Informed Consent/HIPAA Authorized Obtained
Descrizione

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Descrizione

Consent Refused

Tipo di dati

boolean

Date Signed
Descrizione

Date Signed

Tipo di dati

date

Time
Descrizione

Time

Tipo di dati

time

Document(s) signed
Descrizione

Document(s) signed

Document(s) signed
Descrizione

Document(s) signed

Tipo di dati

text

Version Date
Descrizione

Version Date

Tipo di dati

date

Approval Date
Descrizione

Approval Date

Tipo di dati

date

Expiration Date
Descrizione

Expiration Date

Tipo di dati

date

undefined itemgroup
Descrizione

undefined itemgroup

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

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

Tipo di dati

boolean

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

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

Tipo di dati

boolean

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

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

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Name of the person that obtained consent
Descrizione

Name of the person that obtained consent

Tipo di dati

text

Comments
Descrizione

Comments

Tipo di dati

text

Informed Consent Refused
Descrizione

Informed Consent Refused

Time
Descrizione

Time

Tipo di dati

time

Not Applicable
Descrizione

Not Applicable

Tipo di dati

boolean

Comments
Descrizione

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

Tipo di dati

text

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Similar models

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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