Engels

Please submit this form if the subject has (at least one of the following): 1) completed the post treatment follow-up period per protocol 2) been lost to follow-up 3) has refused follow-up 4) withdrew consent 5) has died. (Note: If all follow-up for a subject has been completed, all subjects (except those never initiating protocol therapy) must have both an Off Protocol Treatment Summary form and Off Study Summary form submitted.)

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Off-Study Summary
Beschrijving

Off-Study Summary

Alias
UMLS CUI-1
C1518546
UMLS CUI-2
C1706244
Off Study Date
Beschrijving

Off-Treatment Study Follow-Up Date

Datatype

date

Maateenheden
  • mm/dd/yyyy
Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
NCI Thesaurus Property
C25275
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0011008
mm/dd/yyyy
Off Study Reason (select the primary reason)
Beschrijving

Off Study Reason

Datatype

integer

Alias
NCI Thesaurus ValueDomain
C25638
NCI Thesaurus Property
C16033
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
Other, specify
Beschrijving

Off-Treatment Follow-Up

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus Property
C16033
NCI Thesaurus ObjectClass
C25601
NCI Thesaurus ObjectClass-2
C15206
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C1521902
Comments
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS CUI [1]
C0947611
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Similar models

Please submit this form if the subject has (at least one of the following): 1) completed the post treatment follow-up period per protocol 2) been lost to follow-up 3) has refused follow-up 4) withdrew consent 5) has died. (Note: If all follow-up for a subject has been completed, all subjects (except those never initiating protocol therapy) must have both an Off Protocol Treatment Summary form and Off Study Summary form submitted.)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Off-Study Summary
C1518546 (UMLS CUI-1)
C1706244 (UMLS CUI-2)
Off-Treatment Study Follow-Up Date
Item
Off Study Date
date
C25164 (NCI Thesaurus ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)
C1518544 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Off Study Reason (select the primary reason)
integer
C25638 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
CL.1
Code List
Off Study Reason (select the primary reason)
CL Item
Protocol-defined Follow-up Completed (1)
C1522577 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
CL Item
Patient lost to follow-up (2)
C2348579 (UMLS CUI-1)
CL Item
Patient refused follow-up (3)
C0580699 (UMLS CUI-1)
CL Item
Death (4)
C0011065 (UMLS CUI-1)
CL Item
Adverse Event/Side Effects/Complications (5)
C0877248 (UMLS CUI-1)
CL Item
Other (6)
C0205394 (UMLS CUI-1)
Off-Treatment Follow-Up
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C16033 (NCI Thesaurus Property)
C25601 (NCI Thesaurus ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C1518544 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0947611 (UMLS CUI [1])
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