Item
Report to the IRB
text
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
AE Description/Details
Item
AE Description/Details
text
Category
Item
Category
text
CL Item
Life Threatening (4)
CL Item
Death (Fatal) (5)
Unexpected
Item
Unexpected?
boolean
Item
Dose Limiting Toxicity (DLT)
text
Code List
Dose Limiting Toxicity (DLT)
CL Item
Not Applicable (3)
CL Item
Dose Interrupted, then Reduced (2)
CL Item
Regimen Interrupted (4)
CL Item
Therapy discontinued (5)
CL Item
Not Applicable (leave blank) (6)
CL Item
Vigorous Supportive (4)
Item
Protocol Attribution
text
Code List
Protocol Attribution
Item
Detailed Attribution
text
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
Specification
Item
If Investigational Treatment, please specify
text
Specification
Item
If Non-Investigational Treatment, please specify
text
Specification
Item
If Other, please specify
text
Principal Investigator Signature
Item
Principal Investigator Signature
text