ID

26066

Descrição

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

Palavras-chave

Versões (1)
  1. 05/10/2017 05/10/2017 -
Titular dos direitos

gsk

Transferido a

5 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Inclusion Ropinirole Case Report Form GSK RRL10001

Inglês

Inclusion Ropinirole Case Report Form GSK RRL10001

1 Formulários  
Inclusion Criteria
Descrição

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)?
Descrição

Healthy adult

Tipo de dados

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?
Descrição

BMI and weight

Tipo de dados

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?
Descrição

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.

Tipo de dados

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?
Descrição

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.

Tipo de dados

boolean

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

Normal 12-lead ECG

Tipo de dados

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?
Descrição

Normal systolic and diastolic blood pressure

Tipo de dados

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?
Descrição

Written informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Inclusion Ropinirole Case Report Form GSK RRL10001

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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