ID

25757

Beskrivning

Study ID: 101468/169 Clinical Study ID: 101468/169 Study Title:A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00381472 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Parkinson Disease This is the Week 20 form.

Nyckelord

Versioner (1)
  1. 2017-09-17 2017-09-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 september 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 :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

Inga kommentarer

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

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 20 101468/169 NCT00381472

Engelsk

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 20 101468/169 NCT00381472

1 Formulär  
DIARY INFORMATION
Beskrivning

DIARY INFORMATION

Alias
UMLS CUI-1
C3890583
Date of diary day 1
Beskrivning

Date of diary day 1

Datatyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Total time asleep
Beskrivning

Total time asleep

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0037313
Total awake time ’Off’
Beskrivning

awake time off

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time ’On’
Beskrivning

awake time On

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time "On" with troublesome dyskinesias
Beskrivning

awake time dyskinesias

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
UMLS CUI [1,3]
C0013384
Date of diary day 2
Beskrivning

Date of diary day 2

Datatyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0011008
Total time asleep
Beskrivning

Total time asleep

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0037313
Total awake time ’Off’
Beskrivning

awake time Off

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time ’On’
Beskrivning

awake time On

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
Total awake time "On" with troublesome dyskinesias
Beskrivning

awake time dyskinesias

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0234422
UMLS CUI [1,3]
C0013384
General Information
Beskrivning

General Information

Alias
UMLS CUI-1
C1508263
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
SUBJECT CONTINUATION
Beskrivning

SUBJECT CONTINUATION

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
Beskrivning

Subject continuation

Datatyp

boolean

Alias
UMLS CUI [1]
C0805733
ADVERSE EVENTS PROMPT
Beskrivning

ADVERSE EVENTS PROMPT

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

Adverse Events

Datatyp

boolean

Alias
UMLS CUI [1]
C0877248
CONCOMITANT MEDICATION PROMPT
Beskrivning

CONCOMITANT MEDICATION PROMPT

Alias
UMLS CUI-1
C2347852
Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
Beskrivning

Concomitant Medication

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
L-DOPA MEDICATION CHANGES
Beskrivning

L-DOPA MEDICATION CHANGES

Alias
UMLS CUI-1
C0023570
UMLS CUI-2
C0023570
Has there been any change in dose or frequency of L-Dopa medication since the last visit?
Beskrivning

change L-Dopa medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
If Yes, tick the primary reason for change:
Beskrivning

reason for change

Datatyp

integer

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0392360
Other, specify
Beskrivning

reason for change

Datatyp

text

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0023570
UMLS CUI [1,3]
C0392360
VITAL SIGNS
Beskrivning

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Blood Pressure Systolic
Beskrivning

Semi-Supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beskrivning

Semi-Supine

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beskrivning

Semi-Supine

Datatyp

integer

Måttenheter
  • beats/min
beats/min
Blood Pressure Systolic
Beskrivning

Standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Diastolic
Beskrivning

Standing

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart Rate
Beskrivning

Standing

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING
Beskrivning

SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING

Alias
UMLS CUI-1
C0458244
Date of food diary
Beskrivning

Date of food diary

Datatyp

date

Alias
UMLS CUI [1,1]
C0458244
UMLS CUI [1,2]
C0458244
Time study medication taken
Beskrivning

Time study medication taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
Time of finishing breakfast:
Beskrivning

Time of finishing breakfast

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2698559
Time of finishing lunch:
Beskrivning

Time of finishing lunch

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2697949
Time of finishing dinner:
Beskrivning

Time of finishing dinner

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C4048877
SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING
Beskrivning

SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING

Alias
UMLS CUI-1
C0458244
Date of food diary
Beskrivning

Date of food diary

Datatyp

date

Alias
UMLS CUI [1,1]
C0458244
UMLS CUI [1,2]
C0458244
Time study medication taken
Beskrivning

