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])
Item
Report to the IRB
text
C0684224 (UMLS CUI [1,1])
C0086911 (UMLS CUI [1,2])
Code List
Report to the IRB
CL Item
Next Continuing Review (2)
CL Item
Not Applicable (3)
Course start date
Item
Course start date (Enter date that course of treatment was initiated, if applicable)
date
C0750729 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
AE Description/Details
Item
AE Description/Details
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Category
Item
Category
text
C0683312 (UMLS CUI [1])
Item
Grade/Severity
text
C0441800 (UMLS CUI [1])
C0439793 (UMLS CUI [2])
CL Item
Life Threatening (4)
CL Item
Death (Fatal) (5)
Unexpected
Item
Unexpected?
boolean
C0877248 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
Item
Dose Limiting Toxicity (DLT)
text
C0013221 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
Code List
Dose Limiting Toxicity (DLT)
CL Item
Not Applicable (3)
Item
Action Taken
text
C2826626 (UMLS CUI [1])
CL Item
Dose Interrupted, then Reduced (2)
CL Item
Regimen Interrupted (4)
CL Item
Therapy discontinued (5)
CL Item
Not Applicable (leave blank) (6)
Item
Therapy
text
C0087111 (UMLS CUI [1])
CL Item
Vigorous Supportive (4)
Item
Protocol Attribution
text
C0596130 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Code List
Protocol Attribution
Item
Detailed Attribution
text
C0596130 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Code List
Detailed Attribution
CL Item
Disease/Condition (1)
CL Item
Investigational Treatment (2)
CL Item
Non-investigational Treatment (3)
Specification
Item
If Disease, please specify
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Investigational Treatment, please specify
text
C0949266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Non-Investigational Treatment, please specify
text
C0949266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Item
If Other, please specify
text
C2348235 (UMLS CUI [1])
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])