Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Adverse Event
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1])
Concomitant Medication
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1])
completion
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C0805732 (UMLS CUI [1])
laboratory results
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1])
consent
Item
I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.
boolean
C1511481 (UMLS CUI [1])
Investigator
Item
Investigator
text
C2826892 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])