ID

22640

Descripción

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 Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

Palabras clave

Versiones (1)
  1. 8/6/17 8/6/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

8 de junio de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

Inglés

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

1 formularios  
Patient administration
Descripción

Patient administration

Subject Number
Descripción

PT

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Descripción

PTINIT

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Report Date:
Descripción

VDT

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1302584
SUBJECT ELIGIBILITY
Descripción

SUBJECT ELIGIBILITY

Date Subject Signed Protocol Informed Consent:
Descripción

INFORM_CONSENT_DT

Tipo de datos

date

Alias
UMLS CUI [1]
C2985782
Did subject meet all eligibility criteria?
Descripción

If No: • Indicate the line number(s) (from worksheet) of eligibility criteria that was not met • Provide details of the deviation from the specified eligibility criteria • Indicate if waiver was given and the date granted

Tipo de datos

integer

Alias
UMLS CUI [1]
C1302261
Eligibility Criteria Not Met
Descripción

Eligibility Criteria Not Met

Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
Descripción

CRIT_NOTMET

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1516637
Details
Descripción

DEVIATION_DETAILS

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C0566251
Was A Waiver Granted?
Descripción

APPROVAL

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1707901
If Yes, Date:
Descripción

APPROVAL_DT

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1707901
UMLS CUI [1,2]
C0011008
Volver a la parte superior de la página

Similar models

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4170G Macular Edema NCT-Nummer: NCT00473382

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Patient administration
PT
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
PTINIT
Item
Subject Initials:
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
VDT
Item
Report Date:
date
C1302584 (UMLS CUI [1,1])
Item Group
SUBJECT ELIGIBILITY
INFORM_CONSENT_DT
Item
Date Subject Signed Protocol Informed Consent:
date
C2985782 (UMLS CUI [1])
Item
Did subject meet all eligibility criteria?
integer
C1302261 (UMLS CUI [1])
HAND_MOVEMENT_DESC [HDMVTD]
Code List
Did subject meet all eligibility criteria?
CL Item
With Direction (1)
CL Item
Without Direction (2)
Item Group
Eligibility Criteria Not Met
CRIT_NOTMET
Item
Line Number(s) of Eligibility Criteria Not Met (e.g., E-3)
text
C1516637 (UMLS CUI [1,1])
DEVIATION_DETAILS
Item
Details
text
C1555471 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
APPROVAL
Item
Was A Waiver Granted?
boolean
C1707901 (UMLS CUI [1,1])
APPROVAL_DT
Item
If Yes, Date:
date
C1707901 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial