OnCore® Clinical Research Management System
for Non-Cancer Studies
SOM Policy for Using OnCore
Using OnCore for clinical research study tracking is required per School of Medicine Clinical Research Management Policy - Using OnCore POL-003.
Studies that consent human subjects using a Stanford consent form, or information sheet, are to register and record accrual in OnCore.
Common questions about OnCore
What is OnCore and why am I required to use it for my studies?
Clinical research management is a system of tools and processes that supports efficient research operation, facilitates compliance, and streamlines the flow of information, institutional tracking and oversight. The School of Medicine has now published "Clinical Research Management Policy: Using OnCore at Stanford," (POL-003, SUNet password required), explaining requirements for:
- Which Stanford studies need to be registered and tracked in OnCore
- Enrollment tracking
What studies am I required to register and track in OnCore?
Please refer to our Registration Criteria Reference Card and the Clinical Research Management Policy: Using OnCore at Stanford.
What studies should NOT be registered in OnCore?
Studies that meet the following criteria should not be registered in the CRMS, unless required by an individual department or clinical research organization.
- Projects identified by the Stanford IRB as Multiple Project Protocols (MPP).
- Veteran Affairs Palo Alto Health Care System studies approved by the Stanford IRB but that do not enroll (“consent”) participants at Stanford.
How do I get access to OnCore for non-cancer studies?
Completion of OnCore Basic Training for non-cancer studies is required for access to OnCore. Once the required training is completed, the OnCore Support Team will provide a user with an active login and password.
Because OnCore contains Protected Health Information (PHI), researchers and administrators must have and maintain current HIPAA and human subjects protections training prior to requesting a CRMS login account, and for the duration of their OnCore use.
What are my responsibilities related to OnCore as a clinical research coordinator on a study?
Register studies and keep them current and consistent with the approved IRB protocol version.
Track study accrual in OnCore.
Refer to the Clinical Research Management Policy: Using OnCore at Stanford for full information.
When and how do I submit a Study Registration Request?
OnCore study registration should be completed within 30 days of IRB approval, but may be done earlier – before or after submission to the IRB – according to local workflow, as determined by a department, center, or research institute. Study registration must be completed before participants can be added.
When your team is ready to register a study, submit a Study Registration request using our OnCore Request Portal.
When and how do I submit an Open-To-Accrual Request?
A protocol’s OnCore status must be changed to open-to-accrual before participants can be added.
Once you have completed the protocol set-up, the study has IRB approval, all funding/contracts are finalized, the study is registered with ClinicalTrials.gov (if applicable), and you are ready to begin enrollment, you will need to submit an Open to Accrual Request using OnCore Request Portal.
Registered studies must not be opened to accrual until:
- all agreements are completed with external partners, and
- any external funding awards are finalized by Stanford institutional representatives.
When should I report study changes to the OnCore Support Team and how?
If your study has been suspended, closed, abandoned, placed on hold, is now closed to accrual, or has been re-opened following previous suspension/closure, please submit a Study Change Request through our OnCore Request Portal.
Study close (no longer IRB approved): Submit a change request for IRB study closure through the OnCore Request Portal (Non-cancer studies) for studies where a Final Report Form is approved by the IRB, and for studies where our IRB does not require a Final Report Form but which remain ‘expired’ or have an administrative close when you know that the study is completed.
There have been staff changes for one of my team’s protocols, how should I report these changes?
We rely on the contact information we have for the PI and Clinical Research Coordinators listed on a protocol for times we need to reach out about an important question or update regarding the protocol. Please be sure to keep this information up-to-date and let us know of any staff changes by submitting a Protocol Staff Change request through our OnCore Request Portal.
When should I add participants to my protocol in OnCore?
Studies set up for per-participant accrual must register participants within five (5) business days of any informed consent process and mark accrued participants as “on study”, regardless of whether patient eligibility is being tracked in OnCore.
Studies set up for summary accrual must record participant accrual numbers at the end of every quarter after the study opens to accrual, to cover the following reporting periods. The summary report is expected within two (2) weeks of the end of the period.
a. January through March 31
b. April through June 30
c. July through September 30
d. October through December 31
How do I delete a participant from a protocol or merge a participant’s duplicate record?
If you have accidentally added a participant to a protocol or need to merge a participant’s duplicate records, submit at Delete/Merge Participant request through our OnCore Request Portal.
