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 Formulários

StudyEvent: AMC-061 Off Study Summary Form (F50)
1. 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.)

Ccrr Module For Off Study Summary - Rf50

Descrição

Ccrr Module For Off Study Summary - Rf50

Off Study Date (mm/dd/yyyy)

Descrição

Off-TreatmentStudyFollow-UpEndDate

Tipo de dados

date

Alias

NCI Thesaurus ValueDomain: C25164

UMLS 2011AA ValueDomain: C0011008

NCI Thesaurus ObjectClass: C25601

UMLS 2011AA ObjectClass: C1518544

NCI Thesaurus ObjectClass: C15206

UMLS 2011AA ObjectClass: C0008972

NCI Thesaurus Property: C25275

UMLS 2011AA Property: C2745955

Off Study Reason (select the primary reason)

Descrição

Off-TreatmentStudyFollow-UpReason

Tipo de dados

text

Alias

NCI Thesaurus ValueDomain: C25638

UMLS 2011AA ValueDomain: C0392360

NCI Thesaurus Property: C16033

UMLS 2011AA Property: C1522577

NCI Thesaurus ObjectClass: C25601

UMLS 2011AA ObjectClass: C1518544

NCI Thesaurus ObjectClass: C15206

UMLS 2011AA ObjectClass: C0008972

Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)

Lost To Follow-up (Patient lost to follow-up)

Patient Refused Follow-up (Patient refused follow-up)

Death (Death)

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

Other (Other)

Other, specify

Descrição

Off-TreatmentStudyFollow-UpSpecify

Tipo de dados

text

Alias

NCI Thesaurus ValueDomain: C25685

UMLS 2011AA ValueDomain: C1521902

NCI Thesaurus Property: C16033

UMLS 2011AA Property: C1522577

NCI Thesaurus ObjectClass: C25601

UMLS 2011AA ObjectClass: C1518544

NCI Thesaurus ObjectClass: C15206

UMLS 2011AA ObjectClass: C0008972

Comments

Descrição

ResearchCommentsText

Tipo de dados

text

Alias

NCI Thesaurus ValueDomain: C25704

UMLS 2011AA ValueDomain: C1527021

NCI Thesaurus ObjectClass: C15319

NCI Thesaurus Property: C25393

UMLS 2011AA Property: C0282411

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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 Formulários

StudyEvent: AMC-061 Off Study Summary Form (F50)
1. 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.)

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Off-Study Summary

Item Group

Ccrr Module For Off Study Summary - Rf50

Off-TreatmentStudyFollow-UpEndDate

Item

Off Study Date (mm/dd/yyyy)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

Off-TreatmentStudyFollow-UpReason

Item

Off Study Reason (select the primary reason)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)

CL.1

Code List

Off Study Reason (select the primary reason)

CL Item

Protocol-defined Follow-up Completed (Protocol-defined follow-up completed)

CL Item

Lost To Follow-up (Patient lost to follow-up)

CL310949 (NCI Metathesaurus)

CL Item

Patient Refused Follow-up (Patient refused follow-up)

CL Item

Death (Death)

C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)

CL Item

Adverse Event/side Effects/complications (Adverse Event/Side Effects/Complications)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Off-TreatmentStudyFollow-UpSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass)
C0008972 (UMLS 2011AA ObjectClass)

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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