SOP Intro
The Clinical Research Support Office (“CRSO”) has developed policies and procedures guiding both the internal processes of the CRSO and expectations from partners in the Research community.
The Standard Operating Procedures (“SOP”) help define standard practices and daily processes conducted to assure the execution of tasks in accordance with institutional policies, state, and federal regulations.
The Work Instructions provide detailed steps including use of the clinical trials management system (“CTMS”) OnCore meant to aid in day-to-day processes with step-by-step instructions.
Standard Operating Procedures and Work Instructions
OnCore CTMS Management
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:
Protocol Management
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:
Coverage Analysis
Formalize a compliant coverage analysis process observant of the rules and regulations surrounding billing and payment for routine costs in clinical trials.
SOPS:
Supporting Documents:
Subject Management
Ensure that subject visit data is entered in the CTMS appropriately and promptly to enable accurate invoicing and research billing compliance processes.
SOP:
Supporting Documents:
- UK Clinical Research Subject Management Guidelines
- Subject Console - Minimum Data Footprint
- OnCore/Epic Demographics Tip Sheet
- OnCore Subject Status Flowchart
Videos:
Financial Management
Standardize financial management of clinical trials across departments, enable transparent and compliant accounting practices, and support enterprise reporting.
SOPS:
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
Additional Resources
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