What is this service?
Study management mentoring services empower study teams to efficiently plan, initiate, and manage their research study using standard tools and best practices. A mentor can provide guidance on protocol development, IRB submission, adherence, and study progress through completion.
Working with a mentor, the team will discover efficient and practical solutions that align with the specific needs of the project and generate high quality results. Mentoring services are available,but not limited to, the following areas:
- Management of multicenter clinical projects from protocol implementation through study completion
- Preparation and negotiation of budgets and contracts
- Preparation of multi-site informed consent templates
- Management of regulatory document submission
- Maintenance of the operational study file
- Coordination of meetings (i.e. investigator, team, DSMB, study coordinator, etc.)
- Editing and distribution documents (i.e. newsletters, reports, safety plans, etc.)
- Subject recruitment/enrollment
- Issues regarding compliance
- MedDRA and WHODRUG coding processes
Who can use this service?
These services are available to all study teams.
When should I contact MICHR about this service?
You should contact MICHR about study management services before you start your study.
How much does this service cost?
Mentoring services are fee-based and are billed at an hourly rate.