ID

16975

Descrizione

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.

collegamento

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

Keywords

  1. 17/08/16 17/08/16 -
Caricato su

17 agosto 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Adverse Events: CRF QMCR University of Alberta

Adverse Events: CRF QMCR University of Alberta

General Information
Descrizione

General Information

Study Name
Descrizione

Study Name

Tipo di dati

text

Site Number
Descrizione

Site Number

Tipo di dati

integer

Pt_ID
Descrizione

Pt_ID

Tipo di dati

integer

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

If yes, please list all Adverse Events below.

Tipo di dati

boolean

Adverse Events
Descrizione

Adverse Events

Adverse Event
Descrizione

Adverse Event

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

Stop Date
Descrizione

Stop Date

Tipo di dati

date

Severity
Descrizione

Severity

Tipo di dati

text

Relationship to Study Treatment
Descrizione

Relationship to Study Treatment

Tipo di dati

text

Action Taken (see Description)
Descrizione

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

Tipo di dati

integer

Outcome of AE (see Description)
Descrizione

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 di dati

integer

Expected?
Descrizione

Expected?

Tipo di dati

boolean

Serious Adverse Event
Descrizione

Serious Adverse Event

Tipo di dati

text

Initials
Descrizione

Initials

Tipo di dati

text

Similar models

Adverse Events: CRF QMCR University of Alberta

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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

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