Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event since the last visit of HPV-007?
boolean
C1519255 (UMLS CUI [1])
Serious Adverse Event, Numbers
Item
Specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Did the subject become pregnant since the last visit of HPV-007?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Code List
Did the subject become pregnant since the last visit of HPV-007?
CL Item
Not Applicable (3)
Subject Unblinding Event Record
Item
Was the treatment blind broken during the study?
boolean
C3897431 (UMLS CUI [1])
Subject Unblinding Event Record, Date in time
Item
If Yes, complete Date
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If Yes, tick one reason below
text
C3897431 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
If Yes, tick one reason below
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
Exclusion Criteria
Item
Did any elimination criteria become applicable during the study?
boolean
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Specify
text
C0680251 (UMLS CUI [1])
Withdraw
Item
Was the subject withdrawn from the study?
boolean
C2349954 (UMLS CUI [1])
Item
Major reason for withdrawal (tick one box only)
text
C2349954 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Major reason for withdrawal (tick one box only)
CL Item
Serious adverse event (Please complete and submit SAE report, Please specify SAE No.) (1)
CL Item
Non-Serious adverse event (Please complete Non-serious Adverse Event section, Please specify AE No.) (2)
CL Item
Protocol violation (please specify) (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Administration of any HPV vaccine other than that used in study HPV-001 (5)
CL Item
Unblinding to allow the subject to decide if she will consider immunization with a licensed HPV vaccine. (6)
CL Item
Migrated / moved from the study area (7)
CL Item
Lost to follow-up. (8)
CL Item
Other, please specify (9)
Item
Who made the decision?
text
C2349954 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Code List
Who made the decision?
Withdraw Date last contact
Item
Date of last contact
date
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Withdraw, Date last contact, General physical condition
Item
Was the subject in good condition at date of last contact?
boolean
C2349954 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Colposcopy, Diagram, Lesion, Location, Type
Item
Please indicate in the diagram the precise type(s) and location(s) of lesion(s) according to the abbreviated list below.
text
C0009417 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Code List
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
CL Item
Quality Assurance of tests described in the protocol. This may include the management of t equality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably. (1)
CL Item
Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetics and HIV testing. (2)
CL Item
Further investigation by GSK Biologicals into the ability of HPV- vaccine to protect people if any findings from related studies require it and further research in cervical cancer. These investigations excludes genetic and HIV testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed. (3)
Item
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Code List
Please tick below box if a 15 years GSK storage period is covered by the subject’s Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other,specify (2)
Date in time, Consent Forms
Item
ICF Effective date
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier, Previous
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Reason for non participation
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
Reason for non participation
CL Item
Subject not eligible (Please specify criteria that are not fulfilled) (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to Adverse event(s), or serious adverse event (Please specify), Other (Please specify) (3)
CL Item
Subject died on (4)
Item
Reason for non participation - Specifications
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
Reason for non participation - Specifications
Date last contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])