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

Keywords

  1. 10/5/17 10/5/17 -
  2. 2/22/18 2/22/18 -
  3. 2/22/18 2/22/18 -
  4. 2/22/18 2/22/18 -
  5. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

February 22, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Ropinirole Case Report Form GSK RRL100013

Investigator INSTRUCTIONS

Investigator Instructions
Description

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Investigator Instructions
Description

Semi-supine measurements must be taken first, followed straight away by the standing measurements. Blood pressure and pulse rate measurements must be recorded in both the semi-supine and standing position. Semi-supine will be defined as the subject lying flat with two pillows under his/her head. Semi-supine pulse and blood measurements will be made after the subject has been resting semi-supine for a period of at least 10 minutes. A standing blood pressure and pulse measurement will be taken after the subject has been standing for a period of one minute. Any clinically significant worsening will be recorded on the Adverse Event or SAE page of the CRF. Blood pressure measurements should not be conducted within 15 minutes of a blood sample. If the blood pressure measurement is conducted after the blood sample, you should ensure that the subject has recovered from the venepuncture before the blood pressure measurement. The blood pressure cuff must be placed on the same arm throughout the study. The same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit. Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each patient throughout the study.

Data type

text

Alias
UMLS CUI [1]
C1442085

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Investigator INSTRUCTIONS

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigator Instructions
C1442085 (UMLS CUI-1)
Investigator Instructions
Item
Investigator Instructions
text
C1442085 (UMLS CUI [1])

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