Standard Operating Procedures

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.

The Workflows support the policies and work instructions with visual representation of process and responsible parties.

Protocol Start-Up

Policy Purpose: Ensure all Clinical Trials as defined by the NIH participate in a standardized activation process including the submission of required documents and information before submission for Institutional Review Board (“IRB”) approval.

Supporting Documents: The PC Console (OnCore module where protocol level data is entered) Work Instructions, New Protocol Set-Up and OnCore Signoffs workflows outline the steps to notify the CRSO of new trials and how protocol information is entered in OnCore.

Coverage Analysis

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

Supporting Documents: The Coverage Analysis work instructions and workflow outline the steps in the coverage analysis request, build, and signoff process.

Financial Management (Budgets, Invoices, and Sponsor Payments)

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

Supporting Documents: The Budget and Sponsor Invoicing and Payment Processing work instructions give details on how to build and update budgets in OnCore, and how to use OnCore and its interface to SAP for sponsor invoicing and payment processing. The Pre-Award and Budget Entry and Sponsor Invoicing and Payment Processing workflows give a visual representation of these processes.

Budget Review SOP

Subject Management

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

Supporting Documents: The Subject Admin work instructions outline steps for study teams to register subjects and enter visit data in OnCore. The Subject Management workflow outlines these processes at a high level.

Serious Adverse Events (“SAE”s), Adverse Events (“AE”s), Deviations, and Unanticipated Problems (“UP”s)

Policy Purpose: Standardize SAE, UP and Deviation reporting requirements in the CTMS and enable reporting of serious adverse event and subject safety information. This policy does not remove the responsibility of the study team to follow federal, IRB or Study Sponsor requirements.

Supporting Documents: The SAEs and Ups and Deviations and Violations work instructions outline the steps to document these in the CTMS. The Deviations, Violations, SAEs, UPs workflow outlines the high-level workflows for these processes.

Amendments

Policy Purpose: Ensure all applicable trials go through a standardized amendment process and the responsible parties complete all appropriate steps for studies built in the CTMS per the minimum footprint.

Supporting Documents: The Amendments work instructions and workflow support the policy with details on how different amendments are handled (e.g. amendments that impact calendars, coverage analysis, and budgets; budget only amendments; coverage analysis only amendments).

Amendments CFI-SOP

Protocol Closeout

Policy Purpose: Standardize the process for how clinical trials are closed in the CTMS following study completion, ensuring that trials are closed in alignment with IRB and other financial processes, and that all accounts have been reconciled and distributed per University of Kentucky practices.

Supporting Documents: The Protocol Closeout work instructions and Protocol and Financial Closeout workflow outline the steps in more detail.