ID

26066

Beskrivning

Inclusion Ropinirole Case Report Form Concomitant Medication Ropinirole Case Report Form 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 (1)
  1. 2017-10-05 2017-10-05 -
Rättsinnehavare

gsk

Uppladdad den

5 oktober 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Inclusion Ropinirole Case Report Form GSK RRL10001

Engelsk

Inclusion Ropinirole Case Report Form GSK RRL10001

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
Beskrivning

Healthy adult

Datatyp

boolean

Alias
UMLS CUI [1]
C0686750
2. Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight ≥50 kg?
Beskrivning

BMI and weight

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
3. Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
Beskrivning

A subject with a clinical abnormality may be included only if the Principal Investigator, in agreement with the Sponsor, considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.

Datatyp

boolean

Alias
UMLS CUI [1]
C0855737
4. Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
Beskrivning

Subjects with laboratory values outside the reference range for this age group will only be included if the Principal Investigator, in agreement with the Sponsor, considers that such findings will not introduce additional risk factors.

Datatyp

boolean

Alias
UMLS CUI [1]
C0438214
5. Is the 12-lead ECG at the pre-study screening normal?
Beskrivning

Normal 12-lead ECG

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0459422
6. Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
Beskrivning

Normal systolic and diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0277882
UMLS CUI [2]
C0277887
7. Does the subject give a written informed consent prior to admission to the study?
Beskrivning

Written informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Tillbaka till toppen

Similar models

Inclusion Ropinirole Case Report Form GSK RRL10001

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy adult
Item
1. Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
boolean
C0686750 (UMLS CUI [1])
BMI and weight
Item
2. Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight ≥50 kg?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Physical examination normal
Item
3. Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
boolean
C0855737 (UMLS CUI [1])
Normal laboratory parameters
Item
4. Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
boolean
C0438214 (UMLS CUI [1])
Normal 12-lead ECG
Item
5. Is the 12-lead ECG at the pre-study screening normal?
boolean
C0430456 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Normal systolic and diastolic blood pressure
Item
6. Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
boolean
C0277882 (UMLS CUI [1])
C0277887 (UMLS CUI [2])
Written informed consent
Item
7. Does the subject give a written informed consent prior to admission to the study?
boolean
C0021430 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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