| 1 |
Process transformation |
Sequential process with lag time between process steps, rework needed and no central coordination |
Parallel process with emphasis on first-time quality and central coordination
Overall process changes
Require that completed protocols with all manuals be submitted for review to reduce rework IRB reviews application and works with study team to improve quality before submission; this process is in parallel with ancillary committee reviews All items are reviewed to ensure first-time quality during activation checkpoint Preparation of legal contracts and budgets occurs to greater extent in parallel. Regularly discuss and track budget, timelines, and deliverables with sponsors Semiweekly activation team meetings Development of detailed work instructions organized by user role Committee reviews
Integrate 3 separate radiation safety committees at each campus into single committee Abbreviated timeline for ancillary scientific committee reviews (eg, Clinical Research Unit, Radiation Safety, Radiology) to 7 d
|
| 2 |
Contract signature |
Sequential process between IRB approval and contract signature results in delayed activation timeline |
Parallel vs sequential process approach Signatures not reliant on IRB approval Shortened negotiation timeline Accelerated timelines for resolving issues within institution Start negotiations with bottom-line or compromise position Manage handoffs in automated (vs manual) manner Increased communications between Mayo Clinic internal departments Earlier engagement with sponsor on contract negotiations Increased use of ACTA and master agreements Executed 11 new master research agreements with industry partners in 2014 and 9 in 2015 Refined and accelerated process for internal language reviews to ensure timely responses to move forward Seven business days to review initial contract from sponsor, propose edits, and return contract to sponsor. Hold initial phone conference 5 days after submitting edited contract to sponsor. Ensure decision-makers are on phone conference to finalize contract negotiations Eliminate multiple negotiation cycles Eliminate handoff between OSPA and LCA. After execution of contract, LCA uploads the fully executed agreement into OSPA’s financial database (savings of 1 or 2 days) allowing timely submission to Research Accounting to obtain account numbers Eliminate redundant notifications between LCA and OSPA to study staff and research personnel, eliminating waste in the process Develop communication plan, with escalation points, between OSPA and LCA during budget and contract negotiations, to provide seamless approach to industry sponsor
|
| 3 |
Budgets and coding solutions |
Complex procedure code identification process |
Simplified process of identifying procedure codes
Reduction in duration of budget negotiation timeline
Code and coverage analysis
Reduce number of procedure codes in electronic system Optimize the tool that allows users to identify frequently used codes Equip study teams with ability to assess budget feasibility early in the process, to facilitate more informed discussions with external sponsors Enhance efficiency by developing code and coverage analysis templates that incorporate standard patient care schedule codes for specific disease groups which use the same laboratory tests, scans, and other diagnostic tests. A specific disease group template may be copied and used as a starting point for a new CCA Budget negotiation
Use sponsor, rather than Mayo Clinic, template to prepare budget Standardize study start-up and pharmacy fees for all Mayo Clinic sites Estimate study staff effort per visit vs annually
|
| 4 |
Facilitation |
Clinical trial activation managed by individual study teams |
Central coordination of clinical trial activation
Facilitator coordinated the process, with emphasis on open communication, timeline expectations, and accountability |
| 5 |
Prioritization |
No prioritization criteria established |
Industry-funded clinical trials prioritized through work queues of business units involved in the activation process Standard prioritization process developed to ensure activation within 65 calendar days Fast-track prioritization criteria; limits and process developed for subset of clinical trials that need activation in <65 calendar days
|
| 6 |
IT coding solutions |
|
Electronic system enhancements to support outcomes of other subprojects
Enhancements to Mayo Clinic’s Integrated Research Information System to support process flow changes, biospecimen changes, prioritization and removal of 2 system hard stops Consent form reviewer enables collaborative reviews and edits Dashboard clearly shows timeline performance of each study vs target timelines for each process step
|
