ID

16705

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 of Study: Deviation Log

Link

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

Keywords

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

August 1, 2016

DOI

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License

Creative Commons BY 4.0
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Deviation Log, Tarceva in NSCLC patients who have EGFR-positive tumors DRKS00001485 NCT00373425

English

Deviation Log, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms  
Deviation Log
Description

Deviation Log

Visit Name
Description

Visit Name

Data type

text

Alias
UMLS CUI [1]
C2826704
CRF Page Number (if applicable)
Description

CRF Page Number

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C1704732
Description
Description

Description of Deviation

Data type

text

Alias
UMLS CUI [1]
C1705236
Site Personnel Initials
Description

Site Personnel Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C2985654
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Type: preapproved
Description

Deviation Type

Data type

boolean

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0332307
Type
Description

Deviation Type

Data type

integer

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0332307
Signature
Description

Signature

Alias
UMLS CUI-1
C1519316
Monitor Name
Description

Monitor Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1521743
Monitor signature
Description

Monitor Signature

Data type

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521743
Signature Date
Description

Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0011008
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Similar models

Deviation Log, Tarceva in NSCLC patients who have EGFR-positive tumors NCT00373425

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Deviation Log
Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
CRF Page Number
Item
CRF Page Number (if applicable)
integer
C1516308 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Description of Deviation
Item
Description
text
C1705236 (UMLS CUI [1])
Site Personnel Initials
Item
Site Personnel Initials
text
C2986440 (UMLS CUI [1,1])
C2985654 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Deviation Type
Item
Type: preapproved
boolean
C1705236 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item
Type
integer
C1705236 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Deviation Type
Code List
Type
CL Item
01 Not Done (1)
CL Item
02 Outside of Window (2)
CL Item
03 Excluded Prior Therapy (3)
CL Item
04 Excluded Concomitant Medication (4)
CL Item
05 Value Out of Range (5)
CL Item
06 Same Method Not Used (6)
CL Item
07 lncorrect Dose (7)
CL Item
08 Dose Not Held (8)
CL Item
09 Dose Not Reduced (9)
CL Item
10 Dose Not Escalated (10)
CL Item
11 lncorrectly Assigned or Stratified (11)
CL Item
12 Other - Use Only As A Last Resort (12)
Item Group
Signature
C1519316 (UMLS CUI-1)
Monitor Name
Item
Monitor Name
text
C0027365 (UMLS CUI [1,1])
C1521743 (UMLS CUI [1,2])
Monitor Signature
Item
Monitor signature
text
C1519316 (UMLS CUI [1,1])
C1521743 (UMLS CUI [1,2])
Signature Date
Item
Signature Date
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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