ID

29055

Beskrivning

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

Nyckelord

Versioner (5)
  1. 2017-10-05 2017-10-05 -
  2. 2018-02-22 2018-02-22 -
  3. 2018-02-22 2018-02-22 -
  4. 2018-02-22 2018-02-22 -
  5. 2021-09-17 2021-09-17 -
Rättsinnehavare

gsk

Uppladdad den

22 februari 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Ropinirole Case Report Form GSK RRL100013

Engelsk

CONCOMITANT MEDICATIONS

9 Formulär  
CONCOMITANT MEDICATIONS
Beskrivning

CONCOMITANT MEDICATIONS

MONITOR DATA VALIDATION CHECKS
Beskrivning

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

Datatyp

text

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

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.

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name
Beskrivning

(Trade Name preferred

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1]
C2348070
units
Beskrivning

units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Reason for Medication
Beskrivning

Reason for Medication

Datatyp

text

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

Start Date

Datatyp

text

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

Taken Prior to study?

Datatyp

boolean

Alias
UMLS CUI [1]
C2826667
Stop date
Beskrivning

Stop date

Datatyp

date

Ongoing Medication?
Beskrivning

Ongoing Medication?

Datatyp

text

Alias
UMLS CUI [1]
C2826666
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Similar models

CONCOMITANT MEDICATIONS

9 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
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