Engels

AE Follow-Up

1 Formulieren  
  1. StudyEvent: ODM
    1. AE Follow-Up
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Screening number
Beschrijving

Subject Screening No.

Datatype

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject no.
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
AE Follow-Up
Beschrijving

AE Follow-Up

Alias
UMLS CUI-1
C1522577
UMLS CUI-2
C0877248
Has the subject’s adverse events been reviewed?
Beschrijving

Adverse Events Reviewed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1709940
Does the subject have any ongoing adverse event at follow up?
Beschrijving

If yes, update adverse event source document and provide adverse event follow up letter

Datatype

boolean

Alias
UMLS CUI [1]
C2826663
AE letter given to subject?
Beschrijving

If no, provide reason If yes, provide date

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
Reason Letter Not Provided
Beschrijving

Reason Letter Not Provided

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C1272696
Date Letter Provided
Beschrijving

Date Letter Provided

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1096774
UMLS CUI [1,3]
C1999230
Conclusion
Beschrijving

Conclusion

Alias
UMLS CUI-1
C1707478
Clinical Staff initials
Beschrijving

Clinical Staff initials

Datatype

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0871685
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

AE Follow-Up

1 Formulieren
  1. StudyEvent: ODM
    1. AE Follow-Up
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Item Group
AE Follow-Up
C1522577 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Adverse Events Reviewed
Item
Has the subject’s adverse events been reviewed?
boolean
C0877248 (UMLS CUI [1,1])
C1709940 (UMLS CUI [1,2])
Adverse Event Ongoing
Item
Does the subject have any ongoing adverse event at follow up?
boolean
C2826663 (UMLS CUI [1])
AE letter Given to Subject
Item
AE letter given to subject?
boolean
C0877248 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
Reason Letter Not Provided
Item
Reason Letter Not Provided
text
C0877248 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C1272696 (UMLS CUI [1,5])
Date Letter Provided
Item
Date Letter Provided
date
C0011008 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
C1999230 (UMLS CUI [1,3])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Clinical Staff initials
Item
Clinical Staff initials
text
C2986440 (UMLS CUI [1,1])
C0871685 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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