ID

16277

Descripción

NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

Palabras clave

Versiones (1)
  1. 8/7/16 8/7/16 -
Subido en

8 de julio de 2016

DOI

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Licencia

Creative Commons BY-NC-ND 3.0
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Protocol violation RICH study NCT02669589

Inglés

Protocol violation RICH study NCT02669589

1 formularios  
Patient Information
Descripción

Patient Information

Alias
UMLS CUI-1
C1955348
ID of Center
Descripción

Center ID

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
ID of patient
Descripción

Patient ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Protocol violation
Descripción

Protocol violation

Alias
UMLS CUI-1
C1709750
Protocol violation:
Descripción

Protocol violation

Tipo de datos

text

Alias
UMLS CUI [1]
C1709750
Date of protocol violation
Descripción

Date of protocol violation

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1709750
Description of Protocol Violation
Descripción

Description of Protocol Violation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0678257
Reason for Protocol Violation
Descripción

Reason for Protocol Violation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0392360
Planned/ performed medical procedure
Descripción

Medical Procedure

Tipo de datos

text

Alias
UMLS CUI [1]
C0199171
Proven by:
Descripción

Proven by investigator

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0456369
UMLS CUI [1,2]
C2826892
Proven: Date
Descripción

Proven date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0456369
UMLS CUI [1,2]
C0011008
Signature of examiner/ authorized medical personal
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Assessment of protocol violation: (evaluation should be performed after consultation with biometrics and/or LKP)
Descripción

Assessment of protocol violation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C0220825
Identification and Signature
Descripción

Identification and Signature

Alias
UMLS CUI-1
C0205396
UMLS CUI-2
C1519316
Date of report
Descripción

Date of report

Tipo de datos

date

Alias
UMLS CUI [1]
C1302584
Name of project manager
Descripción

Name of project manager

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0681803
Signature of project manager
Descripción

Signature of project manager

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0681803
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Similar models

Protocol violation RICH study NCT02669589

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of patient
text
C2348585 (UMLS CUI [1])
Item Group
Protocol violation
C1709750 (UMLS CUI-1)
Item
Protocol violation:
text
C1709750 (UMLS CUI [1])
Protocol violation
Code List
Protocol violation:
CL Item
Inclusion/Exclusion criteria (1)
CL Item
Therapy process/ trial process (2)
CL Item
test product (3)
CL Item
Information given by not authorized medical personal (4)
CL Item
Other problems with informed consent (5)
CL Item
Others (6)
Date of protocol violation
Item
Date of protocol violation
date
C0011008 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
Description of Protocol Violation
Item
Description of Protocol Violation
text
C1709750 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Reason for Protocol Violation
Item
Reason for Protocol Violation
text
C1709750 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Medical Procedure
Item
Planned/ performed medical procedure
text
C0199171 (UMLS CUI [1])
Item
Proven by:
text
C0456369 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
Proven by investigator
Code List
Proven by:
CL Item
examiner (1)
CL Item
ward physician (2)
CL Item
authorized medical personal (7)
Proven date
Item
Proven: Date
date
C0456369 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature
Item
Signature of examiner/ authorized medical personal
text
C1519316 (UMLS CUI [1])
Item
Assessment of protocol violation: (evaluation should be performed after consultation with biometrics and/or LKP)
text
C1709750 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Assessment of protocol violation
Code List
Assessment of protocol violation: (evaluation should be performed after consultation with biometrics and/or LKP)
CL Item
Major (Major)
CL Item
Minor (Minor)
Item Group
Identification and Signature
C0205396 (UMLS CUI-1)
C1519316 (UMLS CUI-2)
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Name of project manager
Item
Name of project manager
text
C0027365 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
Signature of project manager
Item
Signature of project manager
text
C1519316 (UMLS CUI [1,1])
C0681803 (UMLS CUI [1,2])
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