Check Adverse Event forms
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Check Concomitant Medication form
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
Check signatures
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Check laboratory results
Item
Check that laboratory results are included
boolean
C1283174 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
Signature Principal Investigator
Item
Signature Principal Investigator
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])