Why am I having trouble accessing OnCore?
In order to access OnCore, you must have an active OnCore login, a SUNet ID and password, and you must sign in using a computer registered to the Stanford Network.
If you are using a computer registered to the Stanford Network but are off-campus, you must connect to the Stanford Network through VPN before accessing the OnCore site:
- Set up a VPN client: Visit http://vpn.stanford.edu, and follow the instructions under Getting Started, then
- Set Up Two-Step Authentication: Follow these instructions to:
Contact the IRT Help Desk (650)-725-8000 if you need assistance.
I see that a Phase is required in the instructions for completing my protocol. What if a Phase is not applicable to my study?
The drop-down menu for Phase provides several options to choose from. One of these options is N/A. You can select this option if a phase is not applicable to your study. Always check with your study’s PI if you are unsure about which phase to select.
What if there isn’t an industry sponsor for the protocol I am completing?
A Sponsor must be included for every protocol added to OnCore. A Sponsor does not necessarily have to be an industry sponsor. For example, if funding for your study comes from Stanford, you can select: Stanford (Department Funding), Stanford (Gift Funding), or Stanford (Other Funding).
How do I add an affiliate (collaborating organization) to a protocol?
If you are the lead site and need to set up an affiliate (collaborating organization) for your study, please reach out to us at firstname.lastname@example.org and we can assist.
Affiliate organizations may also use our OnCore system for accrual tracking with the appropriate set-up. Contact your OnCore Support team for assistance.
What is the role of a Primary Clinical Research Coordinator’s (CRC) on a protocol?
The Primary Research Coordinator (CRC) for a protocol is generally the study team member who submits a study registration request, completes the protocol setup, requests that a protocol be opened to accrual, is responsible for adding and managing subjects, and reports study changes. There may also be additional backup coordinators who assist with these responsibilities. Completion of the OnCore Basics Training for non-cancer studies grants a user access to the Clinical Research Coordinator role in OnCore.
What trainings are available for OnCore for non-cancer studies at Stanford? How do I sign up?
The OnCore Basics Training for Non-Cancer studies is a required introduction to OnCore that focuses on the workflow and tasks for managing a study in OnCore. This in-person, hands-on class covers the basics of study registration and set-up, participant registration, and reporting. In this class, staff practice completing a protocol set-up and adding a subject to a protocol in OnCore.
Additional resource documents and training videos can be accessed on our website.
What if I’ve completed training to use OnCore for cancer studies? Do I still need to complete training for non-cancer studies?
There are different requirements for cancer studies and non-cancer studies registered in OnCore. If you’ve completed training for using OnCore for cancer studies and need to work on non-cancer studies as well, we offer online Zoom training (~1 hour) for staff who have received OnCore training previously. Please contact us directly at email@example.com to schedule a Zoom training session.
Staff with previous OnCore training for cancer studies are also welcome to sign up for our in-person, hands-on OnCore Basics Training.
If I’ve completed training but would like a refresher, can I take the training again?
Staff who have completed the in-person OnCore Basics for non-cancer training and are interested in taking the class again are welcome to register again. The OnCore Support Team also recommends our resources pages for resource materials and videos or contacting us directly for specific questions.
How is study information protected?
OnCore is hosted in the School of Medicine Data Center, a secure facility which monitors physical and virtual access and environmental conditions, and follows Stanford University IT server and application security standards as defined by the Information Security Office and the Privacy Office (see https://uit.stanford.edu/guide/securitystandards.)
Within the OnCore application, end-user access is controlled and restricted by a combination of access roles and privileges with associated scopes, implemented such that OnCore users’ use of protected health information (PHI) is limited to the minimum necessary to accomplish the intended purpose.
Does eProtocol information have to say my study is using OnCore?
The IRB is aware that OnCore is a clinical research management system in use at Stanford for many years, and does not require OnCore to be explicitly named in submissions to the IRB or in ICFs.
Does my study have to use OnCore for data capture?
We recommend study teams contact Data Science Resources to explore tools and options for data collection tools.
Does OnCore connect with CRISP?
CRISP remains the system for sponsor invoicing. Although there are plans for future streamlining, currently there is no sponsor invoicing done through OnCore, and no OnCore-to-CRISP connection.