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

IF WEEK 12 VISIT

IF WEEK 12 VISIT
Description

IF WEEK 12 VISIT

Instructions FOR WEEK 12
Description

A CTIGRAPHY INSTRUCTIONS 1. Refer to the Study Reference Manual for instructions on collecting and downloading the data from the actigraphy device(s). DIARY INSTRUCTIONS 1. Retrieve and review the Dosing and Actigraphy Diary for the Week 10 to Week 12 Visit PGx INSTRUCTIONS 1. If the subject consented to participate in the PGx-Pharmacogenetic research and has taken at least one dose of study medication, collect the blood sample during this visit. CONCOMITANT MEDICATION 1. Remind the subject he/she is not allowed to take any medication for RLS or that affects sleep until after completion of the Follow-up Visit. SCHEDULING NEXT VISIT 1. Arrange for the subject to return in 7 days(+/- 3 days) for the Follow-Up visit.

Data type

text

Alias
UMLS CUI [1]
C1442085
IF EARLY WITHDRAWAL VISIT
Description

DIARY INSTRUCTIONS 1. Retrieve and review the diary dispensed to the subject at the last study visit PGx INSTRUCTIONS 1. If the subject consented to participate in the PGx-Pharmacogenetic research and has taken at least one dose of study medication, collect the blood sample during this visit. CONCOMITANT MEDICATIONS 1. Remind the subject he/she is not allowed to take any medication for RLS or that affects sleep until after completion of the Follow-up Visit. SCHEDULING NEXT VISIT 1. Arrange for the subject to return in 7 days(+/- 3 days) for the Follow-up Visit.

Data type

text

Alias
UMLS CUI [1]
C2349954
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

Data type

text

Alias
UMLS CUI [1]
C2347852
ADVERSE EVENTS
Description

Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Event section.

Data type

text

Alias
UMLS CUI [1]
C0877248
VITAL SIGNS 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 [1,1]
C0518766
UMLS CUI [1,2]
C1442085
URINE PREGNANCY TEST PROMPT
Description

If subject is female and of childbearing potential a urine pregnancy test must be performed.

Data type

text

Alias
UMLS CUI [1]
C0430056

Similar models

IF WEEK 12 VISIT

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
IF WEEK 12 VISIT
Instruction FOR WEEK 12
Item
Instructions FOR WEEK 12
text
C1442085 (UMLS CUI [1])
IF EARLY WITHDRAWAL VISIT
Item
IF EARLY WITHDRAWAL VISIT
text
C2349954 (UMLS CUI [1])
CONCOMITANT MEDICATIONS
Item
CONCOMITANT MEDICATIONS
text
C2347852 (UMLS CUI [1])
ADVERSE EVENTS
Item
ADVERSE EVENTS
text
C0877248 (UMLS CUI [1])
VITAL SIGNS INSTRUCTIONS
Item
VITAL SIGNS INSTRUCTIONS
text
C0518766 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
URINE PREGNANCY TEST PROMPT
Item
URINE PREGNANCY TEST PROMPT
text
C0430056 (UMLS CUI [1])

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