ID

22593

Description

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 #: FVF4168g 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

Mots-clés

Versions (1)
  1. 08/06/2017 08/06/2017 -
Détendeur de droits

Genentech, Inc.

Téléchargé le

8 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

Anglais

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires  
Patient administration
Description

Patient administration

Subject Number
Description

PT

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials:
Description

PTINIT

Type de données

text

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

VDT

Type de données

date

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

SUBJECT ELIGIBILITY

Date Subject Signed Protocol Informed Consent:
Description

INFORM_CONSENT_DT

Type de données

date

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

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

Type de données

integer

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

Eligibility Criteria Not Met

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

CRIT_NOTMET

Type de données

text

Alias
UMLS CUI [1,1]
C1516637
Details
Description

DEVIATION_DETAILS

Type de données

text

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

APPROVAL

Type de données

boolean

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

APPROVAL_DT

Type de données

date

Alias
UMLS CUI [1,1]
C1707901
UMLS CUI [1,2]
C0011008
Retour au début de la page

Similar models

SUBJECT ELIGIBILITY (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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