ID

16533

Beschreibung

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

Stichworte

Versionen (2)
  1. 22.07.16 22.07.16 -
  2. 17.11.16 17.11.16 -
Hochgeladen am

22. Juli 2016

DOI

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

Englisch

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulare  
Header
Beschreibung

Header

PI Name
Beschreibung

PI Name

Datentyp

text

Protocol or IRB Number
Beschreibung

Protocol or IRB Number

Datentyp

integer

Protocol Short Title
Beschreibung

Protocol Short Title

Datentyp

text

Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Subject ID
Beschreibung

Subject ID

Datentyp

integer

Informed Consent/HIPAA Authorized Obtained
Beschreibung

Informed Consent/HIPAA Authorized Obtained

Consent Refused
Beschreibung

Consent Refused

Datentyp

boolean

Date Signed
Beschreibung

Date Signed

Datentyp

date

Time
Beschreibung

Time

Datentyp

time

Document(s) signed
Beschreibung

Document(s) signed

Document(s) signed
Beschreibung

Document(s) signed

Datentyp

text

Version Date
Beschreibung

Version Date

Datentyp

date

Approval Date
Beschreibung

Approval Date

Datentyp

date

Expiration Date
Beschreibung

Expiration Date

Datentyp

date

undefined itemgroup
Beschreibung

undefined itemgroup

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

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

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

Datentyp

boolean

Name of the person that obtained consent
Beschreibung

Name of the person that obtained consent

Datentyp

text

Comments
Beschreibung

Comments

Datentyp

text

Informed Consent Refused
Beschreibung

Informed Consent Refused

Time
Beschreibung

Time

Datentyp

time

Not Applicable
Beschreibung

Not Applicable

Datentyp

boolean

Comments
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

Informed Consent/HIPAA Authorization Obtained: CRF Wisconsin Madison

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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