ID

16975

Description

ODM derived from: http://www.qmcr.ualberta.ca/en/ToolsandTemplates/CaseReportFormCRFTemplates.aspx. Template Name: Adverse Events. 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. 8/17/16 8/17/16 -
Uploaded on

August 17, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Adverse Events: CRF QMCR University of Alberta

Adverse Events: 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

Has the participant had any Adverse Events during this Study? (see Description)
Description

If yes, please list all Adverse Events below.

Data type

boolean

Adverse Events
Description

Adverse Events

Adverse Event
Description

Adverse Event

Data type

text

Start Date
Description

Start Date

Data type

date

Stop Date
Description

Stop Date

Data type

date

Severity
Description

Severity

Data type

text

Relationship to Study Treatment
Description

Relationship to Study Treatment

Data type

text

Action Taken (see Description)
Description

1= None 2= Discontinued permanently 3= Discontinued temporarily 4= Reduced Dose 5= Increased Dose 6= Delayed Dose

Data type

integer

Outcome of AE (see Description)
Description

1= Resolved, No Sequel 2= AE still present - no treatment 3= AE still present - being treated 4= Residual effects present - not treated 5= Residual effects present - treated 6= Death 7= Unknown

Data type

integer

Expected?
Description

Expected?

Data type

boolean

Serious Adverse Event
Description

Serious Adverse Event

Data type

text

Initials
Description

Initials

Data type

text

Similar models

Adverse Events: 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
Has the participant had any Adverse Events during this Study? (see Description)
Item
Has the participant had any Adverse Events during this Study? (see Description)
boolean
Item Group
Adverse Events
Adverse Event
Item
Adverse Event
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Item
Severity
text
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Treatment
text
Code List
Relationship to Study Treatment
CL Item
Definitely related (1)
CL Item
Possibly related (2)
CL Item
Not related (3)
Action Taken (see Description)
Item
Action Taken (see Description)
integer
Outcome of AE (see Description)
Item
Outcome of AE (see Description)
integer
Expected?
Item
Expected?
boolean
Item
Serious Adverse Event
text
Code List
Serious Adverse Event
CL Item
Yes (complete SAE form) (1)
CL Item
No (2)
Initials
Item
Initials
text

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial