ID

33425

Description

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder Checklist for the first screening of the study subject. It should be filled out at the screening visit. Every item should be checked and staff initials should be filled in next to the item. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Keywords

Versions (2)
  1. 12/1/18 12/1/18 -
  2. 12/8/18 12/8/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 8, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Effect of Lamictal on Resting Motor Threshold Study-ID 107434

English

Subject Screening Checklist

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Screening number
Description

Screening No.

Data type

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Subject name
Description

Subject name

Data type

text

Alias
UMLS CUI [1]
C1299487
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
ID Type
Description

ID Type

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of last Trial
Description

Date of last Trial

Data type

text

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2348568
Participation in a clinical trial with an investigational drug 30 days or 5 half lives (whichever is longer) prior to dosing
Description

If yes, please EXCLUDE

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
GP Address, Fax and Tel.
Description

GP Address, Fax and Tel.

Data type

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1442065
UMLS CUI [2,1]
C0017319
UMLS CUI [2,2]
C1549619
UMLS CUI [3,1]
C0017319
UMLS CUI [3,2]
C1515258
GP Disclosure
Description

GP Disclosure

Data type

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C0012625
GP Letter
Description

GP Letter

Data type

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1096774
GP response
Description

GP response

Data type

text

Alias
UMLS CUI [1,1]
C0017319
UMLS CUI [1,2]
C1706817
Screening Consent
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0281974
UMLS CUI [1,2]
C0021430
Study Informed Consent Signed by Physician
Description

Screening part only

Data type

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
UMLS CUI [1,3]
C0031831
Study Informed Consent Signed by Subject
Description

Study Informed Consent Signed by Subject

Data type

text

Alias
UMLS CUI [1]
C0021430
HIV Consent
Description

HIV Consent

Data type

text

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0021430
Pharmacogenetic Consent
Description

Pharmacogenetic Consent

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
Screening Talk
Description

Screening Talk

Data type

text

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0871703
Clinical Assessments
Description

Clinical Assessments

Alias
UMLS CUI-1
C0220825
Height, Weight
Description

Height, Weight

Data type

text

Alias
UMLS CUI [1]
C0005890
UMLS CUI [2]
C0005910
BMI
Description

BMI

Data type

text

Alias
UMLS CUI [1]
C1305855
Semi-Supine Vitals (BP and HR)
Description

Semi-Supine Vitals (BP and HR)

Data type

text

Alias
UMLS CUI [1,1]
C0522019
UMLS CUI [1,2]
C0018810
UMLS CUI [2,1]
C0522019
UMLS CUI [2,2]
C0005823
Medical, Medication History and History
Description

Medical, Medication History and History

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0013227
UMLS CUI [3]
C0031809
12-Lead ECG
Description

12-Lead ECG

Data type

text

Alias
UMLS CUI [1]
C0430456
TMS
Description

TMS

Data type

text

Alias
UMLS CUI [1]
C0436548
EEG with Photostimulation
Description

EEG with Photostimulation

Data type

text

Alias
UMLS CUI [1]
C0430786
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Haematology
Description

4.5ml EDTA

Data type

text

Alias
UMLS CUI [1]
C0018941
Clinical Chemistry
Description

6ml SST

Data type

text

Alias
UMLS CUI [1]
C0008000
Hep B & C + HIV I & II
Description

6ml SST

Data type

text

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
Urinalysis
Description

Urinalysis

Data type

text

Alias
UMLS CUI [1]
C0042014
Urine Microscopy
Description

Urine Microscopy

Data type

text

Alias
UMLS CUI [1]
C0430397
Drugs of Abuse and Alcohol Screen
Description

Drugs of Abuse and Alcohol Screen

Data type

text

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0085762
Conclusion
Description

Conclusion

Alias
UMLS CUI-1
C1707478
If subject is ineligible, please state reason
Description

Reason Subject is Ineligble

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2828389
Clin QC Inits
Description

