ID

16779

Description

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

Link

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

Keywords

Versions (1)
  1. 8/7/16 8/7/16 -
Uploaded on

August 7, 2016

DOI

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License

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

English

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

1 forms  
Header
Description

Header

Screening number
Description

screening number

Data type

integer

Alias
UMLS CUI [1]
C1710477
Site Contact
Description

Site Contact

Investigator Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Form Completed by
Description

Person Completing Form

Data type

text

Alias
UMLS CUI [1]
C1550483
Date
Description

Form Completion Date

Data type

date

Alias
UMLS CUI [1]
C1549507
Telephone number
Description

Telephone number

Data type

integer

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

Fax number

Data type

integer

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

Waiver Request

Waiver request information
Description

Waiver request

Data type

integer

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

Screening Eligibility Waiver

Data type

text

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

Screening Eligibility Waiver

Data type

integer

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

Reason for waiver request

Data type

text

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

Covance Review

Clinical Name (please print)
Description

Clinical Name

Data type

text

Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1]
C0807937
OSI Review
Description

OSI Review

Clinical Name (please print)
Description

Clinical Name

Data type

text

Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1]
C0807937
Waiver Request
Description

Waiver Request

Data type

integer

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

Reason for denial of waiver request

Data type

text

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

For OSI Use Only

Attention (please print)
Description

Attention

Data type

text

Faxed by (please print)
Description

Faxed by

Data type

text

Date
Description

Date

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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