What are Research Systems

• If a clinical research study conducted at Indiana University or IU Health includes a prospective component and provider services and/or requires informed consent, that study is required to be entered into OnCore.
• To determine whether your clinical study should be entered into Oncore, view the Decision Tree.

Documents our clinical research portfolio at IU and IU Health.

• This is the only centralized system available at IU that captures accrual information and protocol status as studies move through the study lifecycle (i.e., pending, active, closed).
• OnCore is used to assist with grants and bring in more research.
• OnCore data is utilized to report out on data from IUSOM and IU Health strategic goals.

Documents a coverage analysis review.

• This may or may not be a full coverage analysis.
• The review includes alignment of primary research documents.

Assists with patient safety.

• OnCore is integrated with Cerner to notify clinical staff of IU Health patients that are on study.
• Study team are also then alerted when study participants enter any IU Health facility.

Maintains Research Billing compliance.

• OnCore data is provided to IU Health Revenue Cycle Services (RCS) so bill holds can be placed on study participants for the duration of their study.
• RCS also reviews charges against the documented coverage analysis to help maintain billing compliance

Integrates with other research systems.

• OnCore integrates with Advarra Participant Payments which is Automated payment system used to efficiently manage stipends and travel reimbursements paid to participants across clinical studies.
• OnCore integrates with Advarra eRegulatory which is a 21 CFR part 11 compliant system for storage of essential protocol documents, staff credentials, and organizational regulatory documents.
• OnCore integrates with the IU IRB system, Kuali Protocols.
• OnCore integrates with iConnect which is a system designed to facilitate patient-recruitment and allow investigators to improve online awareness of their trials, communicate with interested participants, and monitor recruitment metrics.

Provides clinical research reporting

• Oncore is the only centralized source of information on the IU and IU Health clinical research portfolio.
• We provide data to leaders within IU, IU Health, CTSI, and other strategic research partners.
• Detailed data sets can be provided to individual departments, divisions, Principal Investigators, or study teams.
• Standard dashboards and graphics are created to help manage and provide oversight for studies at all levels.

• Access to Oncore can be requested on our website or directly using this link: https://redcap.link/OnCoreTrainingandAccessForm.
• Training is required for anyone who has access to modify data in the system.

• OCR Website
• Contact OCR Systems Support at oncore@iu.edu or 317-278-2600.

The Payments system is strongly recommended for all studies where subject stipends and/or reimbursements were previously provided in the form of gift/debit cards or cash.

• Web-based secure system approved for use by IU and IU Health.
• Participants are each provided a reloadable card that can be used across studies.
• Payments can be credited to the cards within 5 min.
• Streamlines the reimbursement process. Coordinators send reimbursement requests to finance for review, using built-in mileage calculations, and uploading receipts on the spot. Maximums for hotel, parking, and mileage can be set ahead of time.
• Proven to streamline the reimbursement process at IU.
• Keep track of finances with built-in reports. Track payment amounts across subjects and protocols with a variety of reports, including 1099s, itemized receipts, and sponsor invoicing, to meet financial and tax reporting needs.
• Monitor finances with increased security features. Ensure security and control over finances with masked social security numbers, first-time payment verification, and audit reports.

• Access to Participant Payments can be requested on our website or directly using this link: https://redcap.link/ParticipantPayments.
• Each employee who requests access to Payments must complete the designated training for the appropriate functional role(s) before access is granted.

• OCR Website
• Contact OCR Systems Support at oncore@iu.edu or 317-278-2600.

• The Advarra eReg system is recommended for all studies utilizing electronic storage of regulatory documentation and essential protocol documents. This includes both industry sponsored studies and investigator-initiated studies.
• The eConsent module is recommended for any study wishing to consent participants electronically on FDA regulated studies but can be used for any study desiring to consent electronically.

• Web-based secure system approved for use by IU and IU Health.
• It is 21 CFR Part 11 compliant.
• View and manage all your studies’ regulatory files in one convenient location with customizable folders.
• Centrally store staff credentials and organizational regulatory documents, such as CLIA/CAP certifications, laboratory reference ranges, and study staff licenses/certifications/CVs, to be shared across protocols.
• Efficiently obtain 21CFR Part11 compliant staff/investigator e-signatures on essential documents such as training and delegation logs, protocol signature pages, investigator brochure acknowledgments, etc.
• Allows for storage and management of INDs and departmental SOPs.
• Securely store subject source documentation, such as Notes to File, SAEs, or Subject Diaries, in subject-specific e-binders.
• Securely allows access to sponsors and monitors on site or remotely.
• Leverage multi-site management, allowing a coordinating center to manage essential documents for participating sites.
• eConsent will allow you to associate a consent form with a subject, designate form signers, and route to signers electronically. It also allows you to track the status of all consent forms, send reminders to signers, and edit their contact details as needed.

• Access to eReg can be requested on our website or directly using this link: https://redcap.link/eReg_Access_Request.
• Each employee who requests access to eReg must complete the designated training for the appropriate functional role(s) before access is granted.

• OCR Website
• Contact Alina Adkins at aladkins@iu.edu.

• The Advarra eSource + EDC system will be recommended for any FDA regulated studies utilizing electronic source documentation or electronic case report forms (CRFs) where another validated platform is not provided.
• The use of Biostatistics Data Management services are required and should be included in your budget. More information can be located on their website.

• Web-based secure system approved for use by IU and IU Health.
• 21 CFR Part 11 compliant.
• Captures study data in structured case report forms.
• Efficiently obtain Part 11 compliant electronic signature for PI approval of Case Report Forms (CRFs).
• Includes full traceability and audit capabilities for all data created and modified within the system.
• Ability for User Acceptance Testing prior to live use of any subject forms.
• Allows for Data Monitoring and Data Management signoffs.
• Ability to query data and report and monitor all stages of form/query resolution.
• Includes exportable data dictionary, calendar specifications, and subject casebooks.
• Allows for exportable raw data in SAS format for analysis.
• Allows secure access to sponsors and monitors on site or remotely.

• Access will not be available until Q4 2024.
• Each employee who requests access to eReg must complete the designated training for the appropriate functional role(s) before access is granted.

• Contact Lindsay Mann at limann@iu.edu