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Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date/time of visit/assessment
Description

Date/time of visit/assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0545082
UMLS CUI [2,1]
C1264639
UMLS CUI [2,2]
C1516048
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Description

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-3
C2347852
UMLS CUI-5
C0205341
UMLS CUI-6
C0220825
Did the subject experience any non-serious adverse events during the study?
Description

non-serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

serious adverse events

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Were any concomitant medications taken by the subject during the study?
Description

concomitant medication

Data type

boolean

Alias
UMLS CUI [1]
C2347852
Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
Description

blood products

Data type

boolean

Alias
UMLS CUI [1]
C0456388
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0344211
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

abnormal, clinically significant ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2985739
Were any repeat ECGs performed?
Description

repeat ECGs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205341
Were any repeat haematology or clinical chemistry samples taken during the study?
Description

repeat haematology or clinical chemistry samples taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0018941
UMLS CUI [2,2]
C0200345
UMLS CUI [2,3]
C0205341
Were any repeat urinalysis samples taken?
Description

repeat urinalysis samples

Data type

boolean

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0042014
Were any repeat Blood pharmacodynamic samples taken for external analysis?
Description

repeat Blood pharmacodynamic samples taken for external analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C1277698
UMLS CUI [1,3]
C3844314
UMLS CUI [1,4]
C0851347
Were any repeat Urine pharmacodynamic samples taken for external analysis?
Description

repeat urine pharmacodynamic samples taken for external analysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200354
UMLS CUI [1,3]
C3844314
UMLS CUI [1,4]
C0851347
Were any repeat pharmocodynamic samples taken for analysis at site?
Description

repeat pharmocodynamic samples taken for analysis at site

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0851347
UMLS CUI [1,4]
C2825164
Were any repeat pharmacokinetic samples taken?
Description

repeat pharmacokinetic samples

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
Were any repeat vital signs recorded?
Description

repeat vital signs

Data type

boolean

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0518766
Liver Event
Description

Liver Event

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

If yes, please complete the Liver Event form(s).

Data type

boolean

Alias
UMLS CUI [1,1]
C0023901
UMLS CUI [1,2]
C0587081
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C2746065
UMLS CUI [1,5]
C0304229
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Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date/time of visit/assessment
Item
Date/time of visit/assessment
datetime
C1264639 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
concomitant medication
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
blood products
Item
Were any blood products / blood supportive care products taken by the subject between trauma and 48hrs after Day 3?
boolean
C0456388 (UMLS CUI [1])
C0456388 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
abnormal, clinically significant ECG
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
repeat ECGs
Item
Were any repeat ECGs performed?
boolean
C0013798 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken during the study?
boolean
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0018941 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
repeat urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0200345 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
repeat Blood pharmacodynamic samples taken for external analysis
Item
Were any repeat Blood pharmacodynamic samples taken for external analysis?
boolean
C0205341 (UMLS CUI [1,1])
C1277698 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
repeat urine pharmacodynamic samples taken for external analysis
Item
Were any repeat Urine pharmacodynamic samples taken for external analysis?
boolean
C0205341 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C3844314 (UMLS CUI [1,3])
C0851347 (UMLS CUI [1,4])
repeat pharmocodynamic samples taken for analysis at site
Item
Were any repeat pharmocodynamic samples taken for analysis at site?
boolean
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0851347 (UMLS CUI [1,3])
C2825164 (UMLS CUI [1,4])
repeat pharmacokinetic samples
Item
Were any repeat pharmacokinetic samples taken?
boolean
C0205341 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
repeat vital signs
Item
Were any repeat vital signs recorded?
boolean
C0205341 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item Group
Liver Event
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
liver chemistry results reached/exceeded investigational product stopping criteria
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023901 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
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