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. 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