OnCore for NON-CANCER
OnCore is Stanford’s secure centralized system for tracking clinical research. As required by School of Medicine policy, studies that consent human subjects with a Stanford consent form, or consent/information sheet with a waiver of documentation, must be registered and have their accrual recorded in OnCore.
|Read the School of Medicine Policy for Using OnCore, watch this brief video, and refer to our Frequently Asked Questions to learn more.|
Completion of the OnCore Basics for Non-Cancer training is required. See upcoming training sessions and sign up through STARS. If you are faculty or previously used OnCore, contact the OnCore Support Team to learn about other training options.
Since OnCore contains Protected Health Information (PHI), researchers and other OnCore users must have and maintain current HIPAA and human subjects protections training prior to requesting OnCore access, and for the duration of their OnCore use.
Working off campus? You must connect to the Stanford Network through Cisco AnyConnect VPN before accessing the OnCore site. For help, contact TDS.
Required Steps: Register | Track Accrual | Maintain Study
At a minimum, the steps below must be completed for studies that meet criteria for OnCore registration. Other studies can also be registered even if there’s no requirement to do so.
Complete the protocol set-up using the instructions provided in the e-mail you receive when your study has been registered in OnCore, or approved by your CRU
When ready to begin enrolling participants, submit an Open to Accrual Request through the OnCore Request Portal
Track accrual using either the Per-Participant method or Summary Accrual Only option
Note: When using the Per-Participant method, at a minimum, participating subjects must be 1.) registered and 2.) placed On Study as described in the Subject Management Guide
When the study is Closed to Accrual, submit a Study Change Request to update the study status in OnCore using the OnCore Request Portal
Submit a Study Change Request for IRB Study Closure using the OnCore Request Portal once your study is Closed in eProtocol
Remember to use the OnCore Request Portal for:
- other changes to a protocol's status (abandoned, suspended, etc.).
- changes to protocol staff.
- deleting/merging participant records.
Beyond the Basics: Additional Features
These features are not required but can help teams streamline processes and work more efficiently.
|Keep track of when participants consent, and on which consents forms and versions.||Subject Management Guide|
Assessing Subject Eligibility
Easily track how many participants you’ve assessed and the percentage that were eligible/ineligible.
Set up automated Eligibility Questionnaire in OnCore
|Subject Management Guide|
Pre-Consent Screening & Eligibility Tracking
Readily determine how many people were screened to reach target enrollment. Find the most common reasons people were ineligible.
*Requires IRB Waiver of HIPAA Authorization
|Contact the OnCore Support Team if interested in using this feature, then enroll to see a brief video to learn more and complete the training.|
|Recording AEs, SAEs, & Deviations||Quickly pull reports that can be used e.g., at IRB continuing review.||AEs, SAEs & Deviations Video|
|Effort Tracking||Demonstrate time devoted to different study tasks to better understand and improve processes related to budgeting, workload management, and sponsor negotiations.
||Effort Tracking Video. Contact the OnCore Support Team if your division is interested in using this feature.|