0 Évaluations
ID

35804

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: requip Study Indication: Restless Legs Syndrome

Mots-clés

Versions (1)
  1. 2019-03-25 2019-03-25 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

25 mars 2019

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.

    Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

    Anglais

    CRF Tracking/Review Form (TRF)

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Centre Number
    Description

    Study Coordinating Center, Identification number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2825181 (Study Coordinating Center)
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Patient Number
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Patient Initials
    Description

    Person Initials

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Investigator
    Description

    Investigator Name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    CRF Tracking/Review Form
    Description

    CRF Tracking/Review Form

    Alias
    UMLS CUI-1
    C3889409 (Clinical Trial Regulatory Tracking Document)
    Screening Failure
    Description

    Trial Screening; failed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1710477 (Trial Screening)
    UMLS CUI [1,2]
    C0231175 (Failed)
    Module
    Description

    Module

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1709061 (Module)
    Module Description
    Description

    Module, Description

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1709061 (Module)
    UMLS CUI [1,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    Page Range
    Description

    Case Report Form, Page

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1516308 (Case Report Form)
    UMLS CUI [1,2]
    C1704732 (Page (document))
    Modules
    Description

    Module, Status

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1709061 (Module)
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Missing pages (if applicable)
    Description

    Case Report Form, Page, Missing

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1516308 (Case Report Form)
    UMLS CUI [1,2]
    C1704732 (Page (document))
    UMLS CUI [1,3]
    C1705492 (Missing)
    LOINC
    LA14698-7
    Site Monitor’s comments (eg. protocol violations or deviations)
    Description

    Case Report Form, Comment

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1516308 (Case Report Form)
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Signature
    Description

    Signature

    Alias
    UMLS CUI-1
    C1519316 (Signature)
    LOINC
    LP248948-4
    Site Monitor’s Name
    Description

    Medical Monitor, Name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1708968 (Medical Monitor)
    UMLS CUI [1,2]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Site Monitor’s Signature
    Description

    Medical Monitor, Signature

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1708968 (Medical Monitor)
    UMLS CUI [1,2]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Date Submitted
    Description

    Case Report Form, Submission, Date in time

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1516308 (Case Report Form)
    UMLS CUI [1,2]
    C1515022 (Submission)
    LOINC
    LP91032-0
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Retour au début de la page

    Similar models

    CRF Tracking/Review Form (TRF)

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Centre Number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator
    text
    C1320303 (UMLS CUI [1])
    Item Group
    CRF Tracking/Review Form
    C3889409 (UMLS CUI-1)
    Trial Screening; failed
    Item
    Screening Failure
    boolean
    C1710477 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Item
    Module
    text
    C1709061 (UMLS CUI [1])
    Module
    Code List
    Module
    CL Item
    MOD1  (1)
    CL Item
    MOD2  (2)
    CL Item
    MOD3  (3)
    CL Item
    MOD4  (4)
    CL Item
    MOD5  (5)
    CL Item
    SAE1&2  (6)
    CL Item
    FORMD1 (7)
    Item
    Module Description
    text
    C1709061 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Module, Description
    Code List
    Module Description
    CL Item
    Screening to Study Conc.  (1)
    CL Item
    RLS Rating Scales (2)
    CL Item
    Patient Scales (3)
    CL Item
    WPAI Wks 9 - 12 (4)
    CL Item
    Evening Vst Orthostatic Vitals  (5)
    CL Item
    Serious Adverse Experiences  (6)
    CL Item
    Form D (7)
    Item
    Page Range
    text
    C1516308 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    Case Report Form, Page
    Code List
    Page Range
    CL Item
    1-72  (1)
    CL Item
    79 - 117  (2)
    CL Item
    118 - 181  (3)
    CL Item
    182 - 189 (4)
    CL Item
    190 - 197  (5)
    CL Item
    73 - 76  (6)
    CL Item
    77 (7)
    Item
    Modules
    text
    C1709061 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Case Report Form, Page
    Code List
    Modules
    CL Item
    Sent to DM (1)
    CL Item
    Unused  (2)
    Case Report Form, Page, Missing
    Item
    Missing pages (if applicable)
    text
    C1516308 (UMLS CUI [1,1])
    C1704732 (UMLS CUI [1,2])
    C1705492 (UMLS CUI [1,3])
    Case Report Form, Comment
    Item
    Site Monitor’s comments (eg. protocol violations or deviations)
    text
    C1516308 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Signature
    C1519316 (UMLS CUI-1)
    Medical Monitor, Name
    Item
    Site Monitor’s Name
    text
    C1708968 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Medical Monitor, Signature
    Item
    Site Monitor’s Signature
    text
    C1708968 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Case Report Form, Submission, Date in time
    Item
    Date Submitted
    date
    C1516308 (UMLS CUI [1,1])
    C1515022 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Retour au début de la page 

    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