Projects & Collaborations
Indiana University and IU Health are currently rolling out OnCore in conjunction with Cerner PowerTrials among different departments, divisions and research groups. OnCore is a new addition to the support provided under the Indiana University Clinical Trials Office (CTO) and was selected as the tool to assist us in meeting our objectives:
1) Promoting patient safety,
2) Facilitating recruitment, and
3) Enhancing efficiency and effectiveness of managing clinical trials across the research enterprise.
The first phase of implementation includes entry of basic protocol and subject information according to the minimum standardized requirements. Please contact the OnCore support team for more details.
Phase 1 Implementation Timeline
What is PowerTrials?
PowerTrials is an application within Cerner. It is IU Health’s electronic medical record that enables transparency between clinical research and clinical care.
Key Attributes of PowerTrials:
- Indicates that a patient is a subject on a clinical study by flagging them in the demographic (banner) bar of the electronic medical record.
- Provides basic protocol and study contact information to all IU Health clinicians.
- Notifies the study contact when a study participant is registered for an inpatient, outpatient or emergency visit at an IU Health facility.
- Allows for subject recruitment from the IU Health patient population using screening tools built around the inclusion/exclusion criteria for a study (future functionality).
How do I get access to Cerner?
Access request forms can be found under the IU Health Records Request header on the Forms and Templates page of the Office of Research Compliance website.
Where can I receive training on Cerner applications used by the research community?
What other documentation is available for Cerner PowerTrials?
Requirements for VA Protocols – FAQ’s
- I am managing an IU IRB approved or IU IRB Deferred study that is ONLY being conducted at the VA.
QUESTION: Does it need to be entered in OnCore?
ANSWER: Yes, if ALL the following criteria are met!
- OnCore Registration Requirements are met.*
- The PI/VA investigator has an IU paid appointment is utilizing the IU paid appointment on this study.
- Research has been approved by VA R&DC
- The VA ISO/PO Checklist, VA HIPAA Authorization and VA Informed Consent describe disclosure of the VA subject’s data to Indiana University.
- I am managing a study that is being conducted at both the VA and a non-VA study site.
QUESTION: Does it need to be entered in OnCore?
ANSWER: Yes, as long as OnCore Registration Requirements* are met AND all VA documentation (VA consent, VA HIPAA, ISO/PO checklist) is consistent in describing disclosure of the VA subject’s data to Indiana University.
- My study is eligible for individual patient registration per #1 or #2 above.
However, the VA will not allow VA MRN’s to be input in OnCore.
QUESTION: What to do?
ANSWER: Veteran’s SSN’s will not be entered in OnCore. Instead, subject identifiers unique to the system should be created. Typically, we use a short name/number for the study followed by the patient’s enrollment ID (i.e. VA-BETA-101, VA-BETA-102, ect…). Please note that the ISO/PO checklist, VA HIPPA authorization, and VA consent must state that data will go to the entity IU.
- QUESTION: Under what conditions can I enter a Summary of Accrual rather than individual patient registrations?
ANSWER: Studies that include an Expedited IRB review OR are only being conducted at the VA are eligible for Summary Accrual Only. All other VA studies should include individual patient registrations.
* OnCore Requirements:
A prospective, clinical study (includes interventional, observational & Expanded access / compassionate use) with use of an informed consent.
The ISO PO Checklist refers to the PI’s documentation for VA security & privacy requirements. The document is found on the IU IRB forms page & is called: ”Privacy, Confidentiality & Information Security Source Checklist for Research”.
IU IRB Forms page: http://researchcompliance.iu.edu/hso/hs_forms.html
Contact the RLR VA Research Administration regarding VA R&DC approval prior to opening a study with the IU IRB:
Standard Pricing Schedule for Industry Sponsored Clinical Research Studies:
A schedule of recommended fees for industry funded clinical research studies is available to Indiana University School of Medicine and Indiana University Health researchers.
The fee schedule serves as guidance to assist in the development of budgets for industry funded clinical research studies by:
- Providing a consistent starting point for budget negotiations with sponsors.
- Ensuring research teams more accurately estimate time/resources required for research activities.
- Offering a fee schedule to develop a budget based on study complexity.
- Promoting transparency of research related costs for industry sponsors.
- Facilitating budget preparation as the current version of standard fees will be available in the OnCore® CTMS Charge Master or from the CTO.
For more information – please contact the Indiana University Clinical Trials Office at firstname.lastname@example.org or 317-278-2546.
During the budget construction phase of clinical study initiation, a documented analysis of cost allocation must be completed. This coverage analysis is a systematic review of clinical trial documents to determine the costs of conducting the trial and assigning billable services and procedures to the sponsor, third party payer or patient/subject. It is the responsibility of the Principal Investigator (PI) to ensure that clinical services associated with research studies are billed appropriately. The analysis includes:
- Qualifying trial determination: Medicare Coverage Analysis (MCA) for drug studies
- CMS determination documentation for device studies
- Supplemental Coverage Review by the Medicare contractor Medical Director or Fiscal Intermediary for services for which coverage is not yet established
- Review of cost allocation language in all study documents for consistency
OnCore can be used as a tool to assist you with your Coverage Analysis needs. It includes a checklist to help you determine and document that your study is a Qualifying Clinical Trial (QCT) according to Medicare rules. It can also record billing information for each procedure listed in the protocol and provide you with a Billing Grid that includes a calendar view of all scheduled procedures and their respective billing designations. Check out our OnCore Learning Manuals, Tools, Tips and FAQ’s for additional information on the Coverage Analysis Console of OnCore.