ID

22015

Description

Study part: Protocol exceptions. A phase III multinational, randomized, single-blind study of recombinant humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) in patients with HER2/neu overexpression who have not received prior cytotoxic chemotherapy for metastatic breast cancer. "Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche"

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Versions (1)
  1. 5/14/17 5/14/17 -
Copyright Holder

Roche

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May 14, 2017

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Creative Commons BY-NC 3.0
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PROTOCOL EXCEPTIONS Roche H0650g Breast Cancer

English

PROTOCOL EXCEPTIONS

1 forms  
  1. StudyEvent: ODM
    1. PROTOCOL EXCEPTIONS
PROTOCOL EXCEPTIONS
Description

PROTOCOL EXCEPTIONS

Alias
UMLS CUI-1
C1507394
PATIENT INT.
Description

Patient initial

Data type

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Description

Patient id

Data type

integer

Alias
UMLS CUI [1]
C2348585
DATE OF VISIT
Description

DATE OF VISIT

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0545082
1. DID THE PATIENT GET RANDOMIZED WITH PROTOCOL EXCEPTIONS?
Description

Randomization Protocol Document

Data type

boolean

Alias
UMLS CUI [1]
C3897777
2. IF YES. PLEASE INDICATE THE NUMBER(S) OF ELIGIBILITY CRITERIA FROM THE WORKSHEET WHICH WERE NOT SATISFIED AND PROVIDE A BRIEF DESCRIPTION OF EACH. PL.EASE ALSO SPECIFY THE NAME OF THE EMPLOYEE CONTACTED FOR APPROVAL AND THE DATE APPROVAL WAS OBTAINED
Description

2. IF YES. PLEASE INDICATE THE NUMBER(S) OF ELIGIBILITY CRITERIA FROM THE WORKSHEET WHICH WERE NOT SATISFIED AND PROVIDE A BRIEF DESCRIPTION OF EACH. PL.EASE ALSO SPECIFY THE NAME OF THE EMPLOYEE CONTACTED FOR APPROVAL AND THE DATE APPROVAL WAS OBTAINED

Eligibility Criteria
Description

Eligibility Criteria

Data type

text

Alias
UMLS CUI [1]
C1516637
BRIEF DESCRIPTION OF DEVIATION
Description

description Eligibility Criteria

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1516637
Clinical Contact
Description

investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
DATE OF CONTACT
Description

DATE OF CONTACT

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332158
SIGNATURE OF INVESTIGATOR (MD):
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

PROTOCOL EXCEPTIONS

1 forms
  1. StudyEvent: ODM
    1. PROTOCOL EXCEPTIONS
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PROTOCOL EXCEPTIONS
C1507394 (UMLS CUI-1)
Patient initial
Item
PATIENT INT.
text
C2986440 (UMLS CUI [1])
Patient id
Item
PATIENT NUMBER
integer
C2348585 (UMLS CUI [1])
DATE OF VISIT
Item
DATE OF VISIT
date
C0011008 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Randomization Protocol Document
Item
1. DID THE PATIENT GET RANDOMIZED WITH PROTOCOL EXCEPTIONS?
boolean
C3897777 (UMLS CUI [1])
Item Group
2. IF YES. PLEASE INDICATE THE NUMBER(S) OF ELIGIBILITY CRITERIA FROM THE WORKSHEET WHICH WERE NOT SATISFIED AND PROVIDE A BRIEF DESCRIPTION OF EACH. PL.EASE ALSO SPECIFY THE NAME OF THE EMPLOYEE CONTACTED FOR APPROVAL AND THE DATE APPROVAL WAS OBTAINED
Eligibility Criteria
Item
Eligibility Criteria
text
C1516637 (UMLS CUI [1])
description Eligibility Criteria
Item
BRIEF DESCRIPTION OF DEVIATION
text
C0678257 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
investigator name
Item
Clinical Contact
text
C2826892 (UMLS CUI [1])
DATE OF CONTACT
Item
DATE OF CONTACT
date
C0011008 (UMLS CUI [1,1])
C0332158 (UMLS CUI [1,2])
Investigator name
Item
SIGNATURE OF INVESTIGATOR (MD):
text
C2826892 (UMLS CUI [1])
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