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OnCore for Non-Cancer

OnCore is Stanford’s secure centralized system for tracking clinical research. As required by School of Medicine policy, all clinical research involving consent under Stanford purview, even if no participant signature is required (IRB has given a “waiver of documentation”, e.g., for info sheet or online survey) must be registered and record accrual 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.

Questions?

Email: OnCore Help Desk

Phone: (650)724-4763

On This Page

  • OnCore Access
  • Required Steps: REGISTER | TRACK ACCRUAL | MAINTAIN STUDY
  • Beyond the Basics: Additional Features
  • Additional Resources
     

OnCore Access and Training

Completion of OnCore Basics for Non-Cancer training is required to activate an OnCore login. These options are available:

  1. Sign up for an Zoom webinar training session (~2 hours, no prior OnCore experience)
  2. Sign up for web-based online learning (self-paced, no prior OnCore experience)
  3. 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.

REGISTER

Step 1Submit a Study Registration Request through the OnCore Request Portal

OR

If your department is using OnCore ePRMS to manage their CRU (Clinical Research Unit), refer to OnCore ePRMS Submission instructions

Step 2Complete the protocol set-up using the instructions or quick reference card provided in the email you receive when your study has been registered in OnCore, or approved by your CRU

TRACK ACCRUAL

Step 3When ready to begin enrolling participants, submit an Open to Accrual Request through the OnCore Request Portal

Step 4Track accrual using either the Per-Participant method or Summary Accrual Only option. Learn more about the differences between these two options.

MAINTAIN STUDY

Step 5When the study is Closed to Accrual, submit a Study Change Request to update the study status in OnCore using the OnCore Request Portal

Step 6Submit 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.
 

Feature

Benefit

Instructions

Tracking Consent

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

Workflow graphic

Step-by-step instructions

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.

Participant Bulk Load Service

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

Effort Tracking Quick Guide

Contact the OnCore Support Team if your division is interested in using this feature.

Additional Resources

Video and Document Libraries

Informational videos, forms, training materials, guides and more related to the OnCore system.

OnCore Newsletter

Get the latest relevant news and reminders on the OnCore program.

OnCore Slack Channel

Join the Slack channel to get the latest updates.

#oncore-mz-noncancer