Post Approval Action Guidance
Close an Active Protocol
Complete the
Protocol Closure Form, attach the form to the protocol in WVU+kc and submit
to the WVU IRB.
Protocol Status
Complete the
Protocol Status Form, attach the form to the protocol in WVU+kc and submit
to the WVU IRB.
Close or Re-Open Enrollment
Follow the
instructions to close or re-open a protocol to enrollment.
Continuing Review Cycles
Review the
information to determine the continuing review requirements for the protocol
type.
Major vs. Minor Amendments
Review the
information for the definition of a major\minor amendment and the requirements
for the protocol type.
Notify IRB
Follow the
instructions to submit a notification to the WVU IRB.
Post Approval
Review the
information for instructions on actions that are required after a protocol
has been approved by the WVU IRB.