ID

16996

Beschrijving

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

Trefwoorden

  1. 19-08-16 19-08-16 -
Geüploaded op

19 augustus 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :


Geen commentaren

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Protocol Deviations Log: CRF QMCR University of Alberta

Protocol Deviations Log: CRF QMCR University of Alberta

General Information
Beschrijving

General Information

Study Name
Beschrijving

Study Name

Datatype

text

Site Number
Beschrijving

Site Number

Datatype

integer

Pt_ID
Beschrijving

Pt_ID

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

Did this participant have any protocol deviations?
Beschrijving

Did this participant have any protocol deviations?

Datatype

boolean

Protocol Deviations
Beschrijving

Protocol Deviations

Description of Protocol Deviation
Beschrijving

Description of Protocol Deviation

Datatype

text

Deviation Category (See Description)
Beschrijving

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

Datatype

text

Deviation Code
Beschrijving

Deviation Code

Datatype

integer

Date Deviation Occurred
Beschrijving

Date Deviation Occurred

Datatype

date

Date IRB Notified (if applicable)
Beschrijving

Date IRB Notified (if applicable)

Datatype

date

Principal Investigator´s Signature
Beschrijving

Principal Investigator´s Signature

Datatype

text

Date Signed
Beschrijving

Date Signed

Datatype

date

Similar models

Protocol Deviations Log: CRF QMCR University of Alberta

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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

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