PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Reported Date
Item
Reported Date
date
C1302584 (UMLS CUI [1])
Reported By
Item
Reported By
text
C0700287 (UMLS CUI [1])
Description of Deviation
Item
Description of Deviation
text
C1705236 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Deviation Category
text
C1705236 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Code List
Deviation Category
CL Item
Consent Deviation (1)
CL Item
Drug/Device Administration Deviation (2)
CL Item
Enrollment Deviation (3)
CL Item
Procedural Deviation (4)
Effect on Patient Care
Item
Effect on Patient Care
text
C0017313 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
Action Taken
Item
Action Taken
text
C0441472 (UMLS CUI [1])
Item
Report to the IRB
text
C0684224 (UMLS CUI [1,1])
C0086911 (UMLS CUI [1,2])
Code List
Report to the IRB
CL Item
Not applicable (i.e. does not meet Reportable Event criteria) (2)
Date Reported to the IRB
Item
Date Reported to the IRB
date
C0011008 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0086911 (UMLS CUI [1,3])
Principal Investigator Signature
Item
Principal Investigator Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])