OnCore Clinical Trials Management System (CTMS)

OnCore is the Clinical Trials Management System (CTMS) used at University of Oklahoma Health Sciences Center. It provides a centralized, comprehensive system for managing the full life cycle of a clinical trial. OnCore is a secure, web-based application and is compliant with all applicable laws and regulations.

Functionality

• Protocol Management 

  • Define staff roles; record sponsor information, treatment and disease details, participating institutions, study sites, and affiliates; document committee reviews; store consent forms; and perform general task management.

• Subject Administration

  • Registration, eligibility verification, enrollment documentation, and status management.

• Biospecimen Management

  • Record collection details, management of specimen inventory, tracking banking and correlative protocols, and designation of parent/child specimens.

• Financial Management

  • Centralized storage of the research charge master, budget creation, sponsor invoicing, receipt tracking, and payment reconciliation.

• Subject Administration

  • Registration, eligibility verification, enrollment documentation, and status management.

• Protection of subjects
• Facilitation of remote monitoring
• Improved compliance
• Streamlined research data management
• Standardized user training
• Accurate institutional metrics
• Custom reporting features
• Access logs and audit trails
• Efficient program and resource management
• Centralized research portfolio
• Integration with Epic for subject management
• Integration with Vestigo for investigational drug management

We are also in the process of building integration frameworks between iRIS and OnCore, as well as expanding the integration between OnCore and Epic.

At this time, all studies meeting any of the following criteria must maintain their study protocol and patient tracking in OnCore. 

• Study includes a billable component, irrespective of the party responsible for the charges 
• Study involves Investigational drug or device 
• Study includes performance of procedures at an OU Health facility, such as a lab or radiology service 
• Study involves research-only visits in a clinical setting

As a rule of thumb, if anything in your study’s IRB protocol will require use of Epic (for anything other than for retrospective chart review or registry creation/updates), you should use OnCore for study management. 

Whoever will be entering data into OnCore, and those who may use OnCore to monitor study details need access. Most frequent users of OnCore include Research Coordinators and Research Nurses.  

Studies should have sufficient staff to do the following:

1. Create and maintain study protocols
2. Add and update IRB reviews, as needed
3. Create calendars, add procedures associated with study visit timeline
4. Modify coverage analysis to designate which study-associated procedures should be bill to insurance vs. bill to research (or not billable).
5. Manage subjects including: 
   • Registration
   • Documenting consent, eligibility, on study, on treatment, on follow-up dates
   • Document study visits after they have occurred and which procedures occurred during that visit 
6. Optionally: generate invoices to sponsor using charges and visits documented in OnCore.

Frequent users of OnCore typically include Research Coordinators and Research Nurses. Some teams also include staff who work on financials, including invoicing, coverage analysis, etc. 

Study teams are not typically required to obtain OnCore training and access for all Key Study Personnel (KSP).

To request OnCore access for new users, contact Thomas-Wilson@ouhsc.edu cc: CTMS-Support@ouhsc.edu to request a training. 

After you have attended, training, a user account will be created with you. When an initial user account is created, the user will receive a set-up email from the OnCore system. This email will contain an activation link.

Click the activation link in the email. Log in using the username and password associated with your OUHSC Network ID.  Please note, the OnCore system administrators will not be able to provide password assistance. 

The activation link will work for 24-hours. After that, a new activation link will need to be generated by an OnCore System Administrator (email CTMS-Support@ouhsc.edu) . Note: The activation link may only be used once.

You will be given access to both the training and production instances of OnCore once you have completed training.  After activation, you may access OnCore at the following links:

Training: https://ouhsc-oncore-train.advarra.app/

• Use OnCore Training instance to practice navigation. You can create fake studies and perform most of the functions as in Production

Production: https://ouhsc-oncore-prod.advarra.app/

• Please only use real data in this environment

Visit our training resources page

For general questions or concerns related to OnCore, please email the CTMS support team at ctms-support@ouhsc.edu.  

For Oncology workflow or study-specific questions, please contact sccsystems@ouhsc.edu. 

Note: please do not include PHI in the communication. 

• ​​​​​Enter the subject's consent in OnCore on the same day they consent, when possible. A subject's consented status is what triggers the patient's account for billing review, and as long as they are consented on or before the date of service, they will be reviewed.
• Enter study/participant visits recorded in Epic into OnCore within 1 business day of occurrence. 
• The billing review team will typically review these charges within 1-2 business days of the service to ensure prompt processing. 
• The dates of service should match the dates entered in OnCore. 
• Complete a Specification/Calendar and update the billing grid in OnCore. 
• Even if all activities associated with the study are routine or fall under the "standard of care" and are billable to the patient or insurance, the research billing team must be able to easily identify charges related to the study and apply the appropriate modifier (e.g., 'Q0', 'Q1', or adding NCT# to claims).
• If any charges are to be billed to a sponsor, this should be reflected in OnCore based on the date of service. Appropriate places to note charge routing are in the coverage analysis, billing grid, or billing notes. Failure to accurately designate charges that should be billed to the sponsor can lead to improper billing of the patient or duplication of charges (i.e., fraudulent charges). 
• Respond promptly to inquiries from the OUH Research Billing Review team regarding visits or patient encounter activities. 

