ID

37756

Beschreibung

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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Versionen (1)
  1. 22.08.19 22.08.19 -
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GlaxoSmithKline

Hochgeladen am

22. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Englisch

CRF Tracking/Review Forms

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Investigator
Beschreibung

Investigator Name

Datentyp

text

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

CRF Tracking/Review Form

Alias
UMLS CUI-1
C3889409
Screening failure (archive only)
Beschreibung

Clinical Trial Regulatory Tracking Document, Trial Screening, Failed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1710477
UMLS CUI [1,3]
C0231175
Module
Beschreibung

Clinical Trial Regulatory Tracking Document, Module

Datentyp

text

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

Clinical Trial Regulatory Tracking Document, Module, Description

Datentyp

text

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

Clinical Trial Regulatory Tracking Document, Page, Range

Datentyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1704732
UMLS CUI [1,3]
C1514721
Modules
Beschreibung

Clinical Trial Regulatory Tracking Document, Module, Send

Datentyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C1709061
UMLS CUI [1,3]
C1519246
Missing pages (if applicable)
Beschreibung

Clinical Trial Regulatory Tracking Document, Page, Missing

Datentyp

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)
Beschreibung

Clinical Trial Regulatory Tracking Document, Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C0947611
Site Monitor's signature
Beschreibung

Clinical Trial Regulatory Tracking Document, Investigator Signature

Datentyp

text

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

Clinical Trial Regulatory Tracking Document, Investigator Signature, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C3889409
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
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Ähnliche Modelle

CRF Tracking/Review Forms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (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)
Clinical Trial Regulatory Tracking Document, Trial Screening, Failed
Item
Screening failure (archive only)
boolean
C3889409 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
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
SAE1 (2)
CL Item
SAE2 (3)
CL Item
SAE3 (4)
CL Item
SAE4 (5)
CL Item
SAE5 (6)
CL Item
FORMD (7)
CL Item
PSFM1 (8)
CL Item
PSFM2 (9)
CL Item
PSFM3 (10)
CL Item
PSFM4 (11)
CL Item
PSFM5 (12)
CL Item
PSFM6 (13)
CL Item
PSFM7 (14)
CL Item
PSFM8 (15)
CL Item
PSFU1 (16)
CL Item
PSFU2 (17)
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
Serious Adverse Experiences (2)
CL Item
Serious Adverse Experiences (3)
CL Item
Serious Adverse Experiences (4)
CL Item
Serious Adverse Experiences (5)
CL Item
Serious Adverse Experiences (6)
CL Item
Form D (7)
CL Item
Post-Study Minimal FU M3 (8)
CL Item
Post-Study Minimal FU M6 (9)
CL Item
Post-Study Minimal FU M9 (10)
CL Item
Post-Study Minimal FU M12 (11)
CL Item
Post-Study Minimal FU M15 (12)
CL Item
Post-Study Minimal FU M18 (13)
CL Item
Post-Study Minimal FU M21 (14)
CL Item
Post-Study Minimal FU M324 (15)
CL Item
Post-Study Minimal FU M___ (16)
CL Item
Post-Study Minimal FU M___ (17)
Item
Page Range
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Module
Code List
Page Range
CL Item
1-25 (1)
CL Item
26-27 (2)
CL Item
28-29 (3)
CL Item
30-31 (4)
CL Item
32-33 (5)
CL Item
34-35 (6)
CL Item
36 (7)
CL Item
1 page (8)
CL Item
1 page (9)
CL Item
1 page (10)
CL Item
1 page (11)
CL Item
1 page (12)
CL Item
1 page (13)
CL Item
1 page (14)
CL Item
1 page (15)
CL Item
1 page (16)
CL Item
1 page (17)
Item
Modules
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Module, Send
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, Investigator Signature, Date in time
Item
Date Submitted
date
C3889409 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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