ID

22015

Beskrivning

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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Versioner (1)
  1. 2017-05-14 2017-05-14 -
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Roche

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14 maj 2017

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

Engelsk

PROTOCOL EXCEPTIONS

1 Formulär  
  1. StudyEvent: ODM
    1. PROTOCOL EXCEPTIONS
PROTOCOL EXCEPTIONS
Beskrivning

PROTOCOL EXCEPTIONS

Alias
UMLS CUI-1
C1507394
PATIENT INT.
Beskrivning

Patient initial

Datatyp

text

Alias
UMLS CUI [1]
C2986440
PATIENT NUMBER
Beskrivning

Patient id

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
DATE OF VISIT
Beskrivning

DATE OF VISIT

Datatyp

date

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

Randomization Protocol Document

Datatyp

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
Beskrivning

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
Beskrivning

Eligibility Criteria

Datatyp

text

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

description Eligibility Criteria

Datatyp

text

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

investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
DATE OF CONTACT
Beskrivning

DATE OF CONTACT

Datatyp

date

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

PROTOCOL EXCEPTIONS

1 Formulär
  1. StudyEvent: ODM
    1. PROTOCOL EXCEPTIONS
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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