ID

16779

Beskrivning

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc (OSI Pharmaceuticals) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Part: Protocol Waiver Approval

Länk

https://clinicaltrials.gov/ct2/show/NCT00373425

Nyckelord

Versioner (1)
  1. 2016-08-07 2016-08-07 -
Uppladdad den

7 augusti 2016

DOI

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Licens

Creative Commons BY 4.0
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Protocol Waiver Approval, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

Engelsk

Protocol Waiver Approval, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 Formulär  
Header
Beskrivning

Header

Screening number
Beskrivning

screening number

Datatyp

integer

Alias
UMLS CUI [1]
C1710477
Site Contact
Beskrivning

Site Contact

Investigator Name
Beskrivning

Investigator Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Form Completed by
Beskrivning

Person Completing Form

Datatyp

text

Alias
UMLS CUI [1]
C1550483
Date
Beskrivning

Form Completion Date

Datatyp

date

Alias
UMLS CUI [1]
C1549507
Telephone number
Beskrivning

Telephone number

Datatyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus Property
C25395
NCI Thesaurus ObjectClass
C19711
UMLS CUI [1]
C1515258
Fax number
Beskrivning

Fax number

Datatyp

integer

Alias
NCI Thesaurus ValueDomain
C25704
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C42775
UMLS CUI [1]
C1549619
Waiver Request
Beskrivning

Waiver Request

Waiver request information
Beskrivning

Waiver request

Datatyp

integer

Alias
UMLS CUI [1]
C2699053
If screening eligibility: Criterion Letter(s):
Beskrivning

Screening Eligibility Waiver

Datatyp

text

Alias
UMLS CUI [1]
C1707901
If treatment eligibility: Criterion Number(s):
Beskrivning

Screening Eligibility Waiver

Datatyp

integer

Alias
UMLS CUI [1]
C1707901
Reason for waiver request
Beskrivning

Reason for waiver request

Datatyp

text

Alias
UMLS CUI [1,1]
C2699053
UMLS CUI [1,2]
C0392360
Covance Review
Beskrivning

Covance Review

Clinical Name (please print)
Beskrivning

Clinical Name

Datatyp

text

Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Date
Beskrivning

Signature Date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
OSI Review
Beskrivning

OSI Review

Clinical Name (please print)
Beskrivning

Clinical Name

Datatyp

text

Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1]
C1519316
Date
Beskrivning

Signature Date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Waiver Request
Beskrivning

Waiver Request

Datatyp

integer

Alias
UMLS CUI [1]
C2699053
If request denied, specify reason:
Beskrivning

Reason for denial of waiver request

Datatyp

text

Alias
UMLS CUI [1,1]
C2699053
UMLS CUI [1,2]
C3274861
For OSI Use Only
Beskrivning

For OSI Use Only

Attention (please print)
Beskrivning

Attention

Datatyp

text

Faxed by (please print)
Beskrivning

Faxed by

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Protocol Waiver Approval, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
screening number
Item
Screening number
integer
C1710477 (UMLS CUI [1])
Item Group
Site Contact
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Person Completing Form
Item
Form Completed by
text
C1550483 (UMLS CUI [1])
Form Completion Date
Item
Date
date
C1549507 (UMLS CUI [1])
Telephone number
Item
Telephone number
integer
C25337 (NCI Thesaurus ValueDomain)
C25395 (NCI Thesaurus Property)
C19711 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI [1])
Fax number
Item
Fax number
integer
C25704 (NCI Thesaurus ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C42775 (NCI Thesaurus Property)
C1549619 (UMLS CUI [1])
Item Group
Waiver Request
Item
Waiver request information
integer
C2699053 (UMLS CUI [1])
Waiver request
Code List
Waiver request information
CL Item
Screening Eligibility (1)
CL Item
Treatment Eligibility (2)
Screening Eligibility Waiver
Item
If screening eligibility: Criterion Letter(s):
text
C1707901 (UMLS CUI [1])
Screening Eligibility Waiver
Item
If treatment eligibility: Criterion Number(s):
integer
C1707901 (UMLS CUI [1])
Reason for waiver request
Item
Reason for waiver request
text
C2699053 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Covance Review
Clinical Name
Item
Clinical Name (please print)
text
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Item Group
OSI Review
Clinical Name
Item
Clinical Name (please print)
text
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Item
Waiver Request
integer
C2699053 (UMLS CUI [1])
Eligibility Waiver
Code List
Waiver Request
CL Item
Request approved (1)
CL Item
Request denied (specify reason) (2)
Reason for denial of waiver request
Item
If request denied, specify reason:
text
C2699053 (UMLS CUI [1,1])
C3274861 (UMLS CUI [1,2])
Item Group
For OSI Use Only
Attention
Item
Attention (please print)
text
Faxed by
Item
Faxed by (please print)
text
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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