ID

24780

Beschreibung

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

Stichworte

Versionen (1)
  1. 17.08.17 17.08.17 -
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17. August 2017

DOI

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

Englisch

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

1 Formulare  
Physical Examination
Beschreibung

Physical Examination

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0031809
Pregnancy Test
Beschreibung

Pregnancy Test

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

pregnancy test

Datentyp

boolean

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

reason pregnancy test not done

Datentyp

text

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

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

Datentyp

date

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

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

Datentyp

integer

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

ECG Monitoring

Alias
UMLS CUI-1
C1623258
Date ECG
Beschreibung

Date ECG

Datentyp

date

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

Time ECG

Datentyp

time

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

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR
Beschreibung

PR

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1880446
UMLS CUI [1,2]
C1623258
msec
QRS
Beschreibung

QRS

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1880451
UMLS CUI [1,2]
C1623258
msec
QTC
Beschreibung

QTC

Datentyp

float

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1623258
ECG Comments
Beschreibung

Comments

Datentyp

text

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

Vitals Signs, Follow-up

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

Date

Datentyp

date

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

Time

Datentyp

time

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

systolic Blood pressure

Datentyp

integer

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

diastolic blood pressure

Datentyp

integer

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

Heart rate supine

Datentyp

integer

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

systolic Blood pressure erect

Datentyp

integer

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

diastolic Blood pressure erect

Datentyp

integer

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

Heart rate erect

Datentyp

integer

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

Clinical Chemistry and Haematology

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

Date blood sample taken

Datentyp

date

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

Time blood sample taken

Datentyp

time

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

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

Datentyp

boolean

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

Comments

Datentyp

text

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

Urinalysis

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

Date urine sample taken

Datentyp

date

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

Time urine sample taken

Datentyp

time

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

Comments

Datentyp

text

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0042014
PH Result
Beschreibung

Results for dip stick test

Datentyp

float

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

Results for dip stick test

Datentyp

boolean

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

Results for dip stick test

Datentyp

text

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

Results for dip stick test

Datentyp

float

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

Results for dip stick test

Datentyp

boolean

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

Results for dip stick test

Datentyp

text

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

Glucose

Datentyp

float

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

Glucose

Datentyp

boolean

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

Comments

Datentyp

text

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

Bilirubin

Datentyp

float

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

Bilirubin

Datentyp

boolean

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

Comments

Datentyp

text

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

Blood

Datentyp

text

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

Blood

Datentyp

boolean

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

Comments

Datentyp

text

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

Adverse Event

Alias
UMLS CUI-1
C0877248
Time Point
Beschreibung

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.

Datentyp

integer

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0877248
Pregnancy Information
Beschreibung

Pregnancy Information

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

pregnant

Datentyp

integer

Alias
UMLS CUI [1]
C0032961
Study Conclusion
Beschreibung

Study Conclusion

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

complete study

Datentyp

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
Beschreibung

reason for discontinuation

Datentyp

integer

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

reason for discontinuation

Datentyp

text

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

Comments withdrawal

Datentyp

text

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

Date of Withdrawal

Datentyp

date

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

Time of Withdrawal

Datentyp

time

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

Date of Final Dose

Datentyp

date

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

Time of Final Dose

Datentyp

time

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

Follow up comments

Datentyp

text

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

Investigators Statement

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

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Center Number
Beschreibung

Center Number

Datentyp

text

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

Adverse Event forms

Datentyp

integer

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

Concomitant Medication form

Datentyp

integer

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

pages are signed

Datentyp

integer

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

laboratory results

Datentyp

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
Beschreibung

Investigators signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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