OnCore Clinical Trials Management System (CTMS)

The Research Electronic Data Capture (REDCap) system and REDCap Survey are powerful software programs created by Vanderbilt University and supported by the REDCap Consortium to facilitate Institutional Review Board (IRB)-approved clinical research and basic research. Data collected in the course of the research are managed by the program, and can be analyzed by commonly used statistical packages, including SAS, Stata, SPSS, and R.

REDCap is a browser-based, metadata-driven electronic data capture software created by Vanderbilt University. The REDCap Consortium is composed of nearly 900 active institutional partners from more than 70 countries. Programming, networking or database experience is not needed to use REDCap. It is designed to use simple interfaces that handle these details automatically. REDCap is secure and web-based: you can input data or build an online survey or database from anywhere in the world over a secure web connection with authentication and data logging. REDCap allows multi-site access for research that uses multiples sites and institutions. OUHSC maintains three instances of REDCap: the Biomedical and Behavior Methodology Core Customization Instance , the Enterprise Instance, and the Development Instance.

The REDCap system provides functionality and features to enable researchers to rapidly develop databases and online surveys. These databases, data entry forms, and surveys are intuitive, easy to use tools for collecting data, including data validation.

The design, use, and maintenance of REDCap are managed by the Biomedical and Behavioral Methodology Core (BBMC). The BBMC supports and enhances study design, data capture, and analytics for Pediatrics research.

REDCap has a flexible and fine-grained authorization matrix, allowing different members of the study team to have different levels of access (none, read-only or edit) to data entry forms, and access to database management and data export tools. There are provisions to restrict access to data export to allow export of de-identified data only. Advanced features of the system include branching logic for dynamic data entry form generation, file uploading, data importing, and embedded calculated database fields.

REDCap enforces authorization granted to each user by providing and/or enabling certain functions, tabs, links and buttons according to granted privileges.

REDCap includes a full audit trail, recording all operations on the data, including viewing and exporting. The audit log records operation, date and time, and the user performing the operation, permitting review of the audit trail as necessary.

REDCap enforces data integrity protection by design; all “databases” created by users are logical data sets on top of a relational database with built-in integrity protection controls. Additionally, REDCap can help to ensure data quality through use of Double Data Entry mode, forms and records locking and electronic signatures.

• 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. 

Non-Oncology Research Users: To request a new user account or to request additional permissions for an existing user, please submit an OnCore User Account Request form. 

• This may be filled out by the user or by another member of their team.
• Please indicate all roles to be added (e.g., Protocol Management, Subject Management, Financials, etc.). Your responses will be used to assign courses that must be completed in OnPoint prior to the permission being applied. 
• New user accounts will not be created until completion of the 'Basics of OnCore' curriculum, and limited access will be granted if other trainings are not completed. 
• Once a new user account is created, the user should receive 2 set-up emails with an activation link from the OnCore system, 1 for the OnCore training environment (for use with practice navigation, creating fake studies, etc.) and 1 for the OnCore production environment (please only use real data in this environment). 
  • The activation link will work for 24 hours. Users can log in with their OUHSC or OU Health credentials. If you do not activate within 24 hours, please reply to the ticket email to request a new activation link. Note: OnCore administrators will not be able to provide password assistance.
• When possible, we will complete account creation and role updates within 3-5 business days. If you have not heard back or need your request expedited, please reply to the ticket to indicate trainings have been completed.

Adding a new study to Epic

Once your study is ready (review the checklist below for the minimum components that  should be in your protocol prior to pushing to Epic),  you must fill out the OUHSC/OU Health Research Study Activation Questionnaire.  An Epic research analysts will use this information to activate your study in Epic. This is typically done on Fridays. If you need your study's activation in Epic expedited, please put in a ServiceNow request with OU Health IT (routed to Epic Research). 

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.

Checklist in OnCore before Pushing to Epic

•  Staff

  PC Console > Main > Staff:

  • The staff list must be maintained with any key personnel changes with IRB in iRIS.
  • Staff to be added to OnCore include those key study personnel who will need to access the study either directly in OnCore or in Epic.

•  NCT Number

  PC Console > Main > Details

  • If this study has an NCT #, it must be added prior to sending to Epic.

•  IRB Number

  PC Console > Main > Details

•  Institution & Study Site

  PC Console > Institution

  • Update to add OUHSC and any other relevant study sites.
  • Be sure to click the hyperlink for the institution(s) and select all relevant study sites. (If you are unable to register a subject, because there is no site showin gup under registration, this is likely missing).

•  IRB Review information

  PC Console > Reviews > IRB

  • IRB Initial Approval must be entered, and this will enable protocol status updates. (If your protocol status is "NEW", this step has not been completed.) A protocol cannot be pushed to Epic without an initial approval documented.
  • IRB Continuing Reviews must be entered when relevant.
  • Major modifications including changes to the protocol or consent must be included.

•  Protocol Status

  PC Console > Status

  • If relevant, open your study to accrual.
  • This should be updated as relevant (suspended accruals, study closure, etc.)

•  IDE #

  PC Conosole > Main > IND/IDE

  • If relevant, the Investigation Device Exception number should be entered in OnCore.

•  Specifications

  Forms/Calendars > Specifications

  • All studies that will have a billable component (anything in your protocol drops a charge) regardless of if it is paid for by insurance or by study must have an accurate calendar built in OnCore with charges designated appropriately on Coverage Analysis.
  • Non-Oncology users who need assistance building a calendar should reach out to CTMS-Support@ouhsc.edu to request support.

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.

What do I do if a study member leaves?

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

• Complete a Specification/Calendar and update the billing grid in OnCore.  page. 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.
• Document subject visits as having occurred in the Subject Console calendar within 1 business day of occurrence.
• Please note 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. 
• 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 and the billing grid. 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. 

Please refer to OnCore Training Resources page for additional details on Subject Management (documenting visits in OnCore) and Calendars/Specifications, and other tasks.

Please refer to the tip sheet in Epic for instructions on linking the encounter/order/service to the study (Hit F1 in Epic).

Contacts for research billing and compliance: 

Tamra-Gray@ouhsc.edu – Director, Office of Compliance– OUHSC 
Robin-Rhoades@ouhsc.edu – Healthcare Billing Compliance Manager -  OU Tulsa - School of Community Medicine
Michael-Webb@ouhealth.com – Senior Manager, Charge Review – OUH 

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).

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.

Problem: I need to register the same patient the second time for a new registration, but OnCore won’t let me

Fix: Go to PC Console > Management, and click the ‘Allow Duplicate Enrollment?’ checkbox to allow for multiple enrollments of the same patient.

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.).
2. 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.
3. 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.

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.  

For general questions or concerns related to OnCore, please email the CTMS support team at CTMS-support@ouhsc.edu.  This inbox is monitored by both oncology and non-oncology OnCore administrators and support staff. 

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

Note: please do not include PHI in the communication.