Requirements for Maintaining a Protocol Record in OnCore CTMS
Clinical trials and human subjects research conducted at University of Washington (UW), Fred Hutchinson Cancer Center and Seattle Children’s must be maintained in OnCore CTMS when meeting any of the following criteria:
- Epic active studies at UW or Fred Hutch clinical sites
- Oncology-related human subjects research
- Fred Hutch non-oncology human subjects research
- Expanded Access INDs under Institutional Review Board (IRB) oversight
Minimum requirements for maintaining a protocol record in OnCore vary depending on the type of research (e.g., observational, interventional), if the research is oncology-related or non-oncology and if the protocol is active in UW/Fred Hutch Epic. Data entry requirements for OnCore protocols include basic protocol information (e.g., protocol staff, participating institutions, protocol sponsors, etc.), IRB and other committee approvals and subject accruals. Epic active protocols with a billing grid and budget also require study financials, subject status and visit tracking and sponsor invoicing (as required).
Please note that if a Protocol has already been created, but it requires an edit or change, the Study Amendment pathway should be utilized.
How to Create a Protocol Record in OnCore
Study teams will submit a New UW/Fred Hutch Study Submission REDCap survey to initiate the creation of a new protocol record in OnCore. This submission should occur when the protocol is finalized (not expected to change) and before IRB submission. Study documents required at submission may include (as applicable to the protocol):
- Protocol
- Consent Forms
- IDE Letter
- CSTD/SPIROS Document
- DSMB Charter Document
- IDS SOP Approval
- Safety Data Sheet
- Draft Sponsor Contract Template
- Draft Sponsor Budget
- Investigator/Drug Brochure
- Study Manuals (device, pharmacy, imaging, etc)
The CTMS Program Office will create a new OnCore protocol record within 24 – 48 hours of a complete REDCap survey submission. The study team will be notified via email when a new protocol record is created in OnCore, along with guidance on minimum data entry and staff training requirements.
Protocol Intake and Activation Workflows Tracked in OnCore
After a New UW/Fred Hutch Study Submission survey is completed, study intake and activation processes will be tracked via task lists within the OnCore protocol record. Offices that utilize OnCore for tracking protocol intake workflows include:
- UW Clinical Trials Office (CTO)/Clinical Research Budget & Billing (CRBB)
- Fred Hutch Clinical Operations – Research Services (CORS)
- Fred Hutch Investigational Drug Service (IDS)
- Clinical Research Support (CRS)
- Fred Hutch Clinical Information Systems (CIS) Research Orders
Study Start-Up Sponsor Letter