Time study medication taken

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
Time of finishing breakfast:
Beskrivning

Time of finishing breakfast

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2698559
Time of finishing lunch:
Beskrivning

Time of finishing lunch

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2697949
Time of finishing dinner:
Beskrivning

Time of finishing dinner

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C4048877
PHARMACOKINETICS - BLOOD
Beskrivning

PHARMACOKINETICS - BLOOD

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
If week 20 is a morning clinic : • A pre-dose blood sample should be taken as soon as possible after the subject arrives at the clinic. The morning dose of study medication should be taken as soon as is practical after this blood sample (please record exact time in the diary card). • Record the exact time that the blood sample was taken in the "am" section of the CRF • No further blood samples are required at this visit.
Beskrivning

morning clinic

Datatyp

boolean

Alias
UMLS CUI [1]
C0178913
If Week 20 is an afternoon clinic : • A blood sample should be taken during the afternoon clinic between 5 and 10 hours after the morning dose. • Record the exact time that the blood sample was taken in the "pm" section of the CRF • No further blood samples are required at this visit.
Beskrivning

afternoon clinic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0178913
Pre-dose Date Sample Taken AM visit
Beskrivning

Pre-dose Date Sample Taken AM visit

Datatyp

date

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0178913
Pre-dose Actual Time AM visit
Beskrivning

Pre-dose Actual Time AM visit

Datatyp

time

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0178913
Pre-Dose Attach Sample Identifier Label Here AM visit
Beskrivning

Pre-Dose Attach Sample Identifier Label Here AM visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0439565
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0600091
5-10 hrs Post-dose Date Sample Taken PM visit
Beskrivning

5-10 hrs Post-dose Date Sample Taken PM visit

Datatyp

date

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0178913
5-10 hrs Post-dose Actual Time PM visit
Beskrivning

5-10 hrs Post-dose Actual Time PM visit

Datatyp

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0178913
Attach Sample Identifier Label Here PM visit
Beskrivning

Attach Sample Identifier Label Here PM visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0600091
CLINICAL GLOBAL IMPRESSION
Beskrivning

CLINICAL GLOBAL IMPRESSION

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION
Beskrivning

CLINICAL GLOBAL IMPRESSION

Datatyp

boolean

Alias
UMLS CUI [1]
C3639708
INVESTIGATIONAL PRODUCT
Beskrivning

INVESTIGATIONAL PRODUCT

Alias
UMLS CUI-1
C0304229
Blinded Dose Level
Beskrivning

Blinded Dose Level

Datatyp

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0304229
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
Stop Date
Beskrivning

Stop Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
Investigational product Container Number
Beskrivning

Investigational product Container Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C3898691
UMLS CUI [1,2]
C0449788
COMPLIANCE
Beskrivning

COMPLIANCE

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Beskrivning

Total number of Tablets Dispensed

Datatyp

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Beskrivning

Total number of Tablets Returned

Datatyp

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Has the subject missed investigational product for more than 3 consecutive days?
Beskrivning

Has the subject missed investigational product for more than 3 consecutive days?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0304229
DISPENSING
Beskrivning

DISPENSING

Alias
UMLS CUI-1
C0947323
Record dispensing information in the Investigational Product and Compliance sections at the next visit.
Beskrivning

Dispense investigational product

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0013230
DIARY CARD
Beskrivning

DIARY CARD

Alias
UMLS CUI-1
C3890583
UMLS CUI-2
C3812666
UMLS CUI-3
C1457887
Issue the subject with Week 24 Diary Card
Beskrivning

Diary Card

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C3812666
UMLS CUI [1,3]
C1457887
CONTINUATION
Beskrivning

