Englisch

Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Liver Events Assessment
Beschreibung

Liver Events Assessment

Alias
UMLS CUI-1
C0232741
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschreibung

To be checked on Session Days 1 pre-dose, 2 hours post-dose and 72 hours post-dose. If Yes, - Stop investigational product and complete date stopped on Investigational Product form. - Contact GSK within 24 hours of occurrence of liver event by phone or fax. - If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. - Obtain tests as per protocol. - Obtain Blood sample for pharmacokinetic (PK) analysis within 24 hours of last dose. - Complete Liver Events Forms.

Datentyp

text

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C3897431
Was the treatment blind broken during the study?
Beschreibung

Treatment Blind Broken

Datentyp

text

Alias
UMLS CUI [1]
C3897431
If yes, date blind broken
Beschreibung

This is the date the Investigator is made aware of the blind being broken. Record either: Date blind was broken by Investigator or Date Investigator notified by GSK that the blind has been/was broken

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
If yes, time blind broken
Beschreibung

Time blind broken

Datentyp

time

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0040223
Reason blind broken, pick one
Beschreibung

Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Other Reason blind broken, specify
Beschreibung

Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
Pregnancy Information
Beschreibung

Pregnancy Information

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

If Yes, complete Pregnancy Notification form. Not Applicable: not of childbearing potential or male

Datentyp

text

Alias
UMLS CUI [1]
C3828490
Did a female partner of the male subject become pregnant during the study?
Beschreibung

If Yes, complete Pregnancy Notification form. Not Applicable: subject is female, female partner not of childbearing potential or no female partner)

Datentyp

text

Alias
UMLS CUI [1,1]
C3828490
UMLS CUI [1,2]
C0919624
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Beschreibung

Refer to protocol section(s) to evaluate subject completion or withdrawal from the study. If the subject completed the study: ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. If the subject withdrew from the study: ’Date of decision to withdraw’ must match the date of subject withdrawal. ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note:An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschreibung

Withdrawal from study

Datentyp

text

Alias
UMLS CUI [1]
C0422727
If Yes, pick one primary reason for withdrawal:
Beschreibung

If Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. Withdrew consent: Only pick, if none of the other primary reasons are appropriate

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Specify reason for withdrawal
Beschreibung

Reason for withdrawal

Datentyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0947611
Date of decision to withdraw
Beschreibung

Date of decision to withdraw

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Investigator Comment Log
Beschreibung

Investigator Comment Log

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C0947611
CRF patge number if applicable
Beschreibung

CRF page number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C1516308
Comment
Beschreibung

Only use this to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's name (print)
Beschreibung

Investigator's name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Signature date
Beschreibung

Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0232741 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Liver Events Assessment
Code List
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Status of Treatment Blind
C3897431 (UMLS CUI-1)
Item
Was the treatment blind broken during the study?
text
C3897431 (UMLS CUI [1])
Treatment Blind Broken
Code List
Was the treatment blind broken during the study?
CL Item
Yes (Y)
CL Item
No (N)
Date blind broken
Item
If yes, date blind broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time blind broken
Item
If yes, time blind broken
time
C3897431 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Reason blind broken, pick one
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason blind broken
Code List
Reason blind broken, pick one
CL Item
Medical emergency requiring identification of investigational product for further treatment (1)
CL Item
Other (Z)
Other Reason blind broken
Item
Other Reason blind broken, specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Subject pregnant during study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
Item
Did a female partner of the male subject become pregnant during the study?
text
C3828490 (UMLS CUI [1,1])
C0919624 (UMLS CUI [1,2])
Subject pregnant during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (X)
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Liver Events Assessment
Code List
Was the subject withdrawn from the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
If Yes, pick one primary reason for withdrawal:
integer
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary Reason for withdrawal
Code List
If Yes, pick one primary reason for withdrawal:
CL Item
Adverse Event (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to follow-up (6)
CL Item
Withdrew consent (8)
Reason for withdrawal
Item
Specify reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Date of decision to withdraw
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Investigator Comment Log
C0008961 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
CRF page number
Item
CRF patge number if applicable
integer
C1704732 (UMLS CUI [1,1])
C1516308 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])
Signature Date
Item
Signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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