Informatie:
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ID
16277
Beschrijving
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
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- 08-07-16 08-07-16 -
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8 juli 2016
DOI
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Creative Commons BY-NC-ND 3.0
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Protocol violation RICH study NCT02669589
Protocol violation RICH study NCT02669589
- StudyEvent: ODM
Similar models
Protocol violation RICH study NCT02669589
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Center ID
Item
ID of Center
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
ID of patient
text
C2348585 (UMLS CUI [1])
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])
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])
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])
C0392360 (UMLS CUI [1,2])
Medical Procedure
Item
Planned/ performed medical procedure
text
C0199171 (UMLS CUI [1])
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])
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])
C0220825 (UMLS CUI [1,2])
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)
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])
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])
C0681803 (UMLS CUI [1,2])