ID

24780

Beschrijving

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Parkinson Disease Documentation part: Follow-up Visit

Trefwoorden

Versies (1)
  1. 17-08-17 17-08-17 -
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Dose strength equivalence of ropinirole CR in healthy adults Follow-up Visit 101468/219

Engels

Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulieren  
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Have any changes been noted compared to the examination conducted at screening?
Beschrijving

If YES, please enter changes on an Adverse Event page at the back of the CRF

Datatype

boolean

Alias
UMLS CUI [1]
C0031809
Pregnancy Test
Beschrijving

Pregnancy Test

Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0032961
Was a pregnancy test carried out?
Beschrijving

pregnancy test

Datatype

boolean

Alias
UMLS CUI [1]
C0032976
Was a pregnancy test carried out? If No, please specify reason
Beschrijving

reason pregnancy test not done

Datatype

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
Date of pregnancy test
Beschrijving

Was a pregnancy test carried out? If Yes, please specify

Datatype

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test result
Beschrijving

Was a pregnancy test carried out? If Yes, please specify If ’Positive’, withdraw the subject from the study.

Datatype

integer

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
ECG Monitoring
Beschrijving

ECG Monitoring

Alias
UMLS CUI-1
C1623258
Date ECG
Beschrijving

Date ECG

Datatype

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0011008
Time ECG
Beschrijving

Time ECG

Datatype

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0040223
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschrijving

PR

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C1880446
UMLS CUI [1,2]
C1623258
msec
QRS
Beschrijving

QRS

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C1880451
UMLS CUI [1,2]
C1623258
msec
QTC
Beschrijving

QTC

Datatype

float

Maateenheden
  • msec
Alias
UMLS CUI [1,1]
C0860814
UMLS CUI [1,2]
C1623258
msec
ECG clinically significant?
Beschrijving

If the abnormality is clinically significant, please withdraw the subject.

Datatype

boolean

Alias
UMLS CUI [1]
C1623258
ECG Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0947611
Vitals Signs, Follow-up
Beschrijving

Vitals Signs, Follow-up

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1522577
Date of vital sign measurement
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time of vital sign measurement
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure - supine, systolic
Beschrijving

systolic Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood pressure - supine, diastolic
Beschrijving

diastolic blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate - supine
Beschrijving

Heart rate supine

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
Blood pressure - erect, systolic
Beschrijving

systolic Blood pressure erect

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
mmHg
Blood pressure - erect, diastolic
Beschrijving

diastolic Blood pressure erect

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
mmHg
Heart rate - erect
Beschrijving

Heart rate erect

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0231472
beats/min
Clinical Chemistry and Haematology
Beschrijving

Clinical Chemistry and Haematology

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Date blood sample taken
Beschrijving

Date blood sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Time blood sample taken
Beschrijving

Time blood sample taken

Datatype

time

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0040223
Clinical Chemistry and Haematology: Are there clinically significant abnormal values?
Beschrijving

If YES, please record diagnosis on Baseline Signs and Symptom page.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1704258
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0947611
Urinalysis
Beschrijving

Urinalysis

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0200354
Date urine sample taken
Beschrijving

Date urine sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
Time urine sample taken
Beschrijving

Time urine sample taken

Datatype

time

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0040223
Urinalysis Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0947611
Urinalysis: Are there clinically significant abnormal values?
Beschrijving

If YES, please record diagnosis on Baseline Signs and Symptom page.

Datatype

boolean

Alias
UMLS CUI [1]
C0042014
PH Result
Beschrijving

Results for dip stick test

Datatype

float

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0430370
UMLS CUI [2]
C0042014
PH Clinically significant?
Beschrijving

Results for dip stick test

Datatype

boolean

Alias
UMLS CUI [1]
C0042044
UMLS CUI [2]
C0042014
PH Comments
Beschrijving

Results for dip stick test

Datatype

text

Alias
UMLS CUI [1,1]
C0042044
UMLS CUI [1,2]
C0947611
UMLS CUI [2]
C0042014
Protein Result
Beschrijving

Results for dip stick test

Datatype

float

Alias
UMLS CUI [1]
C0262923
UMLS CUI [2]
C0042014
Protein clinically significant?
Beschrijving

Results for dip stick test

Datatype

boolean

Alias
UMLS CUI [1]
C0262923
UMLS CUI [2]
C0042014
Protein Comments
Beschrijving

Results for dip stick test

Datatype

text

Alias
UMLS CUI [1,1]
C0262923
UMLS CUI [1,2]
C0947611
UMLS CUI [2]
C0042014
Glucose Result
Beschrijving

