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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-107 SOP Title: Reportable Events
IRB Contact Information:
http://www.utsouthwestern.edu/research/research-administration/irb/index.html Phone: 214-648-3060
Fax: 214-648-2171
6. PROCEDURE PROCESS MAP
D020
Gather information on AE / SAE from subject & health care center (treating)
Confirm Study Information
Determine type of event and reporting guidelines as outlined by IRB of record
Select Reportable Event Type
Report AE / SAE to PI and Sponsor. Provide supporting documentation
Complete Reportable Event documentation
Does Reportable event need to be
Report to IRB of record.
Login to eIRB
Click Reportabl e Event Tab
Click New Reportabl e Event Tab
reported to the YES IRB of record?
Click Finish
Notify PI to review and submit
Review / Advise Treatment Plan and request supporting information
Review and Submit Reportable Event
Review AE / SAE,
Request additional Make Acknowledge
information as recommendations Reportable Event needed
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
Page 8 of 8
IRB PI / Sponsor CRC / CRA
Start
Finish