Inglés

Check for study continuation

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit type
Descripción

Visit type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit date
Descripción

day month year REMINDER: If Screening Visit and Visit «Day 0» were done at the same day, please fill in Visit «Day 0» with the same date of visit.

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Check for study continuation
Descripción

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for this visit?
Descripción

Continuation status

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If subject did not return to visit, please tick the ONE most appropriate reason.
Descripción

If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0566251
If you ticked SAE as primary reason for no continuation, please specify SAE Number
Descripción

SAE Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If you ticked AE as primary reason for no continuation, please specify AE Number
Descripción

AE Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
If you ticked other reason as primary reason for no continuation, please specify
Descripción

(e.g.: consent withdrawal, Protocol violation, …)

Tipo de datos

text

Alias
UMLS CUI [1]
C3840932
Please tick who made the decision
Descripción

Decision taken

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Volver a la parte superior de la página

Similar models

Check for study continuation

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6  (6)
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Did the subject return for this visit?
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Continuation status
Code List
Did the subject return for this visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject did not return to visit, please tick the ONE most appropriate reason.
text
C1298908 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Reason for no continuation
Code List
If subject did not return to visit, please tick the ONE most appropriate reason.
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
If you ticked SAE as primary reason for no continuation, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
If you ticked AE as primary reason for no continuation, please specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason
Item
If you ticked other reason as primary reason for no continuation, please specify
text
C3840932 (UMLS CUI [1])
Item
Please tick who made the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taken
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)
Volver a la parte superior de la página