ID

29055

Description

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Mots-clés

Versions (5)
  1. 05/10/2017 05/10/2017 -
  2. 22/02/2018 22/02/2018 -
  3. 22/02/2018 22/02/2018 -
  4. 22/02/2018 22/02/2018 -
  5. 17/09/2021 17/09/2021 -
Détendeur de droits

gsk

Téléchargé le

22 février 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Ropinirole Case Report Form GSK RRL100013

Anglais

CONCOMITANT MEDICATIONS

9 Formulaires  
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

MONITOR DATA VALIDATION CHECKS
Description

Check that either 'Yes' or 'No' box at the top of the page has been completed. Ensure that the spelling of the Drug Name(s) is correct (use of Trade Names is preferred). Check that either medication start date is completed or 'Taken Prior to Study?' is 'Yes'. It is acceptable for start date to be missing if 'Taken Prior to Study?' is 'Yes'. It is acceptable if 'Taken Prior to Study?' is 'Yes' and a start date is present, as long as the start date is prior to the date of the subject's initial visit Check that either medication stop date is completed or 'Ongoing Medication?' is 'Yes'. It is acceptable for stop date to be missing if 'Ongoing Medication?' is 'Yes'. Ensure that the 'Reason for Medication' is recorded on one of the following pages using the same terms: Current Medical Conditions Non-Serious Adverse Events Serious Adverse Events Form

Type de données

text

Alias
UMLS CUI [1]
C1519941
Were any concomitant medications taken by the subject prior to and/or during the study?
Description

If Yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name
Description

(Trade Name preferred

Type de données

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Description

Total Daily Dose

Type de données

text

Alias
UMLS CUI [1]
C2348070
units
Description

units

Type de données

text

Alias
UMLS CUI [1]
C1519795
Reason for Medication
Description

Reason for Medication

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date
Description

Start Date

Type de données

text

Alias
UMLS CUI [1]
C0808070
Taken Prior to study?
Description

Taken Prior to study?

Type de données

boolean

Alias
UMLS CUI [1]
C2826667
Stop date
Description

Stop date

Type de données

date

Ongoing Medication?
Description

Ongoing Medication?

Type de données

text

Alias
UMLS CUI [1]
C2826666
Retour au début de la page

Similar models

CONCOMITANT MEDICATIONS

9 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
CONCOMITANT MEDICATIONS
MONITOR DATA VALIDATION CHECKS
Item
MONITOR DATA VALIDATION CHECKS
text
C1519941 (UMLS CUI [1])
Were any concomitant medications taken by the subject prior to and/or during the study?
Item
Were any concomitant medications taken by the subject prior to and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
units
Item
units
text
C1519795 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
text
C0808070 (UMLS CUI [1])
Taken Prior to study?
Item
Taken Prior to study?
boolean
C2826667 (UMLS CUI [1])
Stop date
Item
Stop date
date
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Ongoing Medication?
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Retour au début de la page 

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