ID

29055

Beschrijving

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

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Versies (5)
  1. 05-10-17 05-10-17 -
  2. 22-02-18 22-02-18 -
  3. 22-02-18 22-02-18 -
  4. 22-02-18 22-02-18 -
  5. 17-09-21 17-09-21 -
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gsk

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22 februari 2018

DOI

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

Engels

STATUS OF TREATMENT BLIND

9 Formulieren  
Status
Beschrijving

Status

Was the treatment blind broken during the study?
Beschrijving

If Yes, complete the following

Datatype

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Date blind broken
Beschrijving

Date blind broken

Datatype

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2347038
Reason blind broken
Beschrijving

Complete Non-Serious Adverse Events or Serious Adverse Event pages, as appropriate.

Datatype

integer

Alias
UMLS CUI [1]
C0392360
PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
Beschrijving

PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS

PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
Beschrijving

The question "Has informed consent been obtained for PGx-Pharmacogenetic research?" should be completed at the beginning of the study. If the question is answered No, I/ one box for reason and do not complete the remainder of the page. WITHDRAWAL OF CONSENT The question "Has the subject withdrawn consent for PGx-Pharmacogenetic research?" must be completed immediately if the subject withdraws consent. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom informed consent was obtained for PGx-Pharmacogenetic research. If consent is withdrawn, a request for destruction must be made and Blood Sample Destruction section below completed. BLOOD SAMPLE DESTRUCT/ON Do not complete this section if a blood sample was not collected. The question "Has a request been made for sample destruction?" must be completed immediately if there is a request for sample destruction. Otherwise, it must be completed when the subject leaves the study. It must be completed for all subjects for whom a blood sample was obtained for PGx-Pharmacogenetic research. If the question is answered Yes, I/one box for reason.

Datatype

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C1442085
PGx-PHARMACOGENETIC RESEARCH
Beschrijving

PGx-PHARMACOGENETIC RESEARCH

CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Beschrijving

CONSENT FOR PGx-PHARMACOGENETIC RESEARCH

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Beschrijving

Informed consent if yes

Datatype

date

Alias
UMLS CUI [1]
C2985782
Informed consent if no
Beschrijving

Informed consent if no

Datatype

text

Alias
UMLS CUI [1]
C0021430
Has a blood sample been collected for PGx-pharmacogenetic research?
Beschrijving

BLOOD SAMPLE COLLECTION

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
If Yes, record the date sample taken
Beschrijving

If Yes, record the date sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschrijving

WITHDRAWAL OF CONSENT

Datatype

boolean

Alias
UMLS CUI [1]
C1707492
BLOOD SAMPLE DESTRUCTION
Beschrijving

BLOOD SAMPLE DESTRUCTION

Datatype

boolean

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
If Yes: BLOOD SAMPLE DESTRUCTION
Beschrijving

If Yes: BLOOD SAMPLE DESTRUCTION

Datatype

integer

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
CONCOMITANT MEDICATIONS
Beschrijving

The following lists of abbreviations are examples which can be used to aid the completion of the appropriate items on the Concomitant Medications page. These are not all inclusive lists and are for guidance only, other abbreviations not listed may be used if necessary.

Datatype

text

Alias
UMLS CUI [1]
C2347852
UNITS
Beschrijving

UNITS

Datatype

text

Alias
UMLS CUI [1]
C1519795
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Similar models

STATUS OF TREATMENT BLIND

9 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Status
Was the treatment blind broken during the study?
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date blind broken
Item
Date blind broken
datetime
C0011008 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Item
Reason blind broken
integer
C0392360 (UMLS CUI [1])
Reason blind broken
Code List
Reason blind broken
CL Item
Medical emergency requiring identification of investigation al product for further treatment (1)
C0013961 (UMLS CUI-1)
(Comment:en)
CL Item
Other, specify (2)
C1521902 (UMLS CUI-1)
(Comment:en)
Item Group
PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
Item
PGx-PHARMACOGENETIC RESEARCH INSTRUCTIONS
text
C0031325 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
PGx-PHARMACOGENETIC RESEARCH
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
Item
CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
Item
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2985782 (UMLS CUI [1])
Item
Informed consent if no
text
C0021430 (UMLS CUI [1])
Informed consent if no
Code List
Informed consent if no
CL Item
Subject declined (Subject declined)
CL Item
Subject not asked by Investigator (Subject not asked by Investigator)
CL Item
Other, specify (Other, specify)
BLOOD SAMPLE COLLECTION
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1])
If Yes, record the date sample taken
Item
If Yes, record the date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
WITHDRAWAL OF CONSENT
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C1707492 (UMLS CUI [1])
BLOOD SAMPLE DESTRUCTION
Item
BLOOD SAMPLE DESTRUCTION
boolean
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Item
If Yes: BLOOD SAMPLE DESTRUCTION
integer
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
If Yes: BLOOD SAMPLE DESTRUCTION
Code List
If Yes: BLOOD SAMPLE DESTRUCTION
CL Item
Subject requested (1)
CL Item
Other, specify (2)
CONCOMITANT MEDICATIONS
Item
CONCOMITANT MEDICATIONS
text
C2347852 (UMLS CUI [1])
Item
UNITS
text
C1519795 (UMLS CUI [1])
UNITS
Code List
UNITS
CL Item
Tablet (TAB)
C0039225 (UMLS CUI-1)
(Comment:en)
CL Item
Micro litre (MCL)
C1519795 (UMLS CUI-1)
(Comment:en)
CL Item
Millilitre (ML)
(Comment:en)
CL Item
Litre (L)
(Comment:en)
CL Item
Microgram (MCG)
(Comment:en)
CL Item
Milligram (MG)
(Comment:en)
CL Item
Gram (G)
(Comment:en)
CL Item
Optional therapeutic specific code (?)
(Comment:en)
CL Item
Optional therapeutic specific code (?)
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