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Adverse Events: CRF QMCR University of Alberta

1 formularios  
General Information
Descripción

General Information

Study Name
Descripción

Study Name

Tipo de datos

text

Site Number
Descripción

Site Number

Tipo de datos

integer

Pt_ID
Descripción

Pt_ID

Tipo de datos

integer

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

If yes, please list all Adverse Events below.

Tipo de datos

boolean

Adverse Events
Descripción

Adverse Events

Adverse Event
Descripción

Adverse Event

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

Stop Date
Descripción

Stop Date

Tipo de datos

date

Severity
Descripción

Severity

Tipo de datos

text

Relationship to Study Treatment
Descripción

Relationship to Study Treatment

Tipo de datos

text

Action Taken (see Description)
Descripción

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

Tipo de datos

integer

Outcome of AE (see Description)
Descripción

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

Tipo de datos

integer

Expected?
Descripción

Expected?

Tipo de datos

boolean

Serious Adverse Event
Descripción

Serious Adverse Event

Tipo de datos

text

Initials
Descripción

Initials

Tipo de datos

text

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Similar models

Adverse Events: CRF QMCR University of Alberta

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to Study Treatment
text
Relationship to Study Treatment
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
Serious Adverse Event
Code List
Serious Adverse Event
CL Item
Yes (complete SAE form) (1)
CL Item
No (2)
Initials
Item
Initials
text
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