Item
Tracking Document Safety Follow-Up
integer
C3889409 (UMLS CUI [1])
Code List
Tracking Document Safety Follow-Up
CL Item
Prospective Follow-Up for all subjects (1)
(Comment:en)
CL Item
Retrospective Safety Follow-Up (time elapsed between the last contact of the preceding study and the new study contact as specified in the protocol.) (2)
(Comment:en)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject initials
Item
Subject initials first name family name
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of birth
Item
Date of birth (day month year)
date
C0421451 (UMLS CUI [1])
Item
Did the subject experience any SAE(s) since the last contact?
integer
C1519255 (UMLS CUI [1])
Code List
Did the subject experience any SAE(s) since the last contact?
CL Item
Yes, please complete the Safety Follow-up Serious Adverse Event (SAE) form (1)
CL Item
Unknown (subject lost to follow-up or could not be reached) (3)
Date of Contact
Item
Date of Contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Signature
Item
Investigator signature:
text
C2346576 (UMLS CUI [1])
Name of Investigator
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])