CONTINUATION

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0947630
Remind the subject of the scheduled appointment time for the Week 24 Visit.
Beskrivning

appointments

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0947630
UMLS CUI [1,3]
C0545082
If the Week 24 clinic is a morning visit, remind the subject not to take their morning dose of study medication at home on the day of the next clinic.
Beskrivning

dose of study medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0947630
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0013230
If the Week 24 clinic is an afternoon visit, remind the subject to take their morning dose as usual.
Beskrivning

morning dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0947630
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0013230
Remind the subject. To record the exact time that they took their medication on the day prior to the visit and, for afternoon appointments, on the visit day.
Beskrivning

medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0947630
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C0040223
Remind the subject. To record the time that they finished their meals on the day prior to the visit.
Beskrivning

meals

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0947630
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1998602
Tillbaka till toppen

Similar models

GSK Ropinirole in Patients Suffering from Parkinsons Disease Week 20 101468/169 NCT00381472

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
DIARY INFORMATION
C3890583 (UMLS CUI-1)
Date of diary day 1
Item
Date of diary day 1
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
awake time off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time dyskinesias
Item
Total awake time "On" with troublesome dyskinesias
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
Date of diary day 2
Item
Date of diary day 2
date
C3890583 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Total time asleep
Item
Total time asleep
time
C0040223 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
awake time Off
Item
Total awake time ’Off’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time On
Item
Total awake time ’On’
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
awake time dyskinesias
Item
Total awake time "On" with troublesome dyskinesias
time
C0040223 (UMLS CUI [1,1])
C0234422 (UMLS CUI [1,2])
C0013384 (UMLS CUI [1,3])
Item Group
General Information
C1508263 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
SUBJECT CONTINUATION
C0805733 (UMLS CUI-1)
Subject continuation
Item
If the subject is not continuing in the study, do not complete this visit but enter appropriate details on the Study Conclusion page. Continuing?
boolean
C0805733 (UMLS CUI [1])
Item Group
ADVERSE EVENTS PROMPT
Adverse Events
Item
Record details of any new adverse events/serious adverse events observed or reported by the subject or any changes to ongoing adverse events in the appropriate Adverse Events/Serious Adverse Events section.
boolean
C0877248 (UMLS CUI [1])
Item Group
CONCOMITANT MEDICATION PROMPT
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Record any changes to the subject’s concomitant medication or any new medications taken since the last visit in the appropriate Concomitant Medication section.
boolean
C2347852 (UMLS CUI [1])
Item Group
L-DOPA MEDICATION CHANGES
C0023570 (UMLS CUI-1)
C0023570 (UMLS CUI-2)
change L-Dopa medication
Item
Has there been any change in dose or frequency of L-Dopa medication since the last visit?
boolean
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
Item
If Yes, tick the primary reason for change:
integer
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for change
Code List
If Yes, tick the primary reason for change:
CL Item
Reduction required by protocol (starting at dose level 4)  (1)
CL Item
Unacceptable dopaminergic side-effect (Record in the Adverse Events section)  (2)
CL Item
Loss of efficacy  (3)
CL Item
Other, specify (4)
reason for change
Item
Other, specify
text
C0023570 (UMLS CUI [1,1])
C0023570 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
SUBJECT’S FOOD INTAKE DAY BEFORE PK SAMPLING
C0458244 (UMLS CUI-1)
Date of food diary
Item
Date of food diary
date
C0458244 (UMLS CUI [1,1])
C0458244 (UMLS CUI [1,2])
Time study medication taken
Item
Time study medication taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Time of finishing breakfast
Item
Time of finishing breakfast:
time
C0040223 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
Time of finishing lunch
Item
Time of finishing lunch:
time
C0040223 (UMLS CUI [1,1])
C2697949 (UMLS CUI [1,2])
Time of finishing dinner
Item
Time of finishing dinner:
time
C0040223 (UMLS CUI [1,1])
C4048877 (UMLS CUI [1,2])
Item Group
SUBJECT’S FOOD INTAKE ON THE DAY OF PK SAMPLING
