CATS IRB Upgrade:

FDA General Inspection:

Not for cause
Did sampling and asked questions about reliance and reporting out to federal agencies
Here for one week and had no findings.

Minor increase in turnaround times which includes CATS IRB upgrade and staff transitions
New hires joining the team soon

Advisory Committees: faculty and administrators
- Where to find members of each committee
- Role of Committees are to gather feedback, identy concerns, future goals, and assess progress toward goals
  - How to contact Advisory Committees or HRPP in order to share feedback
PRC Memos - internal communication. Clarification:
- PRC approval will begin its review while HRPP application is being processed
- HRPP must have PRC memo before final approval can be issued
- Should PRC request changes to protocol, then HRPP must review changes before final approval
HRPP CATS IRB - instances of finalized documents by mistake
- Train staff accordingly. They do have information internally about what documents need to be finalized
- There is no process to reverse finalized documents
- Please double check to be sure your team has the correct version of your materials, specifically consent forms

Website dedicated to closing studies.
Submit a CR to the system to close a study.
- Click the first four milestones
- Then click the second box acknowledging the completion of a study.
- This will close the study
- Only PI or PI proxy can submit a study closure