Glucose

Datatype

float

Alias
UMLS CUI [1]
C0004076
UMLS CUI [2]
C0042014
Glucose Clinically Significant?
Beschrijving

Glucose

Datatype

boolean

Alias
UMLS CUI [1]
C0004076
UMLS CUI [2]
C0042014
Glucose Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0004076
UMLS CUI [1,2]
C0947611
UMLS CUI [2]
C0042014
Bilirubin Result
Beschrijving

Bilirubin

Datatype

float

Alias
UMLS CUI [1]
C0344395
UMLS CUI [2]
C0042014
Bilirubin Clinically Significant?
Beschrijving

Bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0344395
UMLS CUI [2]
C0042014
Bilirubin Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0344395
UMLS CUI [1,2]
C0947611
UMLS CUI [2]
C0042014
Blood Result
Beschrijving

Blood

Datatype

text

Alias
UMLS CUI [1]
C0018965
UMLS CUI [2]
C0042014
Blood Clinically Significant?
Beschrijving

Blood

Datatype

boolean

Alias
UMLS CUI [1]
C0018965
UMLS CUI [2]
C0042014
Blood Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1,1]
C0018965
UMLS CUI [1,2]
C0947611
UMLS CUI [2]
C0042014
Adverse Event
Beschrijving

Adverse Event

Alias
UMLS CUI-1
C0877248
Time Point
Beschrijving

Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient "How are you feeling" (pre-dose) and at subsequent schedules intervals post-dose: "Since you were last asked have you felt unwell or different from usual?" Provide the diagnosis not symptoms where possible.

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348792
Any Adverse Event?
Beschrijving

*If "Yes" record all details on an Adverse Event page at back of CRF.

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Pregnancy Information
Beschrijving

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the patient become pregnant during the study?
Beschrijving

pregnant

Datatype

integer

Alias
UMLS CUI [1]
C0032961
Study Conclusion
Beschrijving

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C2349954
Did the subject complete the study as planned?
Beschrijving

complete study

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
Did the subject complete the study as planned? If ’NO’, mark the one most appropriate category
Beschrijving

reason for discontinuation

Datatype

integer

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0392360
Reason for discontinuation, if other please specify
Beschrijving

reason for discontinuation

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0392360
Comments on reason for withdrawal
Beschrijving

Comments withdrawal

Datatype

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0947611
Date of Withdrawal
Beschrijving

Date of Withdrawal

Datatype

date

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0011008
Time of Withdrawal
Beschrijving

Time of Withdrawal

Datatype

time

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0040223
Date of Final Dose
Beschrijving

Date of Final Dose

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Time of Final Dose
Beschrijving

Time of Final Dose

Datatype

time

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1522314
Follow up general comments
Beschrijving

Follow up comments

Datatype

text

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0947611
Investigators Statement
Beschrijving

Investigators Statement

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1710187
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Center Number
Beschrijving

Center Number

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Check all Adverse Event forms are up to date and complete
Beschrijving

Adverse Event forms

Datatype

integer

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0008961
Check that the Concomitant Medication form is up to date
Beschrijving

Concomitant Medication form

Datatype

integer

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0008961
Check that all appropriate pages are signed (thus indicating completion) and dated
Beschrijving

pages are signed

Datatype

integer

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0008961
Check that laboratory results are included
Beschrijving

laboratory results

Datatype

integer

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0008961
I certify that the observtions and findings are recorded correctly and completely in this CRF. Investigators signature
Beschrijving

