Englisch

Extended safety follow-up contact

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C0011298
Center number
Beschreibung

Center number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Study conclusion extended safety follow-up contact
Beschreibung

Study conclusion extended safety follow-up contact

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C1522577
Could the subject's parents/guardians be contacted after the end of the active phase?
Beschreibung

Contact after active phase with parent/legal guardian

Datentyp

text

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0030551
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0008976
UMLS CUI [2,1]
C0332158
UMLS CUI [2,2]
C1274041
UMLS CUI [2,3]
C0332282
UMLS CUI [2,4]
C0008976
If contact, note the Date of last contact
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0805839
If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
Beschreibung

If you tick yes: GlaxoSmithKline might contact you for further investigation

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1517586
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205394
If no contact, give reason
Beschreibung

Reason for no contact

Datentyp

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0332158
UMLS CUI [1,3]
C0030551
UMLS CUI [1,4]
C0566251
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0332158
UMLS CUI [2,3]
C1274041
UMLS CUI [2,4]
C0566251
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
Beschreibung

IF you tick yes, please complete the complete Serious Adverse Event (SAE) report

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0008976
Has the subject experienced any meningitis ?
Beschreibung

If you tick yes, please complete an SAE form and the meningitis page.

Datentyp

text

Alias
UMLS CUI [1]
C0025289
Investigator's Signature
Beschreibung

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

I confirm that I have reviewed the Extended Safety Follow-Up 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.

Datentyp

text

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

Printed Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Extended safety follow-up contact

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Demographics
C0011298 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item Group
Study conclusion extended safety follow-up contact
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
Item
Could the subject's parents/guardians be contacted after the end of the active phase?
text
C0332158 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0332158 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
C0332282 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Contact after active phase
Code List
Could the subject's parents/guardians be contacted after the end of the active phase?
CL Item
Yes (Y)
CL Item
No (N)
Date of last contact
Item
If contact, note the Date of last contact
date
C0805839 (UMLS CUI [1])
Item
If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
text
C2368628 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Administration of investigational vaccine
Code List
If contact: Has the subject received any other investigational and/or non-registered vaccine and/or drug since the end of the active phase?
CL Item
No (N)
CL Item
Yes (Y)
Item
If no contact, give reason
text
C1298908 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0030551 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1298908 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C1274041 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])
Reason for no contact
Code List
If no contact, give reason
CL Item
Consent withdrawal (CWS)
CL Item
Lost to follow-up (LFU)
Item
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
SAE
Code List
Did the subject experience any serious adverse event(s) (SAE(s) since the end of the active phase?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Subject could not be contacted (NA)
Item
Has the subject experienced any meningitis ?
text
C0025289 (UMLS CUI [1])
Meningitis after active phase
Code List
Has the subject experienced any meningitis ?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Subject could not be contacted (NA)
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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