Inglese

Study/Core analysis conclusion

1 moduli  
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Descrizione

Workbook Number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Descrizione

Core Analysis 1: After 6 Months for WBs 2 and 4 and after 6 Months + 30 days for WBs 1 and 3. Core Analysis 2: After 12 Months for WBs 1 and 3 and after 12 Months + 30 days for WBs 2 and 4.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Occurrence of serious adverse event
Descrizione

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2745955
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
Descrizione

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C1519255
If SAE occurs during study, please specify total number of SAE's
Descrizione

Number of SAE

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Pregnancy information
Descrizione

Pregnancy information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant between vaccination and following visit?
Descrizione

If you tick yes, complete the pregnancy notification form. Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
Elimination criteria
Descrizione

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable between vaccination and following visit?
Descrizione

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18

Tipo di dati

text

Alias
UMLS CUI [1]
C0680251
If elimination criteria become applicable, please specify
Descrizione

Elimination criteria, specification

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348235
Withdraw from study
Descrizione

Withdraw from study

Alias
UMLS CUI-1
C2349954
UMLS CUI-2
C0008976
Was the subject withdrawn between vaccination and following visit?
Descrizione

Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18 "A subject is withdrawn from the CORE analysis 1/2 if he/she did not come for the CORE analysis 1/2 timepoint visit."

Tipo di dati

text

Alias
UMLS CUI [1]
C0422727
If subject was withdrawn, tick the major reason for withdrawal
Descrizione

(tick one box only). If you tick SAE, please complete and submit SAE report. If you tick AEX please complete Non-serious Adverse Event section.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0566251
SAE Number
Descrizione

Fill in if you ticked SAE as reason for withdrawal.

Tipo di dati

integer

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

Fill in if you ticked AE as reason for withdrawal.

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE code
Descrizione

Fill in if you ticked AE as reason for withdrawal.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0805701
Protocol violation, specification
Descrizione

Fill in if you ticked Protocol violation as reason for withdrawal.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
Other Reason for withdrawal
Descrizione

Fill in if you ticked other as reason for withdrawal.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C2348235
Who made the decision?
Descrizione

Decision maker

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
Date of last contact
Descrizione

day month year

Tipo di dati

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Descrizione

If you tick No, please give details in Adverse Events section.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1142435
Investigator's signature
Descrizione

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Descrizione

"I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below."

Tipo di dati

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator's name
Descrizione

Printed Investigator's name

Tipo di dati

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Descrizione

day month year

Tipo di dati

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Study/Core analysis conclusion

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB1 (1)
CL Item
WB2 (2)
CL Item
WB3 (3)
CL Item
WB4 (4)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Core Analysis 1 (1)
CL Item
Core Anaylsis 2 (2)
CL Item
End of study (all WBs) (3)
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
text
C2745955 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Occurrence of SAE
Code List
Did the subject experience any Serious Adverse Event between vaccination and the following visit?
CL Item
No (N)
CL Item
Yes (Y)
Number of SAE
Item
If SAE occurs during study, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Pregnancy information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant between vaccination and following visit?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Pregnancy during study
Code List
Did the subject become pregnant between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (not of childbearing potential or male) (NA)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Item
Did any elimination criteria become applicable between vaccination and following visit?
text
C0680251 (UMLS CUI [1])
Elimination criteria
Code List
Did any elimination criteria become applicable between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria, specification
Item
If elimination criteria become applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Withdraw from study
C2349954 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Was the subject withdrawn between vaccination and following visit?
text
C0422727 (UMLS CUI [1])
Subject's withdrawn
Code List
Was the subject withdrawn between vaccination and following visit?
CL Item
No (N)
CL Item
Yes (Y)
Item
If subject was withdrawn, tick the major reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for withdrawal
Code List
If subject was withdrawn, tick the major reason for withdrawal
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other (OTH)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE code
Item
Solicited AE code
text
C0877248 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Protocol violation, specification
Item
Protocol violation, specification
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other Reason for withdrawal
Item
Other Reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision maker
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Subject (S)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
text
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Subject's condition at last contact
Code List
Was the subject in good condition at date of last contact?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Printed Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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