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Study Continuation Visit 1

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

To be used for these two cohorts only.

Data type

integer

Alias
UMLS CUI [1]
C0599755
Date of Visit
Description

Visit 1 is scheduled at 6-10 weeks of life.

Data type

date

Alias
UMLS CUI [1]
C1320303
Study Continuation
Description

Study Continuation

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

If yes, complete the appropriate forms. If no, please select the ONE most appropriate reason and skip the following forms of this visit.

Data type

boolean

Alias
UMLS CUI [1]
C0805733
reason for study non-continuation
Description

If SAE, please complete and submit SAE report, and specify SAE No. If AE, please complete Non-serious Adverse Event form, and specify AE No. If Other Reason, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Specify SAE Number
Description

if SAE major reason for non-continuation

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Specify AE Number
Description

if AE major reason for non-continuation

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify other reason for non-continuation
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C2348235
UMLS CUI [1,3]
C0457454
UMLS CUI [1,4]
C0008976
Please select who made the decision
Description

Who made discontinuation decision

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
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Similar models

Study Continuation Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Returned for this visit?
Item
Did the subject return for this visit?
boolean
C0805733 (UMLS CUI [1])
Item
reason for study non-continuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
major reason for vaccine non-administration
Code List
reason for study non-continuation
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
Specify SAE Number
Item
Specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify AE Number
Item
Specify AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify other reason for study discontinuation
Item
Specify other reason for non-continuation
text
C3840932 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0457454 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Item
Please select who made the decision
text
C0457454 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Who made non-administration decision
Code List
Please select who made the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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