Visit Name
Item
Visit Name
text
C2826704 (UMLS CUI [1])
CRF Page Number
Item
CRF Page Number (if applicable)
integer
C1516308 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Description of Deviation
Item
Description
text
C1705236 (UMLS CUI [1])
Site Personnel Initials
Item
Site Personnel Initials
text
C2986440 (UMLS CUI [1,1])
C2985654 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Deviation Type
Item
Type: preapproved
boolean
C1705236 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item
Type
integer
C1705236 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
02 Outside of Window (2)
CL Item
03 Excluded Prior Therapy (3)
CL Item
04 Excluded Concomitant Medication (4)
CL Item
05 Value Out of Range (5)
CL Item
06 Same Method Not Used (6)
CL Item
07 lncorrect Dose (7)
CL Item
08 Dose Not Held (8)
CL Item
09 Dose Not Reduced (9)
CL Item
10 Dose Not Escalated (10)
CL Item
11 lncorrectly Assigned or Stratified (11)
CL Item
12 Other - Use Only As A Last Resort (12)
Monitor Name
Item
Monitor Name
text
C0027365 (UMLS CUI [1,1])
C1521743 (UMLS CUI [1,2])
Monitor Signature
Item
Monitor signature
text
C1519316 (UMLS CUI [1,1])
C1521743 (UMLS CUI [1,2])
Signature Date
Item
Signature Date
date
C1519316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])