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.

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. Once the Data team receives and information has been reviewed, 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. The paper research charts only contain source documents that do not live in our EMR. On-site monitoring visits should be reserved for wet ink document verification only.

Request a Monitoring Visit

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 that for EPIC login issues, please select the forgot password link on the EPIC Care link.

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 Physicians Parking garage (P7). A day-pass parking permit must be displayed in the vehicle that is parked on campus. Please note this is a paid parking garage and validation is not available.

You will enter the garage from the main entrance, located off NE 10th Street, just past the traffic light at Phillips (directly across from the Stephenson Cancer Center). Please drive to the end of the garage and park near the overhead sign “Elevators to Williams Pavilion” on the southwest side of the parking garage.

From there, you will take the elevator to the first floor. You will enter through the double doors straight ahead, then take the first left. You will find Room 1240 is the second door on your left before you reach the restrooms.

On-site Monitor Check-In

Please follow the below steps on the day of your visit:

• Take the Williams Pavilion elevators to the 1^st floor. You will enter through the double doors straight ahead, then take the first left. You will find Room 1240 is the second door on your left before you reach the restrooms.
• You will check in with the suite 1240 staff, and the Oncology Data Specialist will walk you to your assigned monitoring location. This is where you will receive your monitoring badge and begin monitoring.
• 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 Tuesday – Friday, 9:00 a.m. – 4:00 p.m.
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.