Investigators signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Follow-up Visit Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
physical examination
Item
Have any changes been noted compared to the examination conducted at screening?
boolean
C0031809 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
C0032961 (UMLS CUI-2)
pregnancy test
Item
Was a pregnancy test carried out?
boolean
C0032976 (UMLS CUI [1])
reason pregnancy test not done
Item
Was a pregnancy test carried out? If No, please specify reason
text
C0032976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test result
integer
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
ECG Monitoring
C1623258 (UMLS CUI-1)
Date ECG
Item
Date ECG
date
C1623258 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time ECG
Item
Time ECG
time
C1623258 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR
Item
PR
float
C1880446 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
QRS
Item
QRS
float
C1880451 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
QTC
Item
QTC
float
C0860814 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
ECG clinically significant
Item
ECG clinically significant?
boolean
C1623258 (UMLS CUI [1])
Comments
Item
ECG Comments
text
C1623258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vitals Signs, Follow-up
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Date
Item
Date of vital sign measurement
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time
Item
Time of vital sign measurement
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
systolic Blood pressure
Item
Blood pressure - supine, systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
diastolic blood pressure
Item
Blood pressure - supine, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate supine
Item
Heart rate - supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
systolic Blood pressure erect
Item
Blood pressure - erect, systolic
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
diastolic Blood pressure erect
Item
Blood pressure - erect, diastolic
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Heart rate erect
Item
Heart rate - erect
integer
C0018810 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
Item Group
Clinical Chemistry and Haematology
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Date blood sample taken
Item
Date blood sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blood sample taken
Item
Time blood sample taken
time
C1277698 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Clinical Chemistry and Haematology
Item
Clinical Chemistry and Haematology: Are there clinically significant abnormal values?
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0005834 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Urinalysis
C0042014 (UMLS CUI-1)
C0200354 (UMLS CUI-2)
Date urine sample taken
Item
Date urine sample taken
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time urine sample taken
Item
Time urine sample taken
time
C0200354 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Urinalysis Comments
text
C0042014 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Urinalysis
Item
Urinalysis: Are there clinically significant abnormal values?
boolean
C0042014 (UMLS CUI [1])
PH
Item
PH Result
float
C0042044 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
PH
Item
PH Clinically significant?
boolean
C0042044 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Comments
Item
PH Comments
text
C0042044 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Protein
Item
Protein Result
float
C0262923 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Protein
Item
Protein clinically significant?
boolean
C0262923 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Comments
Item
Protein Comments
text
C0262923 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Glucose
Item
Glucose Result
float
C0004076 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Glucose
Item
Glucose Clinically Significant?
boolean
C0004076 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Comments
Item
Glucose Comments
text
C0004076 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Bilirubin
Item
Bilirubin Result
float
C0344395 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Bilirubin
Item
Bilirubin Clinically Significant?
boolean
C0344395 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Comments
Item
Bilirubin Comments
text
C0344395 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Blood
Item
Blood Result
text
C0018965 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Blood
Item
Blood Clinically Significant?
boolean
C0018965 (UMLS CUI [1])
C0042014 (UMLS CUI [2])
Comments
Item
Blood Comments
text
C0018965 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C0042014 (UMLS CUI [2])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Item
Time Point
integer
C0877248 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Time Point
Code List
Time Point
CL Item
Pre-dose (1)
CL Item
+1 hrs (2)
CL Item
+4 hrs (3)
CL Item
+6 hrs (4)
CL Item
+12 hrs (5)
CL Item
+24 hrs (6)
CL Item
+36 hrs (7)
Adverse Event
Item
Any Adverse Event?
boolean
C0877248 (UMLS CUI [1])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the patient become pregnant during the study?
integer
C0032961 (UMLS CUI [1])
pregnant
Code List
Did the patient become pregnant during the study?
CL Item
Not applicable (not of childbearing potential or male) (1)
CL Item
No (2)
CL Item
Yes (If ’Yes’ record details on Pregnancy Notification Form) (3)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
complete study
Item
Did the subject complete the study as planned?
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
Did the subject complete the study as planned? If ’NO’, mark the one most appropriate category
integer
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
reason for discontinuation
Code List
Did the subject complete the study as planned? If ’NO’, mark the one most appropriate category
CL Item
Adverse Event (complete Adverse Event Form) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Deviation from Protocol (including non-compliance) (3)
CL Item
Lost to Follow-Up (4)
CL Item
Other (5)
reason for discontinuation
Item
Reason for discontinuation, if other please specify
text
C2349954 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Comments withdrawal
Item
Comments on reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of Withdrawal
Item
Date of Withdrawal
date
C2349954 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Withdrawal
Item
Time of Withdrawal
time
C2349954 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of Final Dose
Item
Date of Final Dose
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Time of Final Dose
Item
Time of Final Dose
time
C0013227 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Follow up comments
Item
Follow up general comments
text
C1522577 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Investigators Statement
C0008961 (UMLS CUI-1)
C1710187 (UMLS CUI-2)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item
Check all Adverse Event forms are up to date and complete
integer
C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Adverse Event forms
Code List
Check all Adverse Event forms are up to date and complete
CL Item
done (1)
CL Item
not done (2)
Item
Check that the Concomitant Medication form is up to date
integer
C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Adverse Event forms
Code List
Check that the Concomitant Medication form is up to date
CL Item
done (1)
CL Item
not done (2)
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
integer
C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Adverse Event forms
Code List
Check that all appropriate pages are signed (thus indicating completion) and dated
CL Item
done (1)
CL Item
not done (2)
Item
Check that laboratory results are included
integer
C1283174 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
Adverse Event forms
Code List
Check that laboratory results are included
CL Item
done (1)
CL Item
not done (2)
Investigators signature
Item
I certify that the observtions and findings are recorded correctly and completely in this CRF. Investigators signature
text
C2346576 (UMLS CUI [1])
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