Clinical QC Initials

Data type

text

Alias
UMLS CUI [1,1]
C0034378
UMLS CUI [1,2]
C2986440
CRM QC Inits
Description

CRM QC Initials

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C0034378
UMLS CUI [2]
C3846158
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Similar models

Subject Screening Checklist

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Screening No.
Item
Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject name
Item
Subject name
text
C1299487 (UMLS CUI [1])
Item Group
General Information
C1508263 (UMLS CUI-1)
ID Type
Item
ID Type
text
C2348585 (UMLS CUI [1])
Date of last Trial
Item
Date of last Trial
text
C0011008 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
Participation in a clinical trial with an investigational drug 30 days or 5 half lives (whichever is longer) prior to dosing
text
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Participation in Clinical Trial with Investigational Drug
Code List
Participation in a clinical trial with an investigational drug 30 days or 5 half lives (whichever is longer) prior to dosing
CL Item
Yes (Yes)
CL Item
No (No)
GP Address, Fax and Tel.
Item
GP Address, Fax and Tel.
text
C0017319 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
C0017319 (UMLS CUI [2,1])
C1549619 (UMLS CUI [2,2])
C0017319 (UMLS CUI [3,1])
C1515258 (UMLS CUI [3,2])
GP Disclosure
Item
GP Disclosure
text
C0017319 (UMLS CUI [1,1])
C0012625 (UMLS CUI [1,2])
GP Letter
Item
GP Letter
text
C0017319 (UMLS CUI [1,1])
C1096774 (UMLS CUI [1,2])
GP response
Item
GP response
text
C0017319 (UMLS CUI [1,1])
C1706817 (UMLS CUI [1,2])
Screening Consent
Item
Screening Consent
text
C0281974 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Study Informed Consent Signed by Physician
Item
Study Informed Consent Signed by Physician
text
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,3])
Study Informed Consent Signed by Subject
Item
Study Informed Consent Signed by Subject
text
C0021430 (UMLS CUI [1])
HIV Consent
Item
HIV Consent
text
C0019682 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Consent
Item
Pharmacogenetic Consent
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Screening Talk
Item
Screening Talk
text
C0220908 (UMLS CUI [1,1])
C0871703 (UMLS CUI [1,2])
Item Group
Clinical Assessments
C0220825 (UMLS CUI-1)
Height, Weight
Item
Height, Weight
text
C0005890 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
BMI
Item
BMI
text
C1305855 (UMLS CUI [1])
Semi-Supine Vitals (BP and HR)
Item
Semi-Supine Vitals (BP and HR)
text
C0522019 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
C0522019 (UMLS CUI [2,1])
C0005823 (UMLS CUI [2,2])
Medical, Medication History and History
Item
Medical, Medication History and History
text
C0262926 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])
12-Lead ECG
Item
12-Lead ECG
text
C0430456 (UMLS CUI [1])
TMS
Item
TMS
text
C0436548 (UMLS CUI [1])
EEG with Photostimulation
Item
EEG with Photostimulation
text
C0430786 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Haematology
Item
Haematology
text
C0018941 (UMLS CUI [1])
Clinical Chemistry
Item
Clinical Chemistry
text
C0008000 (UMLS CUI [1])
Hep B & C + HIV I & II
Item
Hep B & C + HIV I & II
text
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Urinalysis
Item
Urinalysis
text
C0042014 (UMLS CUI [1])
Urine Microscopy
Item
Urine Microscopy
text
C0430397 (UMLS CUI [1])
Drugs of Abuse and Alcohol Screen
Item
Drugs of Abuse and Alcohol Screen
text
C0013146 (UMLS CUI [1])
C0085762 (UMLS CUI [2])
Item Group
Conclusion
C1707478 (UMLS CUI-1)
Reason Subject is Ineligble
Item
If subject is ineligible, please state reason
text
C0566251 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
Clinical QC Initials
Item
Clin QC Inits
text
C0034378 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
CRM QC Initials
Item
CRM QC Inits
text
C2986440 (UMLS CUI [1,1])
C0034378 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
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