Requirements for Maintaining a Protocol Record in OnCore CTMS
Clinical trials and human subjects research conducted at University of Washington (UW), Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance (SCCA), and Seattle Children’s must be maintained in OnCore CTMS when meeting any of the following criteria:
Epic active studies at UW or SCCA 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 whether the protocol has an Epic billing footprint. 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 financials, subject status and visit tracking, and sponsor invoicing (as required).
How to Create a Protocol Record in OnCore
Study teams should submit a New UW/FH/SCCA 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.
The CTMS Program Office will create a new OnCore protocol record within 24 – 48 hours of the 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/SCCA/FH 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)
SCCA Clinical Operations – Research Services (CORS)
SCCA Investigational Drug Service (IDS)
Clinical Research Support (CRS)
SCCA Clinical Information Systems (CIS) Research Orders
Study Start-Up Sponsor Letter
Starting 09/08/2022, the minimum required documents for REDCap Clinical Research Intake will be expanded to include all applicable documents. The requirements vary by study type, ancillary participation, oncology/non oncology research, location and other attributes. Ansers to questions within the REDCap form will determine the requirements.