ID

510

Description

AMC-046 Enrollment Form (ENR) Segment A Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BC16E2A-1509-2256-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BC16E2A-1509-2256-E044-0003BA3F9857

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 3/14/15 3/14/15 - Martin Dugas
Uploaded on

August 26, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Anal Cancer NCT00550589 Registration - AMC-046 Enrollment Form (ENR) Segment A - 2685912v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-046 Enrollment Form (ENR) Segment A
    1. No Instruction available.
Header Module
Description

Header Module

Principal Investigator
Description

PrincipalInvestigatorName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C19924
UMLS 2011AA ObjectClass
C1521895
Inclusion Criteria
Description

Inclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria046Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19707
UMLS 2011AA ObjectClass
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25532
UMLS 2011AA Property
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria046Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass
C19707
UMLS 2011AA ObjectClass
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property
C25370
UMLS 2011AA Property
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Age
Description

PatientAgeYearCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C29848
UMLS 2011AA ValueDomain
C0439234
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

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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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-046 Enrollment Form (ENR) Segment A
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
PrincipalInvestigatorName
Item
Principal Investigator
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C19924 (NCI Thesaurus ObjectClass)
C1521895 (UMLS 2011AA ObjectClass)
Item Group
Inclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property)
C1512693 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.1
Code List
Inclusion Criteria
CL Item
Date Of Informed Consent (Date of informed consent)
CL Item
Does The Investigator Believe That The Participant Is Capable Of Complying With The Protocol (Does the investigator believe that the participant is capable of complying with the protocol)
CL Item
Does The Participant Have A Life Expectancy >= 3 Months (Does the participant have a life expectancy >= 3 months)
CL Item
Does The Participant Have Documentation Of Hiv-1 Infection By Any Licensed Elisa Test Kit And Confirmed By Western Blot At Any Time Prior To Study Entry (Does the participant have documentation of HIV-1 infection by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry)
CL Item
Does The Participant Have The Ability And Willingness To Give Informed Consent (Does the participant have the ability and willingness to give informed consent)
CL Item
If Female, And Of Childbearing Potential, Has The Participant Had A Negative Urine Pregnancy Test Within The Past 7 Days (If female, and of childbearing potential, has the participant had a negative urine pregnancy test within the past 7 days)
CL Item
Participant's Age (in Years) (Participant's age (in years))
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass)
C1515830 (UMLS 2011AA ObjectClass)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property)
C0680251 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Exclusion Criteria
CL Item
Does The Participant Have Concurrent Neoplasia Requiring Cytotoxic Therapy (Does the participant have concurrent neoplasia requiring cytotoxic therapy)
CL Item
Does The Participant Have Untreated Invasive Cancer Of The Lower Genital Tract (Does the participant have untreated invasive cancer of the lower genital tract)
CL Item
Is The Participant Pregnant Or Breast-feeding (Is the participant pregnant or breast-feeding)
CL Item
Is The Participant Receiving Corticosteroid Treatment, Other Than Replacement Doses (Is the participant receiving corticosteroid treatment, other than replacement doses)
Item Group
Exclusion Criteria
PatientAgeYearCount
Item
Age
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C0439234 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item Group
Comments
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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