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.
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|
|Participant Bulk Load Service||
Many studies maintain participant enrollment information in other places, such as REDCap.
To reduce duplicate effort, we offer this service to upload and auto-register a list of participants to an OnCore protocol. This is for studies tracking individual participants in OnCore.
Contact the OnCore Support Team if interested in using this service.
|Effort Tracking||Demonstrate time devoted to different study tasks to better understand and improve processes related to budgeting, workload management, and sponsor negotiations.
Contact the OnCore Support Team if your division is interested in using this feature.