Study Continuation

  1. StudyEvent: ODM
    1. Study Continuation
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Descrição

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 2?
Descrição

Study Continuation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrição

Reason for Non-Continuation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify SAE No.
Descrição

If SAE was main reason for non-continuation PLease complete and submit SAE report

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Please specify AE No. or solicited AE code.
Descrição

Please complete the Non-Serious Adverse Event section

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
UMLS CUI [2,3]
C1521902
Other, please specify
Descrição

e.g.: consent withdrawal, Protocol violation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Please tick who made the decision
Descrição

Responsible for Decision

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1273518
UMLS CUI [1,2]
C0679006

Similar models

Study Continuation

  1. StudyEvent: ODM
    1. Study Continuation
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Study Continuation
Item
Did the subject return for visit 2?
boolean
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Seroius Adverse event (SAE)
CL Item
Non-serious advese event (AEX)
CL Item
Other (OTH)
SAE No.
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event No.
Item
Please specify AE No. or solicited AE code.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Other Specification
Item
Other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Please tick who made the decision
text
C1273518 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)