OnCore: SMPH Oncology Other Research Group (ORG) Guide
What is an Other Research Group (ORG)?
An ORG is a group conducting a cancer-related research study that is not part of an established University of Wisconsin Carbone Cancer Center (UWCCC) Disease Oriented Team (DOT).
How are ORG protocols handled in OnCore?
ORG protocols must go through the UWCCC Protocol Review and Monitoring Committee (PRMC). This is the scientific review committee mandated by the National Cancer Institute (NCI) to ensure the scientific integrity of protocols conducted at the UWCCC.
A brief overview of the process:
- The protocol is set up in OnCore by PRMC staff after the ORG staff submit the ORG PRMC Initial Protocol Submission Form.
- When complete, the application is entered into ePRMS (electronic Protocol Review and Monitoring System) and an OnCore record is created.
- When the application is approved, the protocol can be submitted to the IRB (Institutional Review Board).
- The ORG study team is responsible for creating a calendar in OnCore and entering financial information, as applicable.
- The ORG staff requests SMPH Review when ready.
- PRMC assists with PC Signoff before opening to accrual.
- After opening to accrual, ORG study team is responsible for updating study and subject information in OnCore.
- If the study team needs to make a major amendment, this must be submitted to PRMC for approval.
Full detailed instructions, links to forms, and additional information is available on the ORG PRMC Submission SOP.
What resources are available for ORG study teams?
Questions to Answer Before Creating a New SMPH Protocol in WISC OnCore
- Start here before creating your WISC protocol to ensure you follow the correct process for protocol creation
- Full detailed instructions, links to forms, and additional information about ORG protocols
OnCore Clinical Trials Management System (CTMS)
- Lists links to UWCCC Data Field Definitions (DFDs)
ORG Study Team Responsibilities
- Includes a flow chart of the responsibilities undertaken by the study team, UWCCC Clinical Research Central Office (CRCO), and UWCCC Protocol Activation Coordinator (PAC)
- Basic requirements for ORG Protocol Maintenance