Inglés

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

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

subject number

Tipo de datos

integer

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

Centre/Investigator Number

Tipo de datos

text

Screening failure
Descripción

Screening failure

Screening Failure (archive only)
Descripción

Screening Failure

Tipo de datos

boolean

CRF TRACKING/REVIEW FORM (TRF)
Descripción

CRF TRACKING/REVIEW FORM (TRF)

Module Description
Descripción

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

Tipo de datos

text

Sent to DPM
Descripción

Sent to DPM

Tipo de datos

boolean

Unused
Descripción

Unused module

Tipo de datos

boolean

Missing pages (if applicable)
Descripción

Missing pages

Tipo de datos

text

Comments and signature
Descripción

Comments and signature

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

comments

Tipo de datos

text

Site Monitor’s Name (Print clearly)
Descripción

Site Monitor’s Name

Tipo de datos

text

Site Monitor’s Signature
Descripción

Site Monitor’s Signature

Tipo de datos

text

Date Submitted
Descripción

Date Submitted

Tipo de datos

date

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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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