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Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
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

Cohort

Data type

integer

Alias
UMLS CUI [1]
C0599755
Date of Assessment
Description

Date of Assessment

Data type

date

Alias
UMLS CUI [1]
C2985720
Type of Visit
Description

Type of Visit

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject experience any Serious Adverse Event during the study period ?
Description

If yes, please give the total number of SAE's in next item

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Total number of SAE's:
Description

if applicable

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did any elimination criteria become applicable during the study?
Description

If Yes, please specify in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2347804
UMLS CUI [1,3]
C0347984
Specify elimination criteria that became applicable during the study
Description

Specify elimination criteria during study

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
Was the subject withdrawn from study?
Description

If yes, fill in the remaining items in this itemgroup. If no, skip the rest of this itemgroup. Note for the interim analysis timepoint: A subject is withdrawn from the interim analysis if he/she did not come for the interim analysis timepoint visit.

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Major reason for withdrawal
Description

select one For SAE, Please complete and submit SAE report, and specify SAE No. For AEX/NSAE: Please complete Non-serious Adverse Event section, and please specify AE No. or solicited AE code for Protocol Violation, please specify For other, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205164
SAE Number
Description

also complete and submit SAE report

Data type

integer

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

also complete Non-serious Adverse Event form provide AE Number or solicited AE code (next item)

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE Code
Description

also complete Non-serious Adverse Event form provide AE Number or solicited AE code

Data type

text

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0600091
Specify protocol violation
Description

Specify protocol violation

Data type

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Specify other reason for withdrawal
Description

Specify other reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C1521902
Who made withdrawal decision?
Description

Who made withdrawal decision?

Data type

text

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

Date of last contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1705415
Was the subject in good condition at date of last contact?
Description

If no, please give details within the Adverse Events section

Data type

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0805839
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigators signature
Description

"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."

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigators signature Date
Description

Investigators signature Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2346576
Printed Investigator's name
Description

Investigator's name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
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)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Type of Visit
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
Interim Study Conclusion (at/after Visit 6) (1)
CL Item
Final Study Conclusion (at/after Visit 10) (2)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Total number of SAE's:
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Elimination criteria during the study
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1,1])
C2347804 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
Specify elimination criteria during study
Item
Specify elimination criteria that became applicable during the study
text
C2348235 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Was subject withdrawn from study?
Item
Was the subject withdrawn from study?
boolean
C0422727 (UMLS CUI [1])
Item
Major reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
reason for withdrawal
Code List
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
C1517001 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Specify protocol violation
Item
Specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Specify other reason for withdrawal
Item
Specify other reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
Item
Who made withdrawal decision?
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
reason for withdrawal
Code List
Who made withdrawal decision?
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1705415 (UMLS CUI [1,3])
Subject condition at last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigators signature Date
Item
Investigators signature Date
date
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator's name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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