Here are the steps you can take to ensure you are as prepared as possible for on-site reviews/assessments:
For Human Research Protocol Reviews:
Ensure that all research team members are aware of the upcoming QA/QI Review. Not all personnel will be required to take part in the review, but it is recommended that the PI be present.
Download the Self-Administered Best Practice Review document and walk through it in regards to your protocol. This will help identify any gaps in your protocol management so you can address them before the on-site review.
Download and review the Documentation Checklist to ensure that necessary documents will be available and accessible during the review in hard copy and/or electronic format.
Contact the QA/QI office with any questions/concerns you have about the visit.
Relax! You are a research professional and have confidence in your work. This review is a snapshot of your protocol intended to help confirm and even improve your already high performing research practice.
Expect the following 5 areas your protocol to be reviewed during the on-site review visit:
The Consent Process
Personnel and Proper Training
For TCP Assessments:
Review your TCP and its implementation on your research project. If anything has changed since the TCP was written/last updated (personnel, data management, etc.) please contact the Office of Export Controls immediately to udpate your TCP.
Ensure that all research team members are aware of the upcoming Assessment and review the active TCP with them.
Be prepared to answer questions about your TCP and show the assessment conductors all TCP addressed cybersecurity and physical security perameters within the location of where the controlled research is being conducted.
Contact the QA/QI office with any questions and communicated your concerns about the visit.