The Central Startup Team facilitates comprehensive study startup on behalf of research groups for industry-sponsored oncology clinical trials.
Comprehensive startup services include: initial intake and site minimum requirement collection; assignment to the central startup team; all required clinical trial management system submissions; internal and external regulatory submissions, budget development and negotiation; clinic implementation; site training/supply/access requests from site qualification to RG-activation.
Additional resources and recommendations for negotiating industry-sponsored clinical trial budgets are available in OnCore under CRS Budget and Startup Resources (Fixed and Recommended Rates for Industry Sponsored Trial Budgets). Please contact the Central Startup Team for more information about comprehensive startup support.
Key Contacts
CRSstartupRequest@fredhutch.org for assistance with new intake, rate card and fee letters
CRSstartup@fredhutch.org for assistance with active startup
CRSamendments@fredhutch.org with assistance with amendments
- Facilitate structured intake and minimum requirement collection for newly selected industry-sponsored trials
- Provide comprehensive study startup services which meet research group goals and expectations and establish a foundation for successful study management
- Provide excellent customer service and maintain regular communication with study teams and sponsors throughout the startup progress
- Attain RG Activation within 100 days of New Study Submission to REDCap
- Structured intake prior to study startup assignment
- Minimum document collection from sponsor
- dedicated and integrated study startup specialists assigned to each study
- Industry and institutional implementation expertise
- Weekly progress updates
- New Study Submission to REDCap
- Clinic implementation/operations liaison with sponsor
- OnCore Calendar receipt/vetting/finalization
- 3rd Party Coverage Analysis receipt/finalization w/PI
- Budget development/negotiation/finalization
- OnCore Budget Entry vetting
- Contract finalization/execution
- Essential Regulatory Package & site training documentation (1572, FDFs, CVs, MLs, etc.)
- ICF development/negotiation/finalization
- Ancillary review submissions/approvals (SRC, Radiation Safety, HSD, IBC, IRO, etc.)
- Initial IRB submission/approval/correction(s)
- Vendor certificates/portal access
- Supplies and equipment shipment coordination
- Internal registration with required service areas (pathology, specimen processing, UW OncoRad/TIMC, etc.)
- SIV coordination, scheduling, and co-facilitation
- Complete study startup file delivery
- Detailed summary of startup activities
Active Engagement from Research Group
- Video-on attendance and discussion at required virtual meetings (Study Kickoff and Study Handoff)
- Timely approvals throughout startup workflow
- Timely responses to “Study Team/PI Action Required” items included in the Study Startup Progress Updates each week
Research Group Standards/Practices
- Financial requirements
- ICF development process
- Staff list
- Clinic implementation practices