Complion eRegulatory Binders
Complion is a cloud-based eRegulatory platform that improves the efficiency of maintaining regulatory documents for all types of human subjects research. Complion is used by research sites and universities nationwide and is 21 CFR Part 11 compliant. Northwestern partnered with Complion in summer 2021 to launch with select departments and will continue to expand. To learn more about the platform, watch this video.
Individual study team members and investigators can only access Complion through their department or center. If you are a clinical research coordinator (CRC), regulatory coordinator, research assistant, faculty investigator/sub-investigator or research nurse, please contact your research operations manager or research administrator about Complion access.
If you are a research operations manager or administrator and want to get Complion access for your department or center, please contact navigator@northwestern.edu. A NUCATS representative will work with a department point person on an implementation plan, including possible live training sessions with Complion.
Training
Required Training
Federal regulations require that each person accessing the platform complete training for their specific regulatory responsibilities. The required trainings are built into the program, and new users will automatically be directed to these when they first log in to the platform. Staff and faculty will not be able to use any functionality of the Complion platform until the required training is complete. After the built-in training is complete, no further action is required. For larger departments, a live training session during the rollout process may take the place of the built-in required training modules.
Optional On-Demand Training
On-demand eLearning modules on additional functionalities of the Complion platform can be accessed through myHR Learn via the user-specific links below (netID required). Completion certificates can be added to professional development plans or be submitted as continuing education documentation (where permitted).
- Training for Study Team Members (e.g., CRCs, research assistants, research nurses)
- Training for Investigators (those who will be approving forms/documents for their study, including sub-investigators)
- Training for Complion Administrators (typically an operations manager, chief project manager or research administrator who will set permissions for their department)
Ongoing Support & Job Aid Library
Anyone with an activated Complion account can visit Complion's training website for an extensive library of videos, click-by-click guides and job aids.
Policy
Complion is required for FDA-regulated studies and those that are multi-site. For more information, you can find the Feinberg policy here.
NOTE: You must be on campus or VPN to access the policy.