ID

27193

Beskrivning

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Nyckelord

Versioner (1)
  1. 2017-11-03 2017-11-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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CRF tracking/review form (TRF) Ropinirole CR Ropinirole IR Monotherapy 101468/168

Engelsk

CRF tracking/review form (TRF) Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Centre/Investigator Number
Beskrivning

Centre/Investigator Number

Datatyp

text

Screening failure
Beskrivning

Screening failure

Screening Failure (archive only)
Beskrivning

Screening Failure

Datatyp

boolean

CRF TRACKING/REVIEW FORM (TRF)
Beskrivning

CRF TRACKING/REVIEW FORM (TRF)

Module Description
Beskrivning

Module (e.g. MOD1); Module description (e.g. Screening – Week 12); Page range (e.g. 1 - 78)

Datatyp

text

Sent to DPM
Beskrivning

Sent to DPM

Datatyp

boolean

Unused
Beskrivning

Unused module

Datatyp

boolean

Missing pages (if applicable)
Beskrivning

Missing pages

Datatyp

text

Comments and signature
Beskrivning

Comments and signature

Site Monitor’s comments (eg. protocol violations or deviations)
Beskrivning

comments

Datatyp

text

Site Monitor’s Name (Print clearly)
Beskrivning

Site Monitor’s Name

Datatyp

text

Site Monitor’s Signature
Beskrivning

Site Monitor’s Signature

Datatyp

text

Date Submitted
Beskrivning

Date Submitted

Datatyp

date

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Similar models

CRF tracking/review form (TRF) Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Centre/Investigator Number
Item
Centre/Investigator Number
text
Item Group
Screening failure
Screening Failure
Item
Screening Failure (archive only)
boolean
Item Group
CRF TRACKING/REVIEW FORM (TRF)
Item
Module Description
text
Module Description
Code List
Module Description
CL Item
Screening – Week 12; 1 - 78 (MOD1)
CL Item
BDI (Baseline & Week 12), Epworth Sleepiness Scale (Baseline & Week 12); 301 - 312 (MOD2)
CL Item
Week 14 – Week 20; 79 - 102  (MOD3)
CL Item
BDI ( Week 20), Epworth Sleepiness Scale (Week 20); 313 - 318 (MOD4)
CL Item
Week 22 – Week 28; 103 - 120 (MOD5)
CL Item
BDI (Week 28), Epworth Sleepiness Scale (Week 28); 319 - 324 (MOD6)
CL Item
Week 30 – Week 36; 121 - 145 (MOD7)
CL Item
BDI (Week 36), Epworth Sleepiness Scale (Week 36); 325 - 330 (MOD8)
CL Item
Early Withdrawal, Follow-up (Week 38), Unscheduled dose changes (1-6), Concomitant medications, AEs, SAEs, Study Conclusion; 146 - 178 (MOD9)
CL Item
BDI (Early Withdrawal). Epworth Sleepiness Scale (Early Withdrawal); 331 - 336 (MOD10)
Sent to DPM
Item
Sent to DPM
boolean
Unused module
Item
Unused
boolean
Missing pages
Item
Missing pages (if applicable)
text
Item Group
Comments and signature
comments
Item
Site Monitor’s comments (eg. protocol violations or deviations)
text
Site Monitor’s Name
Item
Site Monitor’s Name (Print clearly)
text
Site Monitor’s Signature
Item
Site Monitor’s Signature
text
Date Submitted
Item
Date Submitted
date
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