ID

16277

Description

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

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

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

English

Protocol violation RICH study NCT02669589

1 forms  
Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
ID of Center
Description

Center ID

Data type

text

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

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Protocol violation
Description

Protocol violation

Alias
UMLS CUI-1
C1709750
Protocol violation:
Description

Protocol violation

Data type

text

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

Date of protocol violation

Data type

date

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

Description of Protocol Violation

Data type

text

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

Reason for Protocol Violation

Data type

text

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

Medical Procedure

Data type

text

Alias
UMLS CUI [1]
C0199171
Proven by:
Description

Proven by investigator

Data type

text

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

Proven date

Data type

date

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

Signature

Data type

text

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

Assessment of protocol violation

Data type

text

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

Identification and Signature

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

Date of report

Data type

date

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

Name of project manager

Data type

text

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

Signature of project manager

Data type

text

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

Protocol violation RICH study NCT02669589

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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