Clinical Trials Office Monitors & Auditors

At this time, our site is only allowing on-site monitoring for mission-critical studies and mandatory inpatient studies due to space limitations and covid restrictions. All other monitoring visits will continue to be scheduled remotely until deemed on-site necessary by CTO Data Leadership.

Additionally, we have launched a new eRegulatory system that allows us to provide source documentation and the regulatory documents via the same portal, which is 21 CFR Part 11 compliant (validation documents available upon request.)

Please note that monitors do not get access to our EMR while on-site, as on-site time is reserved for paper chart review only.

System Access Forms

Please follow the steps below to request access to the systems and tools needed during your visit. The Data Specialist for your trial will be happy to assist in coordinating your visit to the Stephenson Cancer Center. Please read the options below to complete the appropriate forms for your visit.

Remote or On-Site Monitoring Visit

All monitors scheduling with SCC will need to complete the electronic Monitor Access Form. Please complete the below link depending on what phase you will be monitoring at SCC.

• Early Phase (Phase 1)
  • https://redcap.link/4csgfkcw
• Late Phase (Phase 2-3)
  • https://redcap.link/gt74aw9c

Our Data Specialist Team will review your information. Once details have been verified, you will receive an email confirmation with the details of your visit.

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

Please note that you will be responsible for remembering your network passwords and log-in information for SCC Systems. For security purposes, our staff will not have access to your passwords. Please note that OUHSC campus IT will need to reset any forgotten passwords, which may cause time delays.

On-Site Visits
Parking Instructions
Monitors may park in the Harold Hamm Diabetes Center Parking Lot. A Daypass 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. Remember, the parking location for Monitors is the Harold Hamm Diabetes Center Lot, located on the West side of the Cancer Center.

If you have questions regarding on campus parking, or if you receive a parking citation, please contact the parking office: OUHSC Parking Office, Research Park 825, First Floor #115, P: 405-271-2020, Hours of Operation: 7:30 am – 5 pm, Monday - Friday

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

Please take the elevators to the 6th floor and email your data specialist contact when you arrive. The data specialist will walk you to your assigned monitoring location, where you will receive your monitoring badge and sign in to begin monitoring.

All study-specific conversations must occur via email. However, if you must discuss something in person, please alert your Data Manager, and they will schedule a conference room.

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