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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
Subject Identifier
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
1. Date of visit/assessment
Description

Date below is the start of the study for this subject

Data type

date

Alias
UMLS CUI [1]
C1320303
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
C0220825
2. Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
3. Did the subject experience any non-serious adverse events during the study?
Description

Non-serious Adverse Event During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
4. Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
5. Were any repeat haematology or clinical chemistry samples taken?
Description

Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0870078
UMLS CUI [2,3]
C0205341
UMLS CUI [2,4]
C0347984
UMLS CUI [2,5]
C0008976
6. Were any repeat urinalysis samples taken?
Description

Urinalysis, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
7. Were any repeat ECGs perfonned?
Description

Electrocardiography, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0205341
8. Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Description

ECG abnormality, Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C1832603
UMLS CUI [1,2]
C2826293
9. Were any repeat vital signs recorded?
Description

Vital signs, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
10. Were any repeat PK blood samples taken?
Description

Pharmacokinetic aspects Sampling Repeat During Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
11. Were any repeat telemetry results taken?
Description

Telemetry, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0039451
UMLS CUI [1,2]
C0205341
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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)
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
1. Date of visit/assessment
date
C1320303 (UMLS CUI [1])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
Concomitant Agent During Clinical Trial
Item
2. Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Non-serious Adverse Event During Clinical Trial
Item
3. Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Serious Adverse Event
Item
4. Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Hematology finding or Clinical Chemistry Sampling Repeat During Clinical Trial
Item
5. Were any repeat haematology or clinical chemistry samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C0008976 (UMLS CUI [2,5])
Urinalysis, Sampling, Repeat
Item
6. Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Electrocardiography, Repeat
Item
7. Were any repeat ECGs perfonned?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
ECG abnormality, Clinical Significance
Item
8. Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C1832603 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Vital signs, Repeat
Item
9. Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects Sampling Repeat During Clinical Trial
Item
10. Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Telemetry, Repeat
Item
11. Were any repeat telemetry results taken?
boolean
C0039451 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
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