22 Jan UW/FHCC Standard Industry Oncology Fee Letter Go Live
Effective 1/2/24: Sponsor approval of the UW or FHCC Standard Industry Oncology Fee Letter is a minimum required document for REDCap New Study Submission.
What is happening?
Sponsor approval of standardized UW and FHCC institutional and administrative fees are required for all new applicable studies. The sponsor approval email and approved version of the fee letter must uploaded as required documents in the REDCap Intake Attachment form.
Updates to OnCore OTA/Activation Task List:
- D105: Fee Letter Outcome Document – Sponsor approval email and approved version of the fee letter will be uploaded in the Initial Documents task list.
- A13: Standard Industry Oncology Fees/Intake Complete – CRS confirms sponsor approval of the fee letter and sends fee exhibit to study submission contact. This does not gatekeep other steps in the task list.
- A32: Standard Industry Oncology Fees/Validated – CRS confirms all mandatory and applicable fees are included in the final negotiated budget. Fee validation by CRS is required prior to initiation of budget entry.
When?
January 2nd, 2024
Which trials does this impact?
All interventional, industry-sponsored oncology clinical trials with negotiable budgets. *Not in scope: cooperative group/NCTN trials, IITs, observational trials, non-negotiable budget trials, specimen/data collection only trials.
Where do the Fee Letters live?
UW and FHCC Standard Industry Oncology Fee Letters are located in OnCore CTMS Docs > CRS Central Startup Resources. For more information, please visit the Standard Industry Oncology Fee Letter FAQ. *Please log into OnCore before clicking links.
Why?
Standardizing industry oncology institutional and administrative fees enable research groups to consistently and efficiently negotiable financially viable new clinical trial budget. It will reduce startup times, disparity among industry oncology contracts, and staff burnout.
For questions please contact CRSstartupRequest@fredhutch.org.