ID

16996

Description

ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Protocol Deviations Log. University of Alberta, Quality Management in Clinical Research. Copyright: 2002-2016 University of Alberta.

Link

http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx

Keywords

  1. 8/19/16 8/19/16 -
Uploaded on

August 19, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Protocol Deviations Log: CRF QMCR University of Alberta

Protocol Deviations Log: CRF QMCR University of Alberta

General Information
Description

General Information

Study Name
Description

Study Name

Data type

text

Site Number
Description

Site Number

Data type

integer

Pt_ID
Description

Pt_ID

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Did this participant have any protocol deviations?
Description

Did this participant have any protocol deviations?

Data type

boolean

Protocol Deviations
Description

Protocol Deviations

Description of Protocol Deviation
Description

Description of Protocol Deviation

Data type

text

Deviation Category (See Description)
Description

A. Safety B. Informed Consent C. Eligibility D. Protocol implementation E. Other, specify in log

Data type

text

Deviation Code
Description

Deviation Code

Data type

integer

Date Deviation Occurred
Description

Date Deviation Occurred

Data type

date

Date IRB Notified (if applicable)
Description

Date IRB Notified (if applicable)

Data type

date

Principal Investigator´s Signature
Description

Principal Investigator´s Signature

Data type

text

Date Signed
Description

Date Signed

Data type

date

Similar models

Protocol Deviations Log: CRF QMCR University of Alberta

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Study Name
Item
Study Name
text
Site Number
Item
Site Number
integer
Pt_ID
Item
Pt_ID
integer
Visit Date
Item
Visit Date
date
Did this participant have any protocol deviations?
Item
Did this participant have any protocol deviations?
boolean
Item Group
Protocol Deviations
Description of Protocol Deviation
Item
Description of Protocol Deviation
text
Deviation Category (See Description)
Item
Deviation Category (See Description)
text
Deviation Code
Item
Deviation Code
integer
Date Deviation Occurred
Item
Date Deviation Occurred
date
Date IRB Notified (if applicable)
Item
Date IRB Notified (if applicable)
date
Principal Investigator´s Signature
Item
Principal Investigator´s Signature
text
Date Signed
Item
Date Signed
date

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