SOPs and Work Instructions The CRSO is pleased to announce the issuance of the following groupings of policies and procedures. Additional training materials can be found on the OnCore CTMS Resources website by clicking the button below.

Standardized management of the OnCore CTMS database across the institution.

SOPs:

• OnCore CTMS Login Access
• Downtimes and Disaster Recovery
• Data Governance and Change Management
• Demographics Interface
• RPE Interface
• Data Monitoring Escalation

Supporting Documents:

• CTMS Login Access
• OnCore Widgets
• OnCore Access Request Process Flowchart

Standardize the activation process, ongoing management, and closeout process for all clinical trials as defined by the NIH and any clinical research study that involves UKHC billing activity.

Supporting Documents: 

• New Study Request via REDCap
• Amendment Submission via REDCap
• PC Console - Minimum Data Footprint
• Annotations Form
• OnCore Protocol Status and Signoffs
• PC Console Accrual Goals & Completion Dates
• Protocol Lifecycle Checklist
• RPE Protocol Checklist
• Managing Protocol Staff
• Initial RPE Eligibility Review Process Flowchart

Videos:

• OnCore Protocol Status New to Open to Accrual
• OnCore IRB Review Entry

Formalize a compliant coverage analysis process observant of the rules and regulations surrounding billing and payment for routine costs in clinical trials.

SOPS:

• Research Billing Integrity Process including Coverage Analysis
• MCA Fee Processes

Supporting Documents:

• Clinical Research Billing Integrity Policy

Ensure that subject visit data is entered in the CTMS appropriately and promptly to enable accurate invoicing and research billing compliance processes.

SOP: 

• Subject Data Lifecycle Management

Supporting Documents:

• UK Clinical Research Subject Management Guidelines
• Subject Console - Minimum Data Footprint
• OnCore/Epic Demographics Tip Sheet
• OnCore Subject Status Flowchart

Videos:

• Subject Status and Calendar
• Research Visit and Procedure Tracking
• My Console

Standardize financial management of clinical trials across departments, enable transparent and compliant accounting practices, and support enterprise reporting.

SOPS: 

• Budget Monitoring
• Amendments

Supporting Documents:

• Financials Console - Parameters
• Financials Console - Protocol Related and Protocol Events
• Financials Console - Milestones
• Financials Console - Invoices and Invoiceable Items
• Financials Console - Receipts
• Financials Console - Visit Variations
• Financials Console - Invoicing Rules

Resources related to processes beyond the categories listed above.

Supporting Documents:

• Summary Accrual Work Instructions
• Troubleshooting OnCore Web-App Cache Issues
• OnCore Credentials Management
• OnCore and Epic RPE End User Reference

Videos:

• What Not To Do in OnCore Part 1
• What Not To Do in OnCore Part 2