Follow-up studies, Study conclusion, Investigator's signature

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Visit type
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
Item
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
text
C0016441 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
C0016441 (UMLS CUI [2,1])
C0332158 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0016441 (UMLS CUI [3,1])
C0332158 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
Follow-up studies, Contact
Code List
If a booster study or a follow-up study is offered in the future, would the subject/parents/guardians be willing to be contacted and learn more about it?
CL Item
Yes (Y)
CL Item
No (N)
Item
If no contact desired, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0332158 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason for no contact
Code List
If no contact desired, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (1)
CL Item
Other (2)
Specification of reason
Item
Specification of reason
text
C0566251 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Study conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the subject experience any Serious Adverse Event during the study period?
text
C1519255 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
SAE durind study period
Code List
Did the subject experience any Serious Adverse Event during the study period?
CL Item
Yes (Y)
CL Item
No (N)
SAE Numbers
Item
If SAE, please specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item
Was the treatment blind broken during the study ?
text
C3897431 (UMLS CUI [1])
Treatment blind broken
Code List
Was the treatment blind broken during the study ?
CL Item
Yes (Y)
CL Item
No (N)
Treatment blind broken, date
Item
If treatment blind broken, complete date
date
C0011008 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
If treatment blind broken, tick one reason
integer
C0566251 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Treatment blind broken, reason
Code List
If treatment blind broken, tick one reason
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
Other reason for treatment blind broken
Item
If other reason for treatment blind broken, please specify
text
C3840932 (UMLS CUI [1,1])
C3897431 (UMLS CUI [1,2])
Item
Did any elimination criteria become applicable during the study ?
text
C0680251 (UMLS CUI [1])
Elimination criteria
Code List
Did any elimination criteria become applicable during the study ?
CL Item
No (N)
CL Item
Yes (Y)
Elimination criteria, specification
Item
If any elimination criteria became applicable, please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Was the subject withdrawn from the study ?
text
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Withdrawal of subject
Code List
Was the subject withdrawn from the study ?
CL Item
No (N)
CL Item
Yes (Y)
Item
If the subject was withdrawn, please tick the major reason for withdrawal
text
C1549995 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Withdrawal of subject, reason
Code List
If the subject was withdrawn, please 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
If you tick SAE as major reason for withdrawal, please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number/ solicited AE code
Item
If you tick AE as major reason for withdrawal, please specify AE Number OR solicited AE code
integer
C1518404 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Protocol violation, specification
Item
If you tick protocol violation as major reason for withdrawal, please specify
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Other reason for withdrawal, specification
Item
If you tick other as major reason for withdrawal, please specify
text
C3840932 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Who made the decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taken
Code List
Who made the decision?
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Subject's condition
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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