ID

37214

Beskrivning

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Nyckelord

Versioner (1)
  1. 2019-07-08 2019-07-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 juli 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Engelsk

CRF Tracking/Review Forms

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Beskrivning

Institution name, Identifier

Datatyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Investigator
Beskrivning

Investigator Name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
CRF Tracking/Review Form
Beskrivning

CRF Tracking/Review Form

Alias
UMLS CUI-1
C3889409
Module
Beskrivning

Clinical Trial Regulatory Tracking Document, Module

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1709061
Module Description
Beskrivning

Clinical Trial Regulatory Tracking Document, Module, Description

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1709061
UMLS CUI [1,3]
C0678257
Page Range
Beskrivning

Clinical Trial Regulatory Tracking Document, Page

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1704732
Modules
Beskrivning

Clinical Trial Regulatory Tracking Document, Module

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1709061
Missing pages (if applicable)
Beskrivning

Clinical Trial Regulatory Tracking Document, Page, Missing

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C1705492
Site Monitor’s comments (e.g. protocol violations or deviations)
Beskrivning

Clinical Trial Regulatory Tracking Document, Comment

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C0947611
Site Monitor’s signature
Beskrivning

Clinical Trial Regulatory Tracking Document, Investigator Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C2346576
Date Submitted
Beskrivning

Clinical Trial Regulatory Tracking Document, Submission, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1515022
UMLS CUI [1,3]
C0011008
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Similar models

CRF Tracking/Review Forms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Investigator Name
Item
Investigator
text
C2826892 (UMLS CUI [1])
Item Group
CRF Tracking/Review Form
C3889409 (UMLS CUI-1)
Item
Module
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Module
CL Item
MOD1 (1)
CL Item
MOD2 (2)
CL Item
MOD3 (3)
CL Item
MOD4 (4)
CL Item
MOD5 (5)
CL Item
MOD6 (6)
CL Item
MOD7 (7)
CL Item
MOD8 (8)
CL Item
MOD9 (9)
CL Item
MOD10 (10)
Item
Module Description
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Module
Code List
Module Description
CL Item
Screening/Course 1 (1)
CL Item
Course 2 (2)
CL Item
Course 3 (3)
CL Item
Course 4 (4)
CL Item
Course 5 (5)
CL Item
Course 6 (6)
CL Item
Course 7 (7)
CL Item
Course 8 (8)
CL Item
Course 9 (9)
CL Item
Course 10 (10)
Item
Page Range
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Page Range
CL Item
1-29 (1)
CL Item
30-45 (2)
CL Item
30-45 (3)
CL Item
30-45 (4)
CL Item
30-45 (5)
CL Item
30-45 (6)
CL Item
30-45 (7)
CL Item
30-45 (8)
CL Item
30-45 (9)
CL Item
30-45 (10)
Item
Modules
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Modules
CL Item
Sent to DM (1)
CL Item
Unused (2)
Clinical Trial Regulatory Tracking Document, Page, Missing
Item
Missing pages (if applicable)
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Comment
Item
Site Monitor’s comments (e.g. protocol violations or deviations)
text
C3889409 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Investigator Signature
Item
Site Monitor’s signature
text
C3889409 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Submission, Date in time
Item
Date Submitted
date
C3889409 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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