C0458244 (UMLS CUI-1)
Date of food diary
Item
Date of food diary
date
C0458244 (UMLS CUI [1,1])
C0458244 (UMLS CUI [1,2])
Time study medication taken
Item
Time study medication taken
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Time of finishing breakfast
Item
Time of finishing breakfast:
time
C0040223 (UMLS CUI [1,1])
C2698559 (UMLS CUI [1,2])
Time of finishing lunch
Item
Time of finishing lunch:
time
C0040223 (UMLS CUI [1,1])
C2697949 (UMLS CUI [1,2])
Time of finishing dinner
Item
Time of finishing dinner:
time
C0040223 (UMLS CUI [1,1])
C4048877 (UMLS CUI [1,2])
Item Group
PHARMACOKINETICS - BLOOD
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
morning clinic
Item
If week 20 is a morning clinic : • A pre-dose blood sample should be taken as soon as possible after the subject arrives at the clinic. The morning dose of study medication should be taken as soon as is practical after this blood sample (please record exact time in the diary card). • Record the exact time that the blood sample was taken in the "am" section of the CRF • No further blood samples are required at this visit.
boolean
C0178913 (UMLS CUI [1])
afternoon clinic
Item
If Week 20 is an afternoon clinic : • A blood sample should be taken during the afternoon clinic between 5 and 10 hours after the morning dose. • Record the exact time that the blood sample was taken in the "pm" section of the CRF • No further blood samples are required at this visit.
boolean
C0178913 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
Pre-dose Date Sample Taken AM visit
Item
Pre-dose Date Sample Taken AM visit
date
C0439565 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Pre-dose Actual Time AM visit
Item
Pre-dose Actual Time AM visit
time
C0439565 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Pre-Dose Attach Sample Identifier Label Here AM visit
Item
Pre-Dose Attach Sample Identifier Label Here AM visit
text
C0439565 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
5-10 hrs Post-dose Date Sample Taken PM visit
Item
5-10 hrs Post-dose Date Sample Taken PM visit
date
C0439568 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
5-10 hrs Post-dose Actual Time PM visit
Item
5-10 hrs Post-dose Actual Time PM visit
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Attach Sample Identifier Label Here PM visit
Item
Attach Sample Identifier Label Here PM visit
text
C0439568 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Item Group
CLINICAL GLOBAL IMPRESSION
C3639708 (UMLS CUI-1)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
Item Group
INVESTIGATIONAL PRODUCT
C0304229 (UMLS CUI-1)
Blinded Dose Level
Item
Blinded Dose Level
integer
C0178602 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Investigational product Container Number
Item
Investigational product Container Number
integer
C3898691 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
COMPLIANCE
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Has the subject missed investigational product for more than 3 consecutive days?
Item
Has the subject missed investigational product for more than 3 consecutive days?
boolean
C1321605 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item Group
DISPENSING
C0947323 (UMLS CUI-1)
Dispense investigational product
Item
Record dispensing information in the Investigational Product and Compliance sections at the next visit.
boolean
C0947323 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item Group
DIARY CARD
C3890583 (UMLS CUI-1)
C3812666 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
Diary Card
Item
Issue the subject with Week 24 Diary Card
boolean
C3890583 (UMLS CUI [1,1])
C3812666 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
CONTINUATION
C0805733 (UMLS CUI-1)
C0947630 (UMLS CUI-2)
appointments
Item
Remind the subject of the scheduled appointment time for the Week 24 Visit.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
dose of study medication
Item
If the Week 24 clinic is a morning visit, remind the subject not to take their morning dose of study medication at home on the day of the next clinic.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
morning dose
Item
If the Week 24 clinic is an afternoon visit, remind the subject to take their morning dose as usual.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
medication
Item
Remind the subject. To record the exact time that they took their medication on the day prior to the visit and, for afternoon appointments, on the visit day.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
meals
Item
Remind the subject. To record the time that they finished their meals on the day prior to the visit.
boolean
C0805733 (UMLS CUI [1,1])
C0947630 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,4])
Tillbaka till toppen 

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