Canadian Centres: When completed please mail to: National Cancer Institute of Canada, Clinical Trials Group, Queen's University, 82-84 Barrie Street, Kingston, Ontario, K7L 3N6

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Information
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
InvestigatorName
Item
Investigator Name
text
InstitutionName
Item
Institution Name
text
RegisteredInvestigator
Item
Registered Investigator (NCI Investigator #)
text
Item Group
Off Protocol Therapy
TreatmentEndDate
Item
Treatment End Date (yyyy mmm dd)
date
Item
Reason treatment ended (both components of study)
text
CL.1
Code List
Reason treatment ended (both components of study)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off treatment for other complicating disease)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Toxicity/side Effects/complications (Toxicity/side effects/complications)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Death On Study (Death on-study)
CL Item
Other, Specify (Other specify)
OffTreatmentReason,Other
Item
Other specify (Reason treatment ended)
text
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventCategory
Item
CTC Adverse Event Category
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade (Grade according to NCI Common Toxicity Criteria, Version 2.0)
text
Item
CTC Adverse Event Attribution Code
text
CL.2
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Item Group
Unblinding
TreatmentUnblindingIndicator
Item
Was study treatment unblinded?
boolean
TreatmentUnblindedDate
Item
Date study treatment unblinded (yyyy mmm dd)
text
Item Group
Header
PatientStudyID,CoordinatingGroup
Item
Patient Study ID, Coordinating Group
text
Patient Initials
Item
Patient Initials (first - middle - last)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item Group
Comments
Comments
Item
COMMENTS
text
Item Group
Investigator Signature
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
FormCompletionDate,Original
Item
Form Completion Date, Original (yyyy mmm dd)
date
Item Group
Ccrr Module For Off Treatment Form (opt)
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