Informações:
Falhas:
ID
16639
Descrição
ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Telephone Contact. 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
Palavras-chave
Versões (1)
- 27/07/2016 27/07/2016 -
Transferido a
27 de julho de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Telephone Contact: CRF Wisconsin Madison
Telephone Contact: CRF Wisconsin Madison
- StudyEvent: ODM
Similar models
Telephone Contact: CRF Wisconsin Madison
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
PI (Last Name, First Name)
Item
PI (Last Name, First Name)
text
IRB Number
Item
IRB Number
integer
Short Title
Item
Short Title
text
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
integer
Date
Item
Date
date
Telephone Contact
Item
Telephone contact not performed, If Telephone contact not performed, complete the Subject Deviation Form
boolean
Date of Contact Attempt
Item
Date of Contact Attempt
date
Time
Item
Time: AM
boolean
Time
Item
Time: PM
boolean
Contact Occurred
Item
Contact Occurred
boolean
CL Item
No Answer (1)
CL Item
Left Voice Message (2)
CL Item
Left Message w/___ (3)
CL Item
Line Busy (4)
CL Item
Other___ (5)
Outcome
Item
If Left Message please specify with who
text
Outcome
Item
If Other, please specify
text
Date of Contact Attempt
Item
Date of Contact Attempt
date
Time
Item
Time: AM
boolean
Time
Item
Time: PM
boolean
Contact Occurred
Item
Contact Occurred
boolean
CL Item
No Answer (1)
CL Item
Left Voice Message (2)
CL Item
Left Message w/___ (3)
CL Item
Line Busy (4)
CL Item
Other___ (5)
Outcome
Item
If Left Message, please specify with who
text
Outcome
Item
If Other, please specify
text
Date of Contact Attempt
Item
Date of Contact Attempt
date
Time
Item
Time: AM
boolean
Time
Item
Time: PM
boolean
Contact Occurred
Item
Contact Occurred
boolean
CL Item
No Answer (1)
CL Item
Left Voice Message (2)
CL Item
Left Message w/___ (3)
CL Item
Line Busy (4)
CL Item
Other___ (5)
Outcome
Item
If Left Message, please specify with who
text
Outcome
Item
If Other, please specify
text
Date of Contact Attempt
Item
Date of Contact Attempt
date
Time
Item
Time: AM
boolean
Time
Item
Time: PM
boolean
Contact Occurred
Item
Contact Occurred
boolean
CL Item
No Answer (1)
CL Item
Left Voice Message (2)
CL Item
Left Message w/___ (3)
CL Item
Line Busy (4)
CL Item
Other___ (5)
Outcome
Item
If Left Message, please specify with who
text
Outcome
Item
If Other, please specify
text
Date telephone Contact completed
Item
Date telephone Contact completed
date
Insert text as reminders to research staff
Item
Insert text as reminders to research staff
text
Changes in health status
Item
Since your last study contact, have you had any changes in health status, medical conditions, or adverse events?
boolean
Changes in health status
Item
Changes in health status : Form No.
integer
Concomitant Medications
Item
Concomitant Medications Log completed (if applicable)?
boolean
Concomitant Medications
Item
Concomitant Medications: Form No.
integer
Adverse Event Symptoms reviewed with Subject?
Item
Adverse Event Symptoms reviewed with Subject?
boolean
Adverse Event Symptoms reviewed with Subject?
Item
Adverse Event Symptoms reviewed with Subject?: Form No.
integer
Adverse event tracking log
Item
Adverse event tracking log completed (same log from all visits)?
boolean
Adverse event tracking log
Item
Adverse event tracking log completed?: Form No.
integer
Specification
Item
If any AE has "Yes" in Serious column, complete SAE form and enter the information in Subject Console > SAE screen of OnCore?
boolean
Specification
Item
If any AE has "Yes" in Serious column, complete SAE form and enter the information in Subject Console > SAE screen of OnCore?: Form No.
integer
Medical history form
Item
Does the medical history form need to be updated?
boolean
Medical history form
Item
Does the medical history form need to be updated?: Form No.
integer
Deviating activities
Item
Were there any activities that deviated from the defined protocol?
boolean
Deviating activities
Item
Were there any activities that deviated from the defined protocol?: Form No.
integer
Specification
Item
If yes, completed the Deviation/Violation form and enter the information in the Subject Console > Deviations screen of OnCore?
boolean
Specification
Item
If yes, completed the Deviation/Violation form and enter the information in the Subject Console > Deviations screen of OnCore?: Form No.
integer
Subject payment
Item
Subject payment confirmed (if applicable)
boolean
Subject payment
Item
Subject payment confirmed (if applicable): Form No.
integer
Other Questions
Item
Other Question to ask (if applicable)
boolean
Other Questions
Item
Other Questions to ask (if applicable): Form No.
integer
Comments
Item
Comments
text
Telephone contact conduced by
Item
Telephone contact conduced by
text
Form completed by
Item
Form completed by
text
Date
Item
Date
date