Clinical Trials Office Monitors & Auditors

Due to space limitations, the OU Health Stephenson Cancer Center Clinical Trials Office (CTO) allows on-site monitoring in a hybrid model. The hybrid model includes remote monitoring before or after a scheduled onsite visit. The Stephenson Cancer Center CTO utilizes an eRegulatory system which is 21 CFR Part 11 compliant (validation documents available upon request), that allows us to provide source documentation and regulatory documents via the same portal, allowing for effective remote monitoring.

Request a Monitoring Visit

Remote or On-Site Monitoring Visit
All monitors scheduling with Stephenson Cancer Center must complete the electronic Monitor Visit Request Form to schedule a visit and obtain access to Stephenson Cancer Center CTO systems. Please complete the Monitor Visit Request Form and our Oncology Data Team will review your information. Once the information has been verified, you will receive an email confirmation with the details of your visit. Please note that on-site monitors will only be given access to paper research charts, therefore access to our EMR will not be granted for on-site monitoring visits.

Key Regulations
Please note: Monitors will be responsible for remembering passwords and log-in information for Stephenson Cancer Center Systems. For security purposes, CTO staff will not have access to your passwords.

Please note, for EMR login issues, OU Health Sciences Campus IT will need to reset any forgotten passwords.

For Advarra eRegulatory, the CTO Data Leads (SCC-CTO-DataLeads@ouhsc.edu) can assist with questions or access issues.

Instructions for On-Site Visits
Parking Instructions
Monitors may park in the OU Health Harold Hamm Diabetes Center Parking Lot (10B). A day-pass parking permit must be displayed in the vehicle that is parked on campus. Day-passes can be acquired online and printed, or you may purchase them in person from the parking office on the day of your visit.

If you have other questions regarding campus parking, or if you receive a parking citation, please contact the parking office:

OU Health Sciences Parking Office
840 Research Parkway, Suite 150
Oklahoma City, OK 73104
405-271-2020

Hours of Operation:
Monday – Friday
7:30 am – 5:00 pm

Monitor Check-In
Please follow the below steps on the day of your visit:

• Take the elevators to the 6th floor and email the assigned oncology data specialist when you arrive.
• The Oncology Data Specialist will walk you to your assigned monitoring location. This is where you will receive your monitoring badge and begin monitoring.
• Monitors will be solely responsible for remembering network passwords and log-in information for Stephenson Cancer Center Systems. Our CTO staff will not have access to monitor passwords. Please note that OU Health Sciences IT will need to reset any forgotten passwords, which may result in delays.
• All study-specific conversations must occur via email. However, if you must discuss something in person, please alert your assigned staff member, and they will work to schedule a private conference room.

For security purposes, Monitoring hours are 9:00 am – 4:00 pm.
These hours will be strictly enforced.

In case of inclement weather, the OU Health Sciences campus may adjust hours of operation. Please monitor your emails and check ouhsc.edu for changes to the hours of operation on campus.