What's New at CPMC's IRBNew Reportable Events SOP
New Reportable Events SOP
The CPMC IRB has approved a NEW Reportable Events SOP:
Principal Investigators Reporting Requirements.
This SOP explains the types of events that need to be reported to the IRB and can be found in the “Forms and Templates” library in IRBNet.
In addition to the new SOP, the IRB also has four new forms and two revised forms.
- Unanticipated Problem Report
- Unanticipated Adverse Device Effect (UADE)
- Emergent Modification 5 Day Report
- Reportable Events Summary
- Adverse Events Report
- Protocol Violation Report
How to find the IRB Standard Operating Procedures & Forms in IRBNet:
Please login to www.irbnet.org.Opens new window with your username and password. Click “Forms and Templates” on your left hand menu for a listing of, and access to, the latest version of all available Standard Operating Procedures & Forms.
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