ID

13669

Beschrijving

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Trefwoorden

  1. 26-02-16 26-02-16 -
Geüploaded op

26 februari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Patient randomization form Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

CABACS Case Report Form [Patient randomization form]

Patient randomization form
Beschrijving

Patient randomization form

Patient ID
Beschrijving

Patient Study ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Are all inclusion criteria met?
Beschrijving

Verification of eligibility criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1711411
Have any exclusion criteria been answered with yes?
Beschrijving

Verification of eligibility criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1711411
Informed consent signed
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Date of informed consent
Beschrijving

Date of informed consent

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
Study site number
Beschrijving

Study site

Datatype

integer

Alias
UMLS CUI [1]
C2825164
Age
Beschrijving

Age

Datatype

text

Alias
UMLS CUI [1]
C0001779
Gender
Beschrijving

Gender

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Modified rankin scale score
Beschrijving

Modified rankin scale

Datatype

text

Alias
UMLS CUI [1]
C2984908
Please enter a phone number for further questions that might occur
Beschrijving

Phone contact

Datatype

integer

Alias
UMLS CUI [1]
C3476398
Please enter a valid fax number
Beschrijving

Fax number

Datatype

integer

Alias
UMLS CUI [1]
C1549619
Date of Randomization
Beschrijving

Date of Randomization

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Signature by investigator
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Beschrijving

Name of Investigator

Datatype

text

Alias
UMLS CUI [1]
C0008961
Patient has been randomized into following group
Beschrijving

Please send this form via FAX 049-201-92239-310 or 049-201-723-5933. Office time from 9AM until 4PM. You will receive the result of randomization within three hours if form is sent before 4PM. Otherwise the next morning. Shouldn´t you receive an answer after 3 hours, please give us a call. Anja Marr,Center for clinical trials in Essen, c/o Institute for medical informatics,biometrics and epidemiology, University Hospital Essen, Hufelandstraße 55, 45122 Essen,Germany

Datatype

text

Alias
UMLS CUI [1]
C0034656
Date of Randomization
Beschrijving

Date of Randomization

Datatype

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Signature by randomizing Person
Beschrijving

Signature

Datatype

text

Alias
UMLS CUI [1]
C1519316
Name of randomizing person
Beschrijving

Name

Datatype

text

Alias
UMLS CUI [1]
C0027365

Similar models

CABACS Case Report Form [Patient randomization form]

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Patient randomization form
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Verification of eligibility criteria
Item
Are all inclusion criteria met?
boolean
C1516637 (UMLS CUI [1,1])
C1711411 (UMLS CUI [1,2])
Verification of eligibility criteria
Item
Have any exclusion criteria been answered with yes?
boolean
C1516637 (UMLS CUI [1,1])
C1711411 (UMLS CUI [1,2])
Informed consent
Item
Informed consent signed
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Study site
Item
Study site number
integer
C2825164 (UMLS CUI [1])
Item
Age
text
C0001779 (UMLS CUI [1])
Code List
Age
CL Item
<60years (1)
CL Item
≥ 60 Jahre (2)
Item
Gender
integer
C0079399 (UMLS CUI [1])
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Modified rankin scale score
text
C2984908 (UMLS CUI [1])
Code List
Modified rankin scale score
CL Item
0-1 (1)
CL Item
2-3 (2)
Phone contact
Item
Please enter a phone number for further questions that might occur
integer
C3476398 (UMLS CUI [1])
Fax number
Item
Please enter a valid fax number
integer
C1549619 (UMLS CUI [1])
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
Item
Patient has been randomized into following group
text
C0034656 (UMLS CUI [1])
Code List
Patient has been randomized into following group
CL Item
CABG with CEA (1)
CL Item
CABG without CEA (2)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature
Item
Signature by randomizing Person
text
C1519316 (UMLS CUI [1])
Name
Item
Name of randomizing person
text
C0027365 (UMLS CUI [1])

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