Contacts for research billing and compliance: 

​​For full instructions, please refer to the OUHSC OnCore Quick Guide for Non-Oncology studies .  

Adding a new study to Epic

Once your study is ready (review the quick guide for all steps that should be completed prior to pushing your protocol), and the protocol status is open to accrual (or any status other than 'NEW'), and all staff are listed in the appropriate roles, you must: 

1. Email the OnCore administrator (CTMS-Support@ouhsc.edu) to alert them that your study is ready to push to Epic. This is a manual process; and if you skip this step, it will delay your study activation.
2. Fill out the study activation questionnaire (follow the link on the homepage in OnCore). 

The Epic research analysts will use this information to activate your study in Epic. This will typically take 1-2 business days. 

Modifying study protocol details, adding personnel

If you add new personnel or modify other study details, such as calendar changes, arms, etc., they will sent over with the weekly push to Epic (typically on Friday). If you need changes to show up sooner, contact the OnCore administrator and request that the study be pushed to Epic again (include protocol number). 

Removing personnel

If you remove personnel or put a stop date in OnCore, this does NOT push to Epic. To remove study personnel in Epic, you should put in a ServiceNow request. 

Modifying other study profile details that aren't sent from OnCore (e.g., study contact)

Submit a ServiceNow request.

Troubleshooting: 

A member of my study team is not able to link orders/encounters/etc. to the study or does not have the expected access to the study in Epic: 

1. Verify the study team member is added to the protocol in OnCore in the correct role. 
2. If they are listed in the correct role, contact the OnCore administrator. We may need to add information to their contact to allow studies to "link" to that person.

1. Add a stop date for that personnel member in OnCore.
2. Put in a ServiceNow ticket to request they be removed from study personnel in Epic (OnCore pushes new team members added, but not those removed/with a stop date). 

• Protocol data
• Subject data

Protocol Data

The following table shows which portions of a protocol are pushed from OnCore to Epic:

Additional information about the study, including study contact and details about billing, any links you would like included, automated actions (if PI should receive results In Basket), etc. are added from the Research Study Activation Questionnaire that is filled out by study teams when the study is pushed the first time. 

Subject Data

Subject Management

Problem: When I try to register my subject, I can't select a study site.

Fix: Go to PC Console > Institutions > click the institution name > Study Sites, and make sure at least one study site is checked (Update, check appropriate box(es)). 

Problem: I have successfully registered subjects previously, but I have a subject that is not appearing when I search their MRN to register.

Fix: If this patient is a VIP or has an otherwise restricted record, they will not be able to automatically pull from Epic. Email CTMS-Support@Ouhsc.edu with details, and we can manually add their record.

Problem: I've registered my subject, but I'm getting an error when trying to add a consent form

Fix: Check the following: 

• PC Console > Reviews > IRB -- each IRB review should include at least one consent version. If not, click 'Edit' and add a consent to the review. 
• The consent you're trying to add might be in the wrong date range. If the subject was consented prior to the most recent continuing review, click the plus ('+') sign next to the consent name to pull up different versions of the consent, and choose one in a valid date range for the consent date.

Study Management

Problem: My study is activated in Epic, but I am not able to access it or add patients to it.

Fix:  1. Verify all parties who need to access the study in Epic are added in a relevant role (e.g., Principal Investigator, Research Coordinator, Research Nurse, etc.).

0. 1. If person without access is listed on that study in an appropriate role, contact CTMS-Support@Ouhsc.edu with the protocol number and staff member.
1. If not, add the person with the appropriate role (note: Protocol Creator is not a role that pushes to Epic), and email CTMS-Support@ouhsc.edu with the protocol number, and request that the study be re-pushed to Epic. (All studies are pushed with updates on Fridays, so if the need is not immediate contacting us is not necessary.)

Specifications/Calendars

Problem: I have created a calendar, but I can’t access it on the Subject Console.

Fix: If your calendar is ready, go to Menu > Forms/Calendars > Specifications > Protocol Specifications and select the protocol number for the study in question. Click “Calendar”, and select arm(s) from the dropdown box. If the calendar is still in new/unreleased status, click the “Complete” button and then the “Release” button. This releases the calendar for use with subjects.

If you need a new version of the calendar after it has been attached to subjects, follow the same procedure, and instead of “Complete” or “Release”, there should be a “New Version” button. When that version is ready, you can also complete and release it.  If you wish to change existing subjects to the new version of the calendar, you can either change this on their individual Subject Console > Calendar or change many/all at once using